| CTRI Number |
CTRI/2021/05/033791 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
26/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial Evaluating Niclosamide for the Treatment of Covid-19 Disease. |
|
Scientific Title of Study
|
A Multicentric Phase II Randomized Open Label Clinical Study to Evaluate Efficacy Safety and Tolerability of Niclosamide for the Treatment of Hospitalized Corona Virus Disease (COVID-19) Patients |
| Trial Acronym |
NICOVID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICS/LAX/2020-006 Version 3.0 Dated 28 Mar 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R M Chhabra |
| Designation |
Medical Monitor/Trial Coordinator |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
Not Applicable
North West
DELHI
110034
India |
| Phone |
011-49049115 |
| Fax |
011-49049115 |
| Email |
Chhabradrrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R M Chhabra |
| Designation |
Medical Monitor/Trial Coordinator |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
Not Applicable
North West
DELHI
110034
India |
| Phone |
011-49049115 |
| Fax |
011-49049115 |
| Email |
Chhabradrrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R M Chhabra |
| Designation |
Medical Monitor/Trial Coordinator |
| Affiliation |
Insignia Clinical Services Pvt. Ltd. |
| Address |
Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India
Not Applicable
North West
DELHI
110034
India |
| Phone |
011-49049115 |
| Fax |
011-49049115 |
| Email |
Chhabradrrm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Laxai Life Sciences Pvt. Ltd. Third Floor, Ventureast Plaza, Plot # 40 & 41, Road No. 02, Financial District, Nanakramguda, Ranga Reddy District, Telangana 500032 India |
|
|
Primary Sponsor
|
| Name |
Laxai Life Sciences Pvt Ltd |
| Address |
Third Floor, Ventureast Plaza, Plot # 40 & 41, Road No. 02, Financial District, Nanakramguda, Ranga Reddy District, Telangana 500032 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Council Of Scientific And Industrial Research Indian Institute Of Chemical Technology CSIRIICT |
Uppal Road, IICT Colony, Tamaka, Hyderabad, Telangana 500007 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Thumjaa |
Aarupadai Veedu Medical College and Hospital |
Ground Floor, Department of Paediatrics, Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Puducherry- 607403
Pondicherry
PONDICHERRY |
914132615246
thumjaa@gmail.com |
| Dr B L Shashi Bhushan |
Bangalore Medical College and Research Institute |
Room No 50 B Block Department of Pulmonary Medicine Victoria Hospital Fort KR Road
Bangalore
KARNATAKA |
080-26701150
ShashiBhushanBL@Yahoo.com |
| Dr Aneesh Raj |
Noorul Islam Institute of Medical Science (NIMS) and Research Foundation |
Covid Care Center, Aush Block , NIMS Medicity, Aralummoodu P.O. Neyyattinkara, Trivandrum, Kerala-695123
Thiruvananthapuram
KERALA |
04712222115
draneeshraj@gmail.com |
| Dr Pravin Soni |
PCMCs PGI Yashwant Rao Chavan Memorial Hospital |
Covid Blocks 64A Ground Floor and 111 First Floor PCMCs PGI Yashwant Rao Chavan Memorial Hospital
Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
020-67332200
020-67332200
DrPravinSoni18@Gmail.com |
| Dr Vijaykumar Barge |
RCSM Government Medical College and CPR Hospital |
Room 01, Department of Medicine, Dasara Chowk, Bhausingji Road, Town Hall, Kolhapur 416012
Kolhapur
MAHARASHTRA |
0231-2644233
0231-2644233
DrVijayBarge12@Gmail.com |
| Dr Ashok Kumar |
Santosh Medical College Hospital |
First Floor, Department of General Medicine, Santosh Medical College Hospital #1, Ambedkar Road Ghaziabad, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
Ghaziabad
UTTAR PRADESH |
0120-2741141
0120-2741141
SMCHGZB@Gmail.com |
| Dr Vishal Gupta |
SMS Medical College & Attached Hospital |
Room # 04, PRT Wing, Dhanwantri Block, SMS Medical College & Attached Hospital
Jaipur
RAJASTHAN |
020-67332222
DrVishalGuptaMD@Rediffmail.com |
| Dr Changalva Premdeep |
Vijaya Super Speciality Hospital |
Ground Floor, Room No. 7 Department of Pulmonology, Vijaya Super Speciality Hospital, 16-II/41 A Raghava Cine Complex Road, Pogathota, Nellore, Andhra Pradesh-524001, India
Nellore
ANDHRA PRADESH |
08612321828
dr.premdeep88@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College & Research Institute |
Approved |
| Ethics Committee SMS Medical College Jaipur |
Approved |
| Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital, Pimpri, Pune, Maharashtra |
Approved |
| Institutional Human Ethical Committee Aarupadai Veedu Medical College and Hospital |
Approved |
| NIMS IEC |
Approved |
| Rajarshee Chhatarpati Shahu Maharaj Govt Medical College and Chhatarpati Pramila Raje Hospital, Kolhapur Institutional Ethics Committee 2 |
Approved |
| Society for Academic, Scientific & Translational Research Advancement |
Approved |
| Society for Academic, Scientific & Translational Research Advancement |
Approved |
| Vijaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Niclosamide 2000 mg orally Plus Standard of Care |
Niclosamide 2000 mg orally Plus Standard of Care
Treatment Duration for 07 Days |
| Comparator Agent |
Standard Of Care |
Standard Of Care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized, or practicing a reliable
method of birth control during the duration of the study) patients with ages ranging from 18 to 65 years (both inclusive).
Clinically stable condition for at least 6 months before enrollment.
Confirmed diagnosis of moderate COVID-19 symptoms demonstrated by:
Positivity in RT-PCR 2019-nCov test on respiratory tract (nasopharyngeal / oropharyngeal) specimens.
Presence of dyspnea and/or hypoxia, fever, cough, including SpO2 < 93% (range 90-93%) on room air, Respiratory Rate > 24 and < 30 breaths per minute. Patients with SpO2 < 90% to be excluded from the study.
Signs of pneumonia (lung injury/lung involvement) confirmed by Chest X-Ray at the time of study entry.
Disease severity score between Grade 4 to 5 on the WHO 9-point ordinal scale & patient requires
hospitalization for management of the disease.
Within 7 days from symptom onset or within 72 hours of laboratory diagnosis of SARS-CoV2 via RT-PCR test.
Able to take oral tablets at the time of study entry and agree not to participate in any other study for
duration of participation in this study.
Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent then the same should be obtained from a legally acceptable representative (LAR).
|
|
| ExclusionCriteria |
| Details |
Subjects will be excluded from the study for any of the following reasons:
Subjects with known allergy or hypersensitivity to Niclosamide or any of its components.
Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale.
Evidence of severe or critical illness, defined by at least 1 of the following:
Respiratory failure requiring at least 1 of the following:
Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure
Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors),
OR
Multi-organ dysfunction/failure
Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR<30ml/min).
Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN].
Subjects with oxygen saturation (SpO2) ≤90%.
Respiration Rate ≥30 breaths per minute at the time of enrolment.
History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications.
Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug).
Patients who require IL-6 inhibitors for management of inflammation at the time of study entry.
Female subjects who are pregnant or involved in breastfeeding.
Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry.
Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
Has a history of alcohol or drug abuse in the previous 6 months.
Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year.
Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis.
Hospital discharge is anticipated in ≤24 hours.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Participated in any other clinical trial or taken an investigational drug within 1 month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to Clinical Improvement of 2-points on WHO 8-Point Ordinal Scale
|
Baseline, Day 03, Day 05, Day 07, Day 14, Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome measures for this study will include:
Time to respiratory viral clearance
Improvement in lung injury on Chest X-Ray
Other outcome measures for this study will include:
All-cause mortality
|
Time frame : 3, 7, 10, 14 days
Time frame: Baseline, 14, 21 days
Time frame: 21 days
|
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Phase II, Randomized, Multi-centric, Open Label clinical study to evaluate the efficacy, safety & tolerability of Niclosamide when used alongside Standard of Care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19). The proposed study is a two phase clinical study wherein first phase, i.e, Treatment Phase will began when either a male or female (non-pregnant, non-lactating) patients between 18 to 65 years (both inclusive) with clinically confirmed & documented diagnosis of moderate coronavirus disease (COVID-19) with severity rating of Grade 4 or Grade 5 at the time of study entry as per WHO ordinal score and who require hospitalization for management of the disease will be screened and enrolled for participation in the study as per study protocol. The treatment period with investigational product in test group will be 7 days. It is however necessary that all patients in either test or control groups be allowed to take concomitant SOC as per the prescribed schedule for entire duration of the study, as applicable. Follow-up Phase shall begin from EOT (Day 8) and will continue for another 2 weeks for each patient. During Follow-up Phase, all patients in both test and/or control groups will take SOC as advised per individual treatment plan and will be asked to monitor signs & symptoms of disease, status of clinical recovery and adverse events, if any. |