| 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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Rathi |
| Designation |
Professor |
| Affiliation |
R D Gardi Medical College |
| Address |
3rd Floor, Department of Pediatrics
R D Gardi Medical College Agar Road, Surasa
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9425093116 |
| Fax |
|
| Email |
sunil.k.rathi.59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Pathak |
| Designation |
Professor |
| Affiliation |
R D Gardi Medical College |
| 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 of Contact Person
Public Query
|
| Name |
Dr Ashish Pathak |
| Designation |
Professor |
| Affiliation |
R D Gardi Medical College |
| 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 |
|
|
Source of Monetary or Material Support
|
| R D Gardi Medical College Agar Road, Surasa, Ujjain
Madhya Pradesh
456006
India |
|
|
Primary Sponsor
|
| Name |
R D Gardi Medical College |
| Address |
Agar Road, Surasa, Ujjain
Madhya Pradesh
456006
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Ashish Pathak |
R D Gardi Medical College, Ujjain |
3rd Floor, Department of Pediatrics
C R Gardi Hospital
R D Gardi medical College
Ujjain
MADHYA PRADESH |
9302239899
drashish.jpathak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R D Gardi Medical College, Ujjain |
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 |
Ivermectin 12mg OD at night
Route of administration- Oral
Duration of therapy - 2 days with standard of care as per hospital guidelines
|
| Comparator Agent |
Standard of care |
Standard of care as per hospital guidelines. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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"
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)
|
24/05/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will be published in relevant open access peer-reviewed scientific journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |