Cases of COVID 19 shall be
treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with
standard treatment of the hospital protocol
Comparator Agent
Standard treatment as per hospital protocol for COVID 19
Cases of
COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19 until the recovery.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Subjects within age group between 18 to 75 years
2. With either sex, male or female
3. Confirmed case of COVID-19 at Max Hospitals.
This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19
then to explore its potential use in the combating to the COVID 19 pandemics.
Viral load will be monitored at 1, 3 & 5 days from beginning of trial drug (48 hours interval) Until the report comes negative. Drug will be delivered on daily basis upto eradication of virus or completion of
the trial
Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease
causes respiratory illness (like the flu) with symptoms such as a cough, fever, and in more
severe cases, difficulty breathing. At present, there are no specific treatments for COVID-19.
WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir,
Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently,
there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly report here that Ivermectin, an FDA-approved anti-parasitic previously
shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus
(SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect ∼5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study
rationale is to understand the effect of the drug on eradication of virus. This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19
then to explore its potential use in the combating to the COVID 19 pandemics.
Enrollment of subject into the trial shall only occur after providing written permission to
voluntarily participate into the study by signing and dating the informed consent form before
starting any trial related treatment. 50 cases of COVID-19 will be enrolled into the trial. The trial
shall be divided into two groups. First group with 25 confirmed cases of COVID 19 shall be
treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with
standard treatment of the hospital protocol. The second group with 25 confirmed cases of
COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19.
Subjects in both the arms shall be followed up for recovery of death with regular monitoring as
per below schedule.
Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the
hospital
Clinical profile of the patient every day of hospitalization
Investigation of pulmonary function and O2 saturation every day of hospitalization
The day a patient is put on ventilator and the day when removed
The day a patient develops acute respiratory distress syndrome and the day when
relieved
All the above data shall be collected on paper case record form for interim and final analysis
from start of the trial i.e enrolment, treatment and follow-up.
Viral test to monitor the eradication of Virus shall be done free of cost from third day of
enrollment and providing the study drug on daily basis upto eradication of virus or completion of
the trial.
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/2020/05/025068 [Registered on: 07/05/2020] Trial Registered Prospectively
Last Modified On:
07/05/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Can a medicine help in curing viral infection
Scientific Title of Study
A Phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Biju George
Address
Department of Haematology,
First Floor, Room no-3,
Christian Medical College
Vellore TAMIL NADU 632004 India
Phone
04162282352
Fax
04162226449
Email
biju@cmcvellore.ac.in
Details Contact Person Scientific Query
Name
Biju George
Address
Department of Haematology,
First Floor, Room no-3,
Christian Medical College Department of Haematology,
First Floor, Room no-3,
Christian Medical College
TAMIL NADU 632004 India
Phone
04162282352
Fax
04162226449
Email
biju@cmcvellore.ac.in
Details Contact Person Public Query
Name
Biju George
Address
Department of Haematology,
First Floor, Room no-3,
Christian Medical College Department of Haematology,
First Floor, Room no-3,
Christian Medical College
The doses are as follows (based on body weight)
15 - 24 kg: 3 mg PO once
25 - 35 kg: 6 mg PO once
36 - 50 kg: 9 mg PO once
51 - 65 kg: 12 mg PO once
66 - 79 kg: 15 mg PO once
80 kg and 15 kg: 200 ug/kg PO once
Comparator Agent
patients will receive the standard protocol for management of COVID 19 infection.
patients will receive the standard protocol for management of COVID 19 infection.
Inclusion Criteria
Age From
1.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Confirmed diagnosis of COVID19 infection based on +ve RTPCR
ExclusionCriteria
Details
Patients with other viral infections
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To study if Ivermectin can reduce the viral load in patients with hematological illnesses who are admitted with COVD19 infection
Day 7
Secondary Outcome
Outcome
TimePoints
To study the factors that affect viral load reduction
To study if the reduction in viral load correlates with improvement in inflammatory parameters
To study the incidence of serious adverse events and safety of this drug when used in hematological illnesses
Day 7
Day 20
Target Sample Size
Total Sample Size="50" Sample Size from India="50"
We will plan to publish the results of this study in reputed National and International Journals.
Brief Summary
Corona virus disease 2019, a recently declared pandemic by the World Health Organization, is associated with a mortality ranging from 1-5% in immunocompetent individuals and will probably results in higher mortality in immunosuppressed patients. One of the important factors affecting outcomes including morality and ICU admission has been the viral load at the onset of disease and the rate of viral clearance. There are no standard drugs that are of proven benefit against the COVID 19 virus and majority of the treatment has been supportive. Recent data has suggested that ivermectin, an antiparasitic drug, is able to cause a 5000 fold reduction in viral RNA at 48 hours post exposure in cell lines. Ivermectin is a very safe drug to use in immunosuppressed patients for treatment of parasitic infections and has a good safety and tolerability profile.
In this study, we would like to randomize patients into 2 groups – group A will get the standard treatment protocol for COVID 19 infection as per institutional protocols and Group B will receive the standard treatment along with Ivermectin given on day 1 and Day 8. Baseline samples will be collected to look for presence of cytopenia, coagulopathy and also status of the immune system. The PCR samples will be stored for quantification of the viral load at a later point of time. PCR samples will be repeated on alternate days starting on Day 1 followed by 3, 5, 7, 10 and 14 and then at weekly intervals till discharge/death. All patients will be followed till recovery from illness or death. Blood parameters that are abnormal will be repeated twice a week till discharge. We will study whether there is a rapid clearance of the virus with the use of ivermectin and whether that has led to better outcomes.
Results and Conclusion:
We will be able to study if ivermectin reduces the viral load and whether this reduction will lead to stabilization of disease and clinical findings including the inflammatory parameters.
CTRI Number
CTRI/2020/05/025224 [Registered on: 18/05/2020] Trial Registered Prospectively
Last Modified On:
16/05/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study to efficacy of Ivermectin in patients of COVID-19
Scientific Title of Study
Interventional study to assess the efficacy of Ivermectin with standard of care treatment versus standard of care in patients of COVID-19 at R D Gardi Medical College, Ujjain, India
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sunil Rathi
Address
3rd Floor, Department of Pediatrics R D Gardi Medical College Agar Road, Surasa Ujjain MADHYA PRADESH 456006 India
1. Adults (age ≥18 years to ≤75 years) 2. Laboratory-confirmed SARS-CoV-2 infection and, in the view of the responsible doctor, no contra-indication to any of the study treatments 3. Hospitalized at R D Gardi Medical College, Ujjain Madhya Pradesh
ExclusionCriteria
Details
1. Anticipated transfer to another hospital, within 72 hours, which is not a study site 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection
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
Effect of Ivermectin on eradication of virus.
Test for virus at 1, 3 and 5 days from beginning of trial drug started for the patient in the hospital
3 months
Secondary Outcome
Outcome
TimePoints
1. Overall safety of the study drug
2. Duration of hospitalization
3. Improvement in the abnormal laboratory values
3 months
Target Sample Size
Total Sample Size="50" Sample Size from India="50"
Results will be published in relevant open access peer-reviewed scientific journals.
Brief Summary
The aim of this study is to validate the antivirus
effectiveness of Ivermectin on coronavirus i.e COVID 19 and study its
effectiveness in combating COVID 19 pandemics.
At present, there are no specific treatments for
COVID-19. Ivermectin, an FDA-approved anti-parasitic previously shown to have
broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative
virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post
infection with SARSCoV-2 able to affect about 5000-fold reduction in viral RNA
at 48 h. Ivermectin is a CDSCO approved drug. However, it requires further
investigation for possible benefits COVID-19 patients and further eradication
of COVID-19 virus.
CTRI Number
CTRI/2020/05/025333 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On:
22/05/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study to assess efficacy of Ivermectin as prophylaxis of COVID -19
Scientific Title of Study
Study to assess the efficacy of Ivermectin as prophylaxis of COVID 19 among health care workers and COVID 19 contacts in Ujjain, India
Secondary IDs if Any
Secondary ID
Registry
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sunil Rathi
Address
3rd Floor, Department of Pediatrics
C R Gardi Hospital
R D Gardi Medical College
Agar Road, Surasa
Ujjain MADHYA PRADESH 456006 India
Phone
9425093116
Fax
Email
sunil.k.rathi.59@gmail.com
Details Contact Person Scientific Query
Name
Dr Ashish Pathak
Address
3rd Floor, Department of Pediatrics
C R Gardi Hospital
R D Gardi Medical College
Agar Road, Surasa
Ujjain MADHYA PRADESH 456006 India
Phone
9302239899
Fax
Email
drashish.jpathak@gmail.com
Details Contact Person Public Query
Name
Dr Ashish Pathak
Address
3rd Floor, Department of Pediatrics
C R Gardi Hospital
R D Gardi Medical College
Agar Road, Surasa
Outcome indicators are :
1. Resolution of sign and symptoms of COVID 19
2. Negative RTPCR done 48 hours after Ivermectin dose
OR
Change /reduction in CT value as reported in RTPCR for SARS-COV-2 virus assay.
Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form.
Secondary outcome indicators: No adverse event after administration of the drug. Adverse events will be systematically recorded and notified to institutional ethics committee
Lab values : CT value of RTPCR as reported in primary outcome.
7 Days
Target Sample Size
Total Sample Size="2000" Sample Size from India="2000"
Results will be published in relevant open access peer-reviewed scientific journals.
Brief Summary
This aims of this study is to validate the antivirus
effectiveness of Ivermectin as prophylaxis in combating COVID 19 pandemics.
At present, there are no specific treatments for
COVID-19. Ivermectin, an FDA-approved anti-parasitic previously shown to have
broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative
virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post
infection with SARSCoV-2 able to affect about 5000-fold reduction in viral RNA
at 48 h. Ivermectin is a CDSCO approved drug.
