| CTRI Number |
CTRI/2020/08/027225 [Registered on: 18/08/2020] Trial Registered Prospectively |
| Last Modified On: |
05/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ivermectin as a possible treatment for COVID-19 |
|
Scientific Title of Study
|
Ivermectin as a potential treatment for COVID 19: A double blind randomized placebo-controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Kirti |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of General Medicine,
1st Floor, OPD Building,
AIIMS, Phulwari Sharif, Patna
Patna
BIHAR
801507
India |
| Phone |
9572424447 |
| Fax |
|
| Email |
drravikirti@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Kirti |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of General Medicine, 1st Floor,OPD Building
AIIMS, Phulwari Sharif
Patna
Patna
BIHAR
801507
India |
| Phone |
9572424447 |
| Fax |
|
| Email |
drravikirti@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Kirti |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of General Medicine
1st Floor, OPD Building
AIIMS, Phulwari Sharif
Patna
Patna
BIHAR
801507
India |
| Phone |
9572424447 |
| Fax |
|
| Email |
drravikirti@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Phulwari Sharif, Patna 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Phulwari Sharif
Patna 801503 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravikirti |
AII India Institute of Medical Sciences, Patna |
COVID Wards, IPD Building, AIIMS
Phulwari Sharif
Patna 801507
Patna
BIHAR |
9572424447
drravikirti@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ivermectin |
12 mg orally to be administered once daily on days 1 and 2 |
| Comparator Agent |
Placebo tablets |
A placebo tablet similar to Ivermectin 12 mg (provided by the manufacturer) to be given once daily on days 1 and 2. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with COVID-19 with mild to moderate severity |
|
| ExclusionCriteria |
| Details |
History of allergy to Ivermectin
Unwillingness to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Negative RT-PCR |
Day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In-hospital mortality |
NA |
| ICU Admission |
NA |
| Mechanical Ventilation |
NA |
| Discharge by day 10 |
Day 10 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "115"
Final Enrollment numbers achieved (India)="115" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2020 |
| Date of Study Completion (India) |
31/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Ivermectin is a widely used and safe anti-parasitic drug. It has been reported to have an in-vitro activity against SARS-CoV-2. However, no randomized controlled trial has been done yet to study the efficacy of this drug in COVID-19.
The proposed study is a single center study to assess the efficacy of the drug in COVID-19 cases with mild to moderate severity as defined by the Ministry of Health and Family Welfare, Government of India.
|