CTRI/2020/03/024402 [Registered on: 31/03/2020] Trial Registered Prospectively
Last Modified On:
31/03/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Hydroxy Chloroquine, in open labelled, Randomised intervention for prevention of new infection and adverse outcomes following COVID-19 infection -A Tertiary Hospital based study
Scientific Title of Study
Hydroxy Chloroquine, in open labelled, Randomised intervention for prevention of new infection and adverse outcomes following COVID-19 infection- A Tertiary Hospital based study
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Remesh Bhasi
Address
Aster Malabar Institute of Medical Sciences (MIMS)
P O Govindapuram
Kozhikode
Kerala
India 673016
Group 2 :
400 mg bd for one day followed by 400 mg weekly for 7 weeks to be taken with meals (or until the epidemic stops) (ICMR Regimen)
Both groups will be advised to follow strict measures of self hygiene, social distancing and other routine protocols issued by IMA and Government bodies to prevent transmission.
Intervention
Hydroxychloroquine
300 mg daily x 7 days followed by 300 mg weekly x 7 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Moderate to high risk of exposure to infected patients during the study period.
2. Healthy at the time of enrolment without any symptoms suggestive of any viral infection.
ExclusionCriteria
Details
1. History of known allergy to Hydro ChloroQuine(HCQ) or Chloroquine
2. Known contraindications for HCQ or Chloroquine including Retinopathy, known Cardiac disease like Dysarrythmias, and G6PD deficiency.
3. Pregnancy and Lactation
4. History of recent (within one month) International travel.
5. Features of any ongoing infection including COVID-19
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Infected Non infected
Time to clinical improvement
Secondary Outcome
Outcome
TimePoints
Mortality, percentage of patients who had clinical improvement, oxygen support days, Mechanical ventilation, ICU stay days, total hospital stay, clinical score, MODs plus or minus
28 days mortality
7 day and 14 day clinical score and all others at the time of discharge
Hydroxychloroquine sulphate tablets will be given in the dose of 400 mg twice on day 1 and then 400 mg once in a day for 04 days daily to the patients who meets the inclusion criteria
Comparator Agent
No drug
Hydroxychloroquine will not be given to control group. These patients will be managed as per standard protocol.
Inclusion Criteria
Age From
14.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
a. Patients with oxygen saturation (SPO2) less than 95%
b. Respiratory rate is more than 20/min
c. Pulse rate more than 90/min
d. Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities, consolidation and Acute Respiratory Distress Syndrome (ARDS)
ExclusionCriteria
Details
a. Asymptomatic patients
b. Patients with mild illness (not satisfying inclusion criteria)
c. Patients allergic to chloroquine
d. Patients less than 14 years of age
e. Patients unwilling for informed consent
f. Pateints with prolonged QTc interval on ECG
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
number of days of hospitalization
discharge
Secondary Outcome
Outcome
TimePoints
death
days to normalization of SaO2
days to normalization of pulse rate less than 90/min
number of days of requirement of oxygen
number of days from admission to ventilator requirement
number of days on ventilator and occurrence of side effects
death or discharge
Target Sample Size
Total Sample Size="32" Sample Size from India="32"
In December 2019, an outbreak of an emerging disease (COVID-19) due to a novel coronavirus (named SARS-CoV-2 later) started in Wuhan, China, and rapidly spread in China and outside. The disease rapidly spread to European countries and American countries. India also started reporting cases of COVID 19 from various states. The etiologic agent responsible for the present outbreak of COVID 19 is a novel Coronavirus, closely related to the SARS-Corona virus, and has been named as SARS-CoV-2. Hydroxychloroquine/Chloroquine has been demonstrated to have an anti- SARS-CoV 2 activity in vitro. In one open-labeled non-randomized French study, chloroquine/Hydroxychloroquine has shown a significant reduction in viral load compares to the control group. The aim of the study is to determine whether Hydroxychloroquine is beneficial in COVID-19 patients who present with Severe Acute Respiratory Illness (SARI). In our study, we propose to determine the effectiveness of hydroxychloroquine in reducing the number of days of hospitalization in intervention as opposed to the control group.
It will be an open-labeled randomized controlled trial. A total of 32 patients (16 in each group) will be taken into the study. Sample size calculation has been done using online calculator ClinCalc.com assuming the primary endpoint being the number of days of hospitalization. Assuming an average patient of COVID-19 infection with SARI will stay in the hospital for a mean of 15±5 days the intervention will be considered significant if the intervention reduces the number of days by a one third i.e. a mean of 10 days. The alpha error is 0.05 and the power of the study is 80%. The study will be conducted in this hospital on patients who are detected to be COVID 19 positive based on Reverse Transcription Polymerase Chain Reaction (RT PCR). All the patients meeting inclusion criteria will be enrolled in the study. Computer-generated randomization will be done to enroll patients in the intervention group and control group respectively after taking consent. Those in the intervention group will receive chloroquine 500 mg two times per day for 10 days. The patients in the control group will not receive hydroxychloroquine.
The project has significant scope to add to the existing repertoire of understanding about the management of COVID-19. It will tell us about the effectiveness of hydroxychloroquine in the treatment of COVID-19
CTRI Number
CTRI/2020/05/025067 [Registered on: 06/05/2020] Trial Registered Prospectively
Last Modified On:
12/04/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19
Scientific Title of Study
A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Professor Vivekanand Jha
Address
The George Institute for Global Health, India
311-312, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
New Delhi DELHI 110025 India
Phone
911141588091
Fax
911141588090
Email
vjha@georgeinstitute.org.in
Details Contact Person Scientific Query
Name
Professor Vivekanand Jha
Address
The George Institute for Global Health, India
311-312, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
DELHI 110025 India
Phone
911141588091
Fax
911141588090
Email
vjha@georgeinstitute.org.in
Details Contact Person Public Query
Name
Professor Vivekanand Jha
Address
The George Institute for Global Health, India
311-312, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
DELHI 110025 India
Phone
911141588091
Fax
911141588090
Email
vjha@georgeinstitute.org.in
Source of Monetary or Material Support
George Institute for Global Health India
Primary Sponsor
Name
George Institute for Global Health India
Address
George Institute for Global Health, India
311-312, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
New Delhi 110025
Prophylaxis with hydroxychloroquine in COVID-19 infections
Intervention / Comparator Agent
Type
Name
Details
Intervention
hydroxychloroquine along with Standard care Personal protective equipment
800 mg of hydroxychloroquine on the day of enrollment and 400mg once a week after that for a total of 12 weeks
along with standard care Personal protective equipment
Comparator Agent
Standard care Personal protective equipment
standard care Personal protective equipment
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
All HCWs directly exposed to confirmed COVID-19 patients.
ExclusionCriteria
Details
Participants who meet any of following criteria will be are excluded
1. have a proven diagnosis of COVID-19 infection
2. are currently taking chloroquine or HCQ
3. are pregnant
4. are breast feeding
5. known QT prolongation
6. history of serious cardiac dysrhythmias or cardiomyopathy
7. have maculopathy of the eye (a contra-indication to HCQ)
8. are immunocompromised because of a disease or therapy
9. pregnant women
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months
Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months
Secondary Outcome
Outcome
TimePoints
1. hospitalization due to suspected COVID-19 disease,
2. admission with suspected COVID-19 to either an ICU or HDU ,
3. all-cause mortality,
4.organ failure
5. duration of ICU or HDU stay,
6. Need for vasopressors
7. Need for renal replacement
8. duration of hospitalization,
9. readmission to hospital
10.days off work
Tirupakuzhi Vijayaraghavan, B. K., Jha, V., Rajbhandari, D., Myatra, S. N., John, O., Ghosh, A., ... & Venkatesh, B. (2020). Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation (HOPE) trial: A structured summary of a study protocol for a randomized controlled trial. Trials, 21(1), 1-3.
Brief Summary
This study
aims to Evaluate whether a strategy of prophylaxis with hydroxychloroquine(HCQ) taken weekly for 3
months reduces the risk of acquiring symptomatic COVID-19 infections among
healthcare workers.
There are no human studies of HCQ prophylaxis. The Indian Council of
Medical Research in its advisory recommended 400 mg to be taken twice on D1
followed by 400mg once a week for 7 weeks. We anticipate longer durations of
exposure for most HCWs working in COVID-19 wards based on current number of
cases and expected Indian and International trajectories. We have hence chosen
the 12-week prophylaxis duration. Given the reassuring safety data on HCQ, we
think 12 weeks is a reasonable and safe duration.
Potential
participants will be referred to the research team by treating physicians and
other COVID-19 ward and ICU staff. The research team will confirm eligibility
and the principal investigator and co‐investigators will confirm whether the
participant can be approached for consent.
At baseline
information will be collected on designation, role in COVID ward (nurse,
physician, physiotherapist, dietitian, housekeeping personnel etc.),
demographics, average shift duration, and comorbidities.
During follow-up data will be collected on
proportion of HCWs that develop symptomatic and laboratory confirmed COVID-19
infection (yes/no) and a host of secondary outcomes.
CTRI Number
CTRI/2020/05/025242 [Registered on: 19/05/2020] Trial Registered Prospectively
Hydroxychloroquine of pharmacokinetics in healthcare workers
Scientific Title of Study
Population pharmacokinetics of hydroxychloroquine sulphate in healthcare workers given for prophylaxis against Corona Virus Disease 2019 (COVID 19) pandemic in India
Secondary IDs if Any
Secondary ID
Registry
83341
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Nithya Gogtay
Address
Dept of Clinical Pharmacology 1st floor MS building
Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai
Asymptomatic Health Care workers (HCWs) of any gender and conditions as follows:
age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection – Group 1 without comorbiditie
age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis – Group 2 without comorbidities
age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection with comorbidities (HT, Diabetes) – Group3
age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis – Group 2 with comorbidities (HT, Diabetes)
ExclusionCriteria
Details
Health care workers who show symptoms suggestive of COVID-19 or are positive for COVID-19
Women of child bearing potential who are not willing for adequate contraception during the time of blood collection / who were not practicing adequate contraception in the last 28 days
Women who are pregnant or breast feeding
Participants who are not determined to be fit by the investigator
Participants who are prescribed HCQ for any other indication / history of taking HCQ in the last one year
The modelling will help assess which of the variables including the presence of comorbidities (if any) would have the greatest impact on the drug concentrations in an Indian population. It would also help us understand if COVID-19 infection alters the pharmacokinetics of HCQ.
Corona Virus Disease 2019 (COVID-19) had its origin in Wuhan, China in December 2019 and was subsequently found to have been caused by a novel corona virus named severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). It later spread to many nations and the World Health Organisation declared it a pandemic on 12 March 2020. As the health crisis was looming all over the world with thousands reported to have contracted the disease, some of whom died, the search for various treatment options took great priority. Accordingly repurposing of old and approved drugs such as chloroquine, hydroxychloroquine (HCQ), azithromycin, metformin, angiotensin receptor inhibitors such as sartans, or statins such as simvastatin were considered to be useful for the treatment of this disease. [4] Of these, hydroxychloroquine has garnered much attention as a potential prophylactic / treatment option for COVID-19.
With mounting evidence on the possible beneficial effect of HCQ in the prevention and treatment of COVID-19, there is limited information on the pop PK of HCQ in an Indian setting when administered for the prophylaxis of COVID-19. Thus, the current study gains greater importance given the current pandemic with COVID-19.
CTRI Number
CTRI/2020/04/024904 [Registered on: 28/04/2020] Trial Registered Prospectively
Last Modified On:
28/04/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Treatment of COVID19 : A randomised controlled trial
Scientific Title of Study
Randomised Controlled Trial to compare efficacy of hydroxychloroquine alone and in combination with azithromycin in treatment of COVID-19
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
AirCmde V K Sashindran
Address
Has Central Air Command
Air Force Station Bamrauli
Prayagraj
Allahabad UTTAR PRADESH 211012 India
Phone
919958826493
Fax
Email
vksashindran@gmail.com
Details Contact Person Scientific Query
Name
AirCmde V K Sashindran
Address
Has Central Air Command
Air Force Station Bamrauli
Prayagraj
HCQ 400mg BD AZT 500mg OD D1
HCQ 400mg OD AZT 250 mg OD D2 - D5
Intervention
HCQ high dose (HCQh)
HCQ 600mg BD D1
HCQ 300mg BD D2 - D5
Intervention
Hydroxychloroquine sulfate (HCQs)
HCQ 400mg BD on D1 and 400 mg OD on D2 - 5
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
Age > 18 years
All sexes
Case definitions for inclusion in the study will include mild, moderately severe and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020.
Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI)
Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%).
Severe: Severe Pneumonia (with respiratory rate ≥30/minute and/or SpO2 < 90% in room air) or ARDS or septic shock
Laboratory confirmed SARS CoV-2 infection within last 10d or SARS CoV-2 test result pending with a high clinical suspicion as defined by:
Cough of <10d duration
Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air
No alternative explanation for respiratory symptoms
Scheduled for admission or enrolled within 48h of hospital admission
ExclusionCriteria
Details
Children < 18 years
Pregnant or lactating women
Symptoms of acute respiratory tract infection for > 10d before randomisation
More than 48h have elapsed between meeting inclusion criteria and randomisation
Seizure disorder
Known case of G6PD deficiency
Diagnosed long QT syndrome
QTc >500ms on ECG within 72h prior to enrolment
Chronic haemodialysis or GFR<20 ml/min
Psoriasis or porphyria cutanea tarda
Severe liver disease
Any subject who has received the following drugs in the 12h period before enrolment or who is likely to receive the following during the period of therapy with HCQ / HCQ + AZT / AZT: amiodarone, cimetidine, phenobarbitone, phenytoin, digoxin
Receipt of >1 dose of HCQ / AZT in 10 days prior to enrolment
Known allergic reactions to HCQ or azithromycin
Inability to take/receive enteral medication
Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital)
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
COVID Ordinal Outcomes Scale is defined as:
1. Death
2. Hospitalised on invasive mechanical ventilation or extracorporeal mechanical ventilation ( ECMO)
3. Hospitalised on non-invasive ventilation or high-flow nasal cannula oxygen therapy
4. Hospitalised on supplemental oxygen
5. Hospitalised not on supplemental oxygen
6. Not hospitalised with limitation of activity (due to continued symptoms)
7. Not hospitalised without limitation in activity (no symptoms)
D14
Secondary Outcome
Outcome
TimePoints
All location, all-cause mortality assessed on D14 (Time frame- assessed on 14th day of starting treatment) Vital status of patient will be ascertained from medical record review, phone call to patient or proxy
D14
All location, all-cause mortality on D28 (Time frame- assessed on 28th day of starting treatment) Vital status of patient will be ascertained from medical record. review, phone call to patient or proxy
D28
Compare groups with regards to acute kidney injury to D28 (The number of patients who have acute kidney injury between starting treatment and 28th day will be determined)
D28
Compare groups with regards to acute pancreatitis to D28 (The number of patients who have acute pancreatitis between starting treatment and 28th day will be determined)
D28
Compare groups with regards to atrial or ventricular arrhythmia to D28 (The number of patients who have atrial or ventricular arrhythmias between starting treatment and 28th day will be determined)
D28
Compare groups with regards to cardiac arrest to D28 (The number of patients who have cardiac arrests between starting treatment and 28th day will be determined)
D28
Compare groups with regards to elevation of aspartate aminotransferase to D28 (The number of patients who have aspartate aminotransferase level more than two times upper limit of normal between starting treatment and 28th day will be determined)
D28
Compare groups with regards to neutropenia, lymphopaenia, anaemia or thrombocytopenia to D28 (The number of patients who have neutropenia, lymphopaenia, anaemia or thrombocytopenia between starting treatment and 28th day will be determined)
D28
Compare groups with regards to seizures to D28 (The number of patients who have seizures between starting treatment and 28th day will be determined)
D28
Compare groups with regards to severe dermatologic reaction to D28 (The number of patients who experience severe dermatologic reaction between starting treatment and 28th day will be determined)
D28
Compare groups with regards to symptomatic hypoglycaemia to D28 (The number of patients who experience symptomatic hypoglycaemia between starting treatment and 28th day will be determined)
D28
COOS on D28 (COOS will be determined for all patients on 28th day day of starting treatment)
D28
COOS on D7 (COOS will be determined for all patients on 7th day of starting treatment)
D7
COVID Ordinal Outcomes Scale on D2 (COOS will be determined for all patients on 2nd day of starting treatment).
D2
Hospital-free days through D28 (28th day of starting treatment. Hospital free days is defined as 28 minus the number of days from enrolment to discharge to home. If patient has not been discharged to home by D28 or dies during hospitalisation, he will be assigned a value of zero
D28
ICU-free days through D28 (28th day of starting treatment. ICU free days is defined as 28 minus the duration of ICU days through the 28 days. Patients not surviving up to D28 will be assigned a ICU-free days value of zero.)
D28
Number of patients receiving renal replacement therapy to D28 (The number of patients who receive renal replacement therapy between starting treatment and 28th day will be determined)
D28
Oxygen-free days through D28 (28th day of starting treatment). Oxygen-free days is defined as 28 minus the duration of days through the 28 days when he received Oxygen therapy. Patients not surviving up to D28 will be passing a ventilator-free days value of zero.)
D28
Vasopressor-free days through D28 (28th day of starting treatment. Vasopressor free days is defined as 28 minus the duration of vasopressor support days through the 28 days. Patients not surviving up to D28 will be assigned a vasopressor-free days value of zero.)
D28
Ventilator-free days through D28 (28th day of starting treatment. Ventilator free days is defined as 28 minus the duration of ventilated days through the 28 days. Patients not surviving up to D28 will be assigned a ventilator-free days value of zero.)
D28
Target Sample Size
Total Sample Size="300" Sample Size from India="300"
The study will follow all guidelines as mentioned in the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI)by the World Health Organisation.
No definite treatment is recommended for COVID19 caused by the novel SARS Cov-2. The current standard of care is only supportive. In vitro studies and small clinical studies in China have demonstrated clinical efficacy of Chloroquine/hydroxychloroquine and combination therapy of hydroxychloroquine and azithromycin. Antiviral properties of Azithromycin have also been demonstrated. However, the exact dosage of the medication and duration of treatment are not well established. This study wants to determine the efficacy of hydroxychloroquine in standard dose and high dose separately and standard dose in combination with azithromycin in treatment of COVID-19. If efficacy is proven, then early treatment will decrease infectivity of cases and also lead to quicker recovery which will decrease burden on healthcare facilities.
Background
SARS CoV-2 is a novel corona virus that has led to a pandemic of respiratory illness with high mortality. It is predominantly spread by respiratory droplets and also by fomites [1]. Both asymptomatic and symptomatic patients can transmit the virus [2, 3, 4]. Average period of transmission is estimated to be 5 - 14 d but transmission upto 28 d is known. The disease was initially discovered when a series of unusual pneumonia cases were detected in Wuhan, China [5]. The commonest presentation is an influenza-like illness. Fever, dry cough and breathlessness are the commonest symptoms reported [6, 7]. Case Fatality Rate (CFR) at present is estimated to be between 0.25 - 3 [8] Elderly, those with heart disease, respiratory disease or diabetes and a combination of these are found to be at highest risk [9, 10]. No definite treatment is known and at present guidelines only recommend supportive care. A rapid cure can result in decreased period of infectivity and also decrease respiratory morbidity and mortality. Various trial drugs are being tested. Lopinavir-ritonavir combination has not been found to be effective in one study [11]. Hydroxychloroquine has been found to have both in vitro and in vivo antiviral properties. It also decreases progression to ARDS in patients with severe pneumonia by its immunomodulatory effects [12, 13, 14]. Various dosage regimes have been suggested based on modelling studies and small clinical observational studies. Yao and colleagues recommend a dose of hydroxychloroquine 400 mg BD on D1 and 400mg daily on D2 - 5 based on their modelling study [13]. Cumulative toxicity of chloroquine occurs beyond 5g and the drug has a large volume of distribution with an elimination half-life of 20 - 60d and with a tendency to accumulate in higher concentrations in metabolically active tissue than in the serum [15, 16].
Azithromycin has also been shown to have antiviral activity especially against Ebola and Zika viruses. AZT induces antiviral responses in bronchial epithelial cells. AZT decreases viral replication of rhinovirus. Their combination is hypothesised to have synergistic effect but this has not been proven yet. The combination of HCQ +AZT has proven to be effective in Ebola. SARS Cov-2 clearance has been demonstrated in patients administered a combination of HCQ +AZT [17]. Other drugs like Remedesivir, favipravir and Chinese herbal medicines are all being studied in various trials [18, 19].
Both hydroxychloroquine and azithromycin are cheap, widely available and with a good safety profile. Hence, the imperative to prove their efficacy to treat COVID-19.
This study will compare three treatment regimens one with hydroxychloroquine (HCQ) in standard dose (HCQs) alone, hydroxychloroquine and azithromycin (AZT) and third with hydroxychloroquine in high dose (HCQh) and determine which regime is the best to treat hospitalised patients with confirmed COVID-19 in armed forces hospitals.
Objectives:
1.To compare efficacy of HCQs versus HCQ + AZT versus HCQh in treatment of COVID-19 among patients admitted to Indian Armed Forces Hospitals.
2.To compare safety of HCQ versus HCQ +AZT versus HCQh alone in treatment of COVID-19 among patients admitted to Indian Armed Forces Hospitals.
AI
References
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Bai Y, Yao L, Wei T et al. Presumed asymptomatic carrier transmission of COVID-19. JAMA 2020 Feb21 (Epub, ahead of print)
You L, Ryan F, Huang M et al. SARS CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med.doi:10.1056/NEJMc2001737
Li R, Pei S,Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial, undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS CoV-2). Science. 2020 doi:10.1126/science.abb3221(2020)
Zhu N, Zhang D, Wang W, Li X. A novel coronavirus from patients with pneumonia in China, 2019. New Eng J Med.2020, Jan 24;382:727-733
Wu Z, McGoogan J Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China.JAMA. 2020Feb24; doi:10.1001/jama.2020.2648
Boudama L, Lescure F-X, Lucet J-C, Yazdanpanah Y, Timsit J-F. Severe SARS-CoV-2 infections: practical considerations and management strategies for intensivists. Intensive Care medicine 2020; 46: 579-582
Wilson N, Kvalsvig A, Barnard L T, Baker M G. Case-fatality risk estimation for COVID-19 calculated using a time lag for fatality. EID. 2020Jun; 26(6). DOI:10.3201/eid2606.200320.
Zhou F, You T, u R, Fan G, Liu Y, Liu Z et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet.2020, Mar11; DOI: https:/doi.org/10.1016/S0140-6736(20)30566-3
10.Onder G, Rezza G, Brusaferro S. Case fatality rate and characteristics of patients dying in relation to OVID-19 in Italy. JAMA. 2020 Mar 23; doi: 10.1001/jama.2020.4683
11.CaoB,WangY,WenD,LiuW,WangJ,FanG,RuanL,SongB,CaiY,WeiM,LiX,XiaJ,ChenN,XiangJ,YuT,Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282. [Epub ahead of print]
12.Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to !ght COVID-19. Int J Antimicrob Agents. 2020 Mar 4:105932. doi: 10.1016/j.ijantimicag.2020.105932. [Epub ahead of print]
13.Yao X,Ye F, Zhang M, Cui C,Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H,Tan W, Liu D.In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of print]
14.Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73].
15.Riou B, Barriot P, Rimailho A, Baud FJ. Treatment of severe chloroquine poisoning. N Engl J Med 1988; 318: 1–6.
16.Ducharme J, Farinotti R. Clinical pharmacokinetics and metabolism of chloroquine. Clin Pharmacokinet 1996;31: 257–74] .
17.Gautret P, Lagier J, Parola P, Hoang V, Meddeb L, Mailhe M, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents. In Press]
18.Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269- 271]
19. Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID19). Drug discoveries & Therapeutics. 2020; 14(1): 58-60
CTRI Number
CTRI/2020/05/025022 [Registered on: 05/05/2020] Trial Registered Prospectively
An open label randomised controlled trial to assess the efficacy of Hydroxychloroquine in patients with mild COVID -19 illness with risk factors for severe disease.
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Manish Soneja
Address
Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND
New Delhi DELHI 110032 India
Phone
9013074717
Fax
Email
manishsoneja@gmail.com
Details Contact Person Scientific Query
Name
Dr Manish Soneja
Address
Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND
New Delhi DELHI 110032 India
Phone
9013074717
Fax
Email
manishsoneja@gmail.com
Details Contact Person Public Query
Name
Dr Manish Soneja
Address
Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND
New Delhi DELHI 110032 India
Phone
9013074717
Fax
Email
manishsoneja@gmail.com
Source of Monetary or Material Support
AIIMS-Department of Medicine
Primary Sponsor
Name
AIIMS Department of Medicine
Address
Department of Medicine
3rd Floor
Teaching Block
AIIMS -Ansari Nagar
HCQ 400 MG BD ON DAY 1 FOLLOWED BY 400 MG OD FOR TOTAL 5 DAYS
Comparator Agent
SYMPTOMATIC TREATMENT
CONTROL GROUP WILL RECEIVE SYMPTOMATIC TREATMENT which includes paracetamol and other drugs according to symptoms.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Patients with RT-PCR confirmed mild COVID-19 illness with high risk factors
2. Age > 18 years
3. Written informed consent
ExclusionCriteria
Details
1. Patients without any of the high risk factors for severe illness
2. Pregnant women
3. Known hypersensitivity to HCQ
4. Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
there are no proven specific antiviral medications available for treatment of COVID-19 . many antivirals are currently undergoing clinical trials.there is extensive experience with HCQ in management of connective tissue disorder. patient with mild illness with risk factors for severe disease who present within 72 hours of illness will be treated with HCQ for 5 days and evaluated for clinical cure on day 7 after symptom onset.
CTRI Number
CTRI/2020/05/025010 [Registered on: 04/05/2020] Trial Registered Prospectively
Last Modified On:
04/05/2020
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Other
Public Title of Study
Hydroxychloroquine prophylaxis in Covid 19 infection
All healthcare workers (including doctors, nurses, and other hospital staff) employed by COVID-19 dedicated hospitals, irrespective of their HCQ consumption status, who test negative at the baseline and consent to be included in the study will be eligible for recruitment in the study
ExclusionCriteria
Details
Healthcare workers who are pregnant or lactating will be excluded based on self-declaration of such status at the baseline evaluation. Those who do not consent to participate will also be excluded. If tested to be COVID-19 positive at baseline, the healthcare worker will be excluded from the study, isolated and managed under standard treatment protocols.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The proportion of healthcare workers who likely contracted COVID-19 infection from a nosocomial source in the 12-week period during which they were under HCQ prophylaxis
Every week for 12 weeks
Secondary Outcome
Outcome
TimePoints
The proportion of healthcare workers who develop adverse drug reactions in the 12-week period during which they were under HCQ prophylaxis
Every week for 12 weeks
Target Sample Size
Total Sample Size="2000" Sample Size from India="2000"
The
current study is being designed as a proof-of-concept, observational study to
establish the effectiveness of a weekly prophylactic regime of
hydroxychloroquine as per ICMR guidelines in prevention of COVID-19 in
healthcare workers in the setting of the COVID-19 epidemic. The objectives are
to estimate incidence rate of SARS-CoV-2 infection as well as side effects
produced among HCWs who were/are undertaking HCQ prophylaxis.
The
study would be conducted in those hospitals which are dedicated to manage
COVID-19 cases. All healthcare workers (including doctors, nurses, paramedical,
lab technicians, sanitary workers and others) irrespective of their HCQ
consumption status, who test negative at the baseline and willing to give
consent will be included in the study. The
study will be done for duration of 12 weeks after the recruitment of the final
participant with expected duration of study is 4 months. Data will be
collected using structured questionnaire which includes exposure history,
symptom history, testing details, Comorbidities, prophylaxis details.
CTRI Number
CTRI/2020/04/024948 [Registered on: 30/04/2020] Trial Registered Prospectively
Last Modified On:
30/04/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical Trial to Study the Effects of Hydroxychloroquine, Ciclesonide and Ivermectin in treatment of moderate COVID-19 illness
Scientific Title of Study
EFFICACY OF HYDROXYCHLOROQUINE, CICLESONIDE AND IVERMECTIN IN TREATMENT OF MODERATE COVID-19 ILLNESS: AN OPEN-LABEL RANDOMISED CONTROLLED STUDY
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Anupam Prakash
Address
Department of Medicine
Lady Hardinge Medical College
Shahid Bhagat Singh Marg
New Delhi
110001
INDIA
New Delhi DELHI 110001 India
Phone
8588885305
Fax
Email
prakashanupam@hotmail.com
Details Contact Person Scientific Query
Name
Anupam Prakash
Address
Department of Medicine
Lady Hardinge Medical College
Shahid Bhagat Singh Marg
New Delhi
110001
INDIA
DELHI 110001 India
Phone
8588885305
Fax
Email
prakashanupam@hotmail.com
Details Contact Person Public Query
Name
Anupam Prakash
Address
Department of Medicine
Lady Hardinge Medical College
Shahid Bhagat Singh Marg
New Delhi
110001
INDIA
Coronavirus as the cause of diseases classified elsewhere
Patients
Other specified viral diseases
Intervention / Comparator Agent
Type
Name
Details
Intervention
Ciclesonide
200 mcg bid for 7 days
Intervention
Hydroxychloroquine
400 mg bid Day1 followed by 200 mg bid on Days 2 to 7
Intervention
Ivermectin
12 mg OD for 7 days
Comparator Agent
Standard of Care
Supportive management as per national guidelines
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
• Adult patients (≥18years) suffering from Covid-19. A positive throat swab (by real time PCR) obtained from a patient suspected to be Covid-19 or from a contact (or HCW) of Covid-19 patient will be considered to be a Covid-19 case.
• Presence of moderate Covid-19 disease (10) as defined by presence of pneumonia (clinical and radiological signs) with respiratory rate between 15 to 30/minute and/or SpO2 90%-94% on room air.
ExclusionCriteria
Details
• Patients with renal or hepatic dysfunction (Serum creatinine > 1.5 mg/dL and serum transaminase levels >120 U/L)
• Patients with clinical heart failure/known CAD
• Known cases of neoplasms or immunodeficiency syndromes
• Patients who are on chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks
• Pregnant and lactating patients
• Uncooperative patients (in the opinion of the investigator, if it is difficult to ensure patient cooperation during the study)
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of patients having virologic cure on Day 6 in each of the groups
Day 6 of treatment initiation
Secondary Outcome
Outcome
TimePoints
o Proportion of patients having resolution of symptoms/signs on Day 7 and Day 14, in each of the groups
o The individual proportion of the aforementioned rescue criteria in each of the groups.
o Side-effects noted in each of the group
Day 7 and Day 14
Target Sample Size
Total Sample Size="120" Sample Size from India="120"
Professor
of Medicine, Lady Hardinge Medical College, New Delhi,
On
behalf of the LHMC Medicine COVID-19 Investigator Group
Place of study:
Department
of Medicine, Lady Hardinge Medical College and associated Hospitals, New Delhi.
Duration of study: May-October
2020
Type
of study: Randomised controlled study.
The
world is facing the crisis created by COVID-19, a pandemic of unassumed
proportions, which does not have any known treatment yet. Several drugs are
being repositioned to see their efficacy for Covid-19. This
study is planned to study the efficacy of oral hydroxychloroquine, inhalational
ciclesonide and oral ivermectin as treatment option in adult patients (≥18
years) with moderate Covid-19 illness.
Moderate Covid-19 illness will
be defined as nasopharyngeal/nasal/oropharyngeal swab positivity by PCR, along
with respiratory rate of 15-30/min and SpO2 between 90-94%. Those fitting the
inclusion and exclusion criteria, will be enrolled after obtaining an informed
written consent, and randomized (by draw of lots) to any of the 4 arms-
(i)Group A - Hydroxychloroquine 400 mg bid oral
Day 1, 200 mg bid on Day 2-7
(ii)Group B –Ciclesonide 200 mcg bid (through
rotahaler) for 7 days
(iii)Group C –Ivermectin 12 mg orally OD for 7 days
(iv)Group D –Standard of care only
A sample size of 30 in each
arm is proposed to be included over a period of 6 months. A focused physical
examination (General appearance and behaviour including mental status, vitals
and chest examination) will be performed for each subject enrolled in the
study. Routine blood and radiological investigations would be performed for
each subject, and an ECG just after admission, and prior to satisfactory
discharge. All patients recruited will anyway receive standard of care, and the
institutional/national management protocol will be followed in all other
respects. Enrolled subjects will be followed up for virologic cure (primary
outcome). Repeat PCR testing on fresh swab would be done on Day 6 onwards and two
consecutive negative throat swabs at least 24 hours apart would constitute
virologic cure (primary outcome). Any positive throat swab on Day 6 onwards,
would entail repeat testing after 48 hours. Trial drug would be continued in
each group (A, B and C) would be continued for a period of 7 days, though
follow-up will be for a period of virologic cure, to a maximum of 14 days.
Trial drug would be withdrawn if they deteriorate to severe Covid-19 illness or
disseminated intravascular coagulation (DIC) or shock. However, they will be
included for the purpose of analysis.
Secondary outcomes include (1) Proportion of
patients having resolution of symptoms/signs on Day 7 and Day 14 in each of the
groups, (ii) Subjects deteriorating in to severe Covid-19 or developing
DIC/shock, (iii) Side-effects observed in each of the group.
The
comparative analysis will be performed using ANOVA testing, and the reporting
would be done as per CONSORT guidelines.
CTRI Number
CTRI/2020/05/024982 [Registered on: 02/05/2020] Trial Registered Prospectively
Effects of using hydroxychloroquine and azithromycin in the treatment of confirmed COVID-19 positive patients
Scientific Title of Study
USAGE OF HYDROXYCHLOROQUINE AND AZITHROMYCIN IN INDICATED CONFIRMED COVID-19 POSITIVE CASES FOR ITS EFFICACY IN EARLY NEGATIVE CONVERSION- PILOT OBSERVATIONAL STUDY AIIMS RAIPUR.
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr PUGAZHENTHAN T
Address
No 2220, IIND FLOOR,DEPARTMENT OF PHARMACOLOGY MEDICAL COLLEGE BUILDING Raipur CHHATTISGARH 492099 India
Phone
9486279090
Fax
Email
drpugal23@gmail.com
Details Contact Person Scientific Query
Name
Dr PUGAZHENTHAN T
Address
No 2220, IIND FLOOR,DEPARTMENT OF PHARMACOLOGY MEDICAL COLLEGE BUILDING
CHHATTISGARH 492099 India
Phone
9486279090
Fax
Email
drpugal23@gmail.com
Details Contact Person Public Query
Name
Dr PUGAZHENTHAN T
Address
No 2220, IIND FLOOR,DEPARTMENT OF PHARMACOLOGY MEDICAL COLLEGE BUILDING
Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
1.00 Day(s)
Age To
70.00 Year(s)
Gender
Both
Details
i) All age group (special: children, all preganant women);
ii) PCR documented SARS-CoV-2 carriage in nasopharyngeal sample at admission whatever their clinical status.
ExclusionCriteria
Details
• Non consented.
• Patients will be excluded if they have a known allergy to hydroxychloroquine /chloroquine and/ or Azithromycin and have any other contraindication to treatment with the study drug(Chloroquine or Azithromycin) including retinopathy, G6PD deficiency and QT prolongation.
• Lactating mothers will be excluded based on their declaration.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
virological clearance
day-6 post-inclusion
Secondary Outcome
Outcome
TimePoints
virological clearance overtime during the study period, clinical follow-up (body temperature, respiratory rate, duration of stay at hospital and mortality), and occurrence of side effects.
28 days
Target Sample Size
Total Sample Size="50" Sample Size from India="50"
Patients
will be seen at baseline for enrolment, initial data collection and treatment
at day-0, and again for daily follow-up upto 6 days. For the secondary outcome
parameter, the samples will be followed up till the negative report (every 48
hours)or untoward outcome till maximum
of 28 days.Each day, patients will
receive a standardized clinical examination and when possible, a nasopharyngeal
and throat samples will be collected. All clinical data will be collected using
standardized questionnaires as per the case record format released by WHO .
All patients in
AIIMS center ( irrespective of clinical severity category) will be proposed
oral hydroxychloroquine sulfate based on the belgian recommendation and revised
guidelines on clinical management of COVID-19, Ministry of Health and family
welfare, MOHFW, Government Of India GOI (EMR Division) dated 31/03/2020 with 400 mg at suspicion/diagnosis;400 mg 12 h later followed by 200 mg BID
upto day 5. Patients who refused the treatment or had an exclusion criteria,
their routiene management data will be interpreted in future if needed (not
as a control). Symptomatic treatment and azithromycin antibiotics as a measure
to prevent bacterial super-infection will be added by investigators as per the
dosage schedule respective of ages and weight based on clinical judgment for
the initial duration of 5 days in both the category of patients. This period
may be extended in case of severe cases as per case to case basis.Hydroxychloroquine and Azithromycin will be
provided by the hospital pharmacy. Since
COVID 19 is an emerging scenario and new information is coming up regularly “the
protocol will be dynamic” enough to serve the patients best interest.
CTRI Number
CTRI/2020/05/025089 [Registered on: 09/05/2020] Trial Registered Prospectively
Last Modified On:
26/07/2023
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Cohort Study
Study Design
Other
Public Title of Study
Effect of Hydroxychloroquine on QTc Interval
Scientific Title of Study
Effect of Hydroxychloroquine Prophylaxis on QTc Interval of Health Care Workers during COVID-19 Pandemic: An Observational Study
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mohan Gurjar
Address
Department of Critical Care Medicine,
SGPGIMS,
Lucknow (UP). 226014
India
Lucknow UTTAR PRADESH 226014 India
Phone
Fax
Email
m.gurjar@rediffmail.com
Details Contact Person Scientific Query
Name
Dr Mohan Gurjar
Address
Department of Critical Care Medicine,
SGPGIMS,
Lucknow (UP). 226014
India
Lucknow UTTAR PRADESH 226014 India
Phone
Fax
Email
m.gurjar@rediffmail.com
Details Contact Person Public Query
Name
Dr Mohan Gurjar
Address
Department of Critical Care Medicine,
SGPGIMS,
Lucknow (UP). 226014
India
Lucknow UTTAR PRADESH 226014 India
Phone
Fax
Email
m.gurjar@rediffmail.com
Source of Monetary or Material Support
Non-funded study.
Primary Sponsor
Name
SGPGIMS
Address
SGPGIMS, Raebareli Road,
Lucknow (UP)
226014
India
Health Care Workers taking Hydroxychloroquine chemoprophylaxis as recommended by Indian Council of Medical Research (ICMR) during care of COVID-19 confirmed cases
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
All HCWs who have been advised for HCQ as prophylaxis during their posting to manage COVID-19 confirmed or suspected patients.
ExclusionCriteria
Details
Not on HCQ prophylaxis.
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
Change in QTc interval
Before and after HCQ prophylaxis
Secondary Outcome
Outcome
TimePoints
Baseline QTc interval
Before HCQ prophylaxis
Target Sample Size
Total Sample Size="50" Sample Size from India="50"
Gutte, Shreyas; Gurjar, Mohan; Sanjeev, Om Prakash1; Bhadauria, Dharmendra2; Kapoor, Aditya3; Mishra, Prabhaker4; Azim, Afzal; Poddar, Banani. QTc Interval of Healthcare Workers from India: Baseline and Effect of Hydroxychloroquine Prophylaxis during the COVID-19 Pandemic. Indian Journal of Community Medicine 48(3):p 497-500, May–Jun 2023. | DOI: 10.4103/ijcm.ijcm_663_22. PMID: 37469913
Brief Summary
Hydroxychloroquine (HCQ) has been found to be effective against Corona Virus Disease 2019 (COVID-19) in laboratory studies and it is now recommended as chemoprophylaxis for healthcare workers (HCW) involved in the care of suspected or confirmed cases of COVID-19, by Indian Council of Medical Research (ICMR). HCQ potentially can cause QT interval prolongation in electrocardiogram (ECG). There is no systematic study so far in HCW regarding HCQ in context of this recent COVID-19 pandemic. This is a prospective observational study to know the effect of HCQ, as prescribed for prophylaxis for HCW during COVID-19 pandemic, on the QTc interval in the ECG.
CTRI Number
CTRI/2020/05/025289 [Registered on: 21/05/2020] Trial Registered Prospectively
Last Modified On:
20/05/2020
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Other
Public Title of Study
An observational study on QT interval changes with Hydroxychloroquine used as prophylaxis in COVID exposure risk individuals
Scientific Title of Study
An observational study on Hydroxychloroquine used as prophylaxis for high COVID exposure risk individuals with special reference to QT interval
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
P Vamsavardhana Reddy
Address
Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield P Vamsavardhana Reddy Assistant Professor Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield 560066 Bangalore KARNATAKA 560066 India
Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield P Vamsavardhana Reddy Assistant Professor Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield 560066 Bangalore KARNATAKA 560066 India
Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield P Vamsavardhana Reddy Assistant Professor Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield 560066 Bangalore KARNATAKA 560066 India
Department of Cardiology VIMS and RC EPIP area Nallurhalli Whitefield Bengaluru Karnataka 560066
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Contact Person
Name of Site
Site Address
Phone/Fax/Email
P Vamsavardhana Reddy
Bangalore
ASIAN LAASYA APARTMENT
FLAT NO G-11 NALLURA HALLI
BOREWELL ROAD WHITE FIELD 560066 Bangalore
9686316728
vamsareddy4403@vimsmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Vydehi Institutional Ethics Committee (VIEC)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
After taking written and informed consent, we do clinical follow up for 7 weeks and observe the ECG those who are taking Hydroxychloroquine tablet voluntarily or prescribed by any other physician.
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
All High COVID exposure risk individuals aged above 18 years & weight > 35 kg consuming Hydroxychloroquine as prophylaxis for COVID-19
ExclusionCriteria
Details
Individuals not willing to participate in the study
Hydroxychloroquine (HCQ) is an approved drug for various indications like Malaria, Rheumatoid Arthritis and Systemic Lupus Erythematosus by the Indian drug regulatory authority. HCQ believed to act on the entry and post-entry stages of SARS-CoV and SARS-CoV-2 infection and recently, FDA has issued an Emergency Use Authorization (EUA) for the treatment and prophylaxis for Covid-19 risk group. Hence ICMR has recommended HCQ as prophylaxis for all asymptomatic high COVID exposure risk with the dosage of 400 mg BD on day 1, followed by 400 mg once weekly for next 7 weeks; to be taken with meals. The primary objective of the study is to determine the frequency/Incidence & magnitude of prolongation of heart rate corrected QT (QTc) in high COVID exposure risk individuals.
It is a Prospective Observational study including clinical follow up for 7 weeks. We plan to enroll high COVID exposure risk individuals, taking Hydroxychloroquine as per ICMR recommended doses voluntarily or on advice of some other physician, not participating in this study. All such individuals who are beginning to take HCQ or have started the course within preceding one week and have one baseline ECG will be eligible for inclusion. If there is any QTc interval change during the study period, we will advise to consult the primary physician/ cardiologist who prescribed the HCQ immediately. LFT, RFT, Serum electrolytes, Serum calcium & S. magnesium will be taken to rule out secondary causes in those who have QTc prolongation. All the 3 ECG’s recorded by using the same machine (software) for all the study groups as much as possible and the QTc interval measured manually by using the Bazett’s formula [QT / sqr (R-R interval)].
CTRI Number
CTRI/2020/06/025593 [Registered on: 04/06/2020] Trial Registered Prospectively
Last Modified On:
03/06/2020
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Cross Sectional Study
Study Design
Other
Public Title of Study
A study to determine relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigation
Scientific Title of Study
“Relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigation: a pragmatic prospective observational study (RE-HCP2 COVID study)”
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Prasan Kumar Panda
Address
Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh
Dehradun UTTARANCHAL 249203 India
Phone
9868999488
Fax
Email
prasan.med@aiimsrishiekesh.edu.in
Details Contact Person Scientific Query
Name
Prasan Kumar Panda
Address
Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh
UTTARANCHAL 249203 India
Phone
9868999488
Fax
Email
prasan.med@aiimsrishiekesh.edu.in
Details Contact Person Public Query
Name
Prasan Kumar Panda
Address
Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh
Research cell, AIIMS, Rishikesh, Uttarakhand, 249203
Primary Sponsor
Name
AIIMS Rishikesh
Address
Research cell, AIIMS, Rishikesh, Uttarakhand, 249203
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NILL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Contact Person
Name of Site
Site Address
Phone/Fax/Email
Dr Prasan Kumar Panda
AIIMS
Department of General Medicine, Sixth floor, College Block, AIIMS Rishikesh Dehradun
9868999488
prasan.med@aiimsrishiekesh.edu.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
IEC, AIIMS Rishikesh
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
healthcare-professionals
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Any Asymptomatic Medical professional (MP) of either sex (including pregnant and lactating female), >18 years of age and > 45 kg of weight, based in a primary, secondary or tertiary healthcare setting, who is already taking or willing to take chloroquine prophylaxis in anticipation of high risk of developing COVID-19 due to his/her potential exposure to patients with SARS-CoV-2 infection or having risk of this infection.
2.Special inclusion of MPs for case control arm will be:
a.Those who are reluctant to take any prophylaxis
b.MP with history of the following conditions: Retinopathy or retinal disease; Cardiomyopathy; Cardiac arrhythmia; Prolonged QTc; Psoriasis; Porphyria cutanea tarda; Epilepsy; Myasthenia gravis; Myopathy of any cause; Serious hepatic or renal disease; Glucose-6-phosphate dehydrogenase deficiency (G6PD); Severe depression which prevent chloroquine use
c.Self-reported current use of medication with known serious hepatotoxic effects or known interaction with chloroquine/ hydroxychloroquine as listed in appendix 3 which prevent chloroquine use.
ExclusionCriteria
Details
1.Weight outside range 45 kg – 150 kg (99 lbs – 330 lbs).
2.Prior enrolment into this observational study.
3.Self-reported or diagnosed infection with SARS-CoV-2 or previous COVID-19 diagnosis within the last 6 months.
4.Self-reported current acute respiratory infection
5.Inability or unwillingness to be followed up for the trial period
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
(1) Incidence of Symptomatic COVID-19 in each one of 4 arms;
Clinical diagnosis of COVID-19 with virology confirmation, with limitation of activities (WHO Severity Scale 2-8) over the study enrolment period.
(2) Incidence of Peak severity of COVID-19 over the study period in COVID-19 positive MPs
(1)The incidence of: pneumonia; respiratory failure requiring intubation; acute respiratory distress syndrome; delirium; shock requiring vasopressor medications; sepsis; acute kidney injury; acute liver injury; death. Case definitions will be decided a priori.
(2)Duration of intensive care unit stay, hospital day.
(3)Population pharmacokinetic evaluation based on sparse sampling methodology if possible.
30days
Target Sample Size
Total Sample Size="3000" Sample Size from India="3000"
Phase of Trial
N/A
Date of First Enrollment (India)
12/06/2020
Date of First Enrollment (Global)
No Date Specified
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nil
Brief Summary
An effective and safe prophylaxis or mitigation therapy could change the complexion of COVID-19, altering the extent and severity of infection, and buying time for production of effective vaccines.
CTRI Number
CTRI/2020/06/025849 [Registered on: 12/06/2020] Trial Registered Prospectively
Last Modified On:
14/06/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study to Evaluate the Safety and Efficacy of a Combination of Nitazoxanide and Hydroxychloroquine Versus Hydroxychloroquine Alone in COVID-19 Patients
Scientific Title of Study
A Randomized, Open Label, 2-Treatment Groups Clinical Trial Evaluating the Safety and Efficacy of a Combination of Nitazoxanide and Hydroxychloroquine Versus Hydroxychloroquine Alone in the Acute Treatment of Moderate COVID-19 Patients
Institutional Clinical Ethics Committee, RGMC and Chatrapati Shivaji Maharaj Hospital
Approved
Institutional Ethics Committee (IEC-GMCA)
Approved
Institutional Ethics Committee Hindu Mission Hospital
Approved
Institutional Ethics Committee Masina Hospital
Approved
Institutional Ethics Committee, Govt. Medical College, Nagpur
Approved
Institutional Ethics Committee, Sai Sneh Hospital and Diagnostic Centre
Approved
Navsanjeevani Hospital Ethics Committee
Approved
Rhythm Heart Institute Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent
Type
Name
Details
Intervention
Hydroxychloroquine
600 mg QD (on Days 1 and 2) followed by 200 mg BID (on Days 3 to 14)
Intervention
Nitazoxanide and Hydroxychloroquine
Nitazoxanide: 1000 mg QD (on Days 1 and 2) followed by 500 mg BID (on Days 3 to 14) + Hydroxychloroquine: 600 mg QD (on Days 1 and 2) followed by 200 mg BID (on Days 3 to 14)
2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab
Note: A re-treated/ relapsed patient may be enrolled if he/she meets all of the following criteria:
a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment
AND
b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated
AND
c. Patient meet the below-mentioned criterion (# 3) for ‘moderate’ COVID-19 disease severity
3. Patients clinically assigned as ‘moderate’ (Pneumonia with no signs of severe disease, respiratory rate ≥24 breaths/minute, SpO2 <94% (90%-94%) on room air)
Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV).
4. Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment
5. Able and willing to provide informed consent
6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator
7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
ExclusionCriteria
Details
1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide
2. Patients with history of or one or more known comorbidities at baseline:
a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure
b. Uncontrolled Diabetes Mellitus
Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications.
c. COPD, Asthma or Interstitial Lung Disease
d. Malignancy
e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
f. G6PD deficiency
g. Psoriasis or porphyria
h. Kidney Disease (Serum creatinine > 1.5 times upper limit)
i. Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase) >3.5 times upper limit)
j. Cardiac conduction delay (QTc > 500 msec)
k. Retinopathy or macular degeneration
3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients).
4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit
5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit.
6. Patients clinically assigned as having ‘severe’ COVID-19 disease (Severe Pneumonia (with respiratory rate ≥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization
Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV).
7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients
8. Inability to take oral medication.
9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption
10. Current smoker or has quit smoking within last 3 months
11. Body Weight < 45 kg
12. Female patients who are pregnant or lactating
13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.)
14. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment
15. Patients who are not suitable to participate in the study based on the Investigator’s judgement
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change from baseline in mean viral load (determined by rRT-PCR on a nasopharyngeal/ oropharyngeal swab)
Day 14 or at discharge from hospital, whichever is earlier
Secondary Outcome
Outcome
TimePoints
Change from baseline in mean viral load (determined by rRT-PCR on nasopharyngeal/ oropharyngeal swab)
Days 3, 7 and 10
Changes of parameters at each assessment during the study/follow-up period, compared to baseline for:
▪ Vital signs: body temperature, heart rate, respiratory rate, systolic/diastolic blood pressure and oxygen saturation.
▪ Clinical Laboratory assessments: hematology, serum chemistry, urinalysis.
▪ 12-lead ECG: Changes in heart rate, PR, QRS, QT and QTcB intervals
Day 1 to Day 14
Mean change from baseline in National Early Warning Score 2 (NEWS-2) score
Days 3, 7, 10 and 14
Mean change from baseline in patient’s clinical status on a 10-point ordinal scale (SOLIDARITY trial).
Days 3, 7, 10 and 14
Mean/ median time (no. of days) the patient is:
a. Managed in intensive care unit
b. On Oxygen supplementation
c. On Invasive mechanical ventilation
Day 1 to Day 14
Mean/median time (no. of days) from start of treatment to discharge from hospital
Day 1 until discharge from hospital
Mean/median time (no. of days) to
a. Management in intensive care unit
b. Oxygen supplementation
c. Invasive mechanical ventilation
Day 1 to Day 14
Median time (no. of days) to negative conversion (of detectable SARS-CoV-2 viral RNA) on nasopharyngeal swab
From Day 1 of treatment to negative conversion
Number (and percentage) of patients reporting treatment emergent adverse events (TEAEs)
Day 1 to Day 14
Percentage of patients discharged from ‘isolation ward’ of COVID-management hospital facility
Day 1 to Day 14
Percentage of patients dying due to COVID-19 complication
Day 1 to Day 14
Percentage of patients requiring of treatment:
a. Management in intensive care unit (ICU)
b. Oxygen supplementation
c. Invasive mechanical ventilation
Day 1 to Day 14
Percentage of patients showing negative conversion (of detectable SARS-CoV-2 viral RNA) on nasopharyngeal/oropharyngeal swab
Day 14
Time to achieve symptom improvement of at least 30% in the COVID-19 symptoms sum score
Day 1 to Day 14
Target Sample Size
Total Sample Size="158" Sample Size from India="158"
COVID-19 is currently a major global public health crisis and in the absence of an effective vaccine and ‘herd’ immunity, there are no known interventions for effectively dealing with this pandemic (other than broad public-health measures like physical distancing and containment). At an individual COVID-19 patient level, there is a lack of proven specific treatment options that improve symptoms, influence disease severity progression and outcomes or aid the treating physician in better patient management. Different medicines and medicinal systems are being explored to find remedial measures for this new infection. Antiviral drugs, and other antimicrobial agents are being evaluated and being utilized off-label in treating patients, largely those with more severe COVID-19. However, no breakthrough has been achieved to date either in curtailing the pandemic or improving patient outcomes.
Hydroxychloroquine has had mixed outcomes in the treatment of COVID-19. Gautret et al, 202014 has shown the efficacy of Hydroxychloroquine when compared with the control group; other observational studies17, 18 have not shown convincing benefit to risk ratio however, these were non-randomized. It is already being used off-label for the treatment of COVID-19 in many countries, including India and the United States.
The other drugs namely, Nitazoxanide has been reported to have broad antiviral properties, in addition to antiparasitic properties for which it is approved. Nitazoxanide is currently approved in India (for Giardia lamblia and Crytosporidium parvum infections) and has been in use since many years with no major safety concerns.
In this study, we are also evaluating a combination regimen of Hydroxychloroquine and Nitazoxanide in comparison to a regimen of Hydroxychloroquine alone in treating patients assessed to have COVID-19 disease of moderate severity, to see if treatment of COVID-19 could be further optimized in terms of efficacy and safety.
CTRI Number
CTRI/2021/02/031430 [Registered on: 22/02/2021] Trial Registered Prospectively
Efficacy of Remdesevir and Hydroxychloroquine in moderate to severe COVID-19 patients admitted in the CCU of a tertiary care hospital in WestBengal,India.
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
SWATI DUTTA
Address
88, College Street 88, COLLEGE STREET
KOLKATA
700073 Kolkata WEST BENGAL 700073 India
Another group will receive Hydroxychloroquine 400 mg orally twice daily on day 1 followed by 200 mg orally once daily day 2-5
Intervention
Remdesevir
One group will receive Remdesevir 200 mg iv day 1 followed by 100 mg iv day 2-5
Inclusion Criteria
Age From
12.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
COVID RTPCR POSITIVE CASES
PNEUNONITIS AS EFIDENT FROM CXR, HRCT THORAX
REQUIRING OXYGEN VIA NRBM OR HIGHER SUPPORT LIKE HFNO,NIV OR INVASIVE VENTILATION
ExclusionCriteria
Details
H/O DRUG ALLERGY TO ANY OF THE STUDY DRUGS
H/O ADVERSE DRUG REACTION TO ANY OF THE STUDY DRUGS
ELEVATED LIVER ENZYMES
H/O OCCULAR DISEASE
H/O CARDIO VASCULAR CONDUCTION DISEASE
A comparative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL)in treatment of Lateral Epicondylitis (Tennis Elbow)
Scientific Title of Study
A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
Subjects will receive one injection of HPL (5mL) in the lateral epicondyle space
Comparator Agent
Corticosteroid
Subjects will receive one injection of corticosteroid in the lateral epicondyle space
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Subjects with clinical diagnosis of tennis elbow within the last 3 months
2. Subjects both male and female, aged 18-60 years (both inclusive)
3. Subjects who are willing to give informed consent and adhere to the study protocol
ExclusionCriteria
Details
1. Subjects aged less than 18 and more than 60 years
2. Subjects with autoimmune diseases
3. Subjects with immuno-compromised system
4. Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
5. Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
6. Subjects who have received treatment with corticosteroid injections within the last 6 months
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score: To evaluate the effect of HPL on Pain Scores.
2. The American Shoulder and Elbow Society score – To evaluate the effect of HPL on pain, function, range of motion, strength and patient satisfaction on various numerical scales.
3. All the above questionnaires are externally validated clinical outcome measures that rate elbow pain
End of study - 3 Months
Secondary Outcome
Outcome
TimePoints
Ultrasonography
End of study - 3 Months
Target Sample Size
Total Sample Size="20" Sample Size from India="20"
This is a multicentre, open
label, randomized, pilot study to evaluate safety and efficacy of human
Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in
India. The primary end points are Visual Analog Score
(VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary
endpoint is improvement in ultrasonography form randomization to End of study.
