| CTRI Number |
CTRI/2020/06/026232 [Registered on: 29/06/2020] Trial Registered Prospectively |
| Last Modified On: |
29/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Trial |
|
Public Title of Study
|
Ivermectin in the prevention of covid-19 |
|
Scientific Title of Study
|
A Clinical Trial to Study the Efficacy of “Ivermectin” in the prevention of Covid-19. .A Single Arm Study. “ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BKumar |
| Designation |
M.D,,DVFM |
| Affiliation |
DVFM |
| Address |
Department of Medicine, Sivajipalem Main road,
Visakhapatnam
ANDHRA PRADESH
530017
India |
| Phone |
9505637454 |
| Fax |
|
| Email |
bkumar09460946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BKumar |
| Designation |
M.D,,DVFM |
| Affiliation |
DVFM |
| Address |
Department of Medicine, Sivajipalem Main road,
Visakhapatnam
ANDHRA PRADESH
530017
India |
| Phone |
9505637454 |
| Fax |
|
| Email |
bkumar09460946@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BKumar |
| Designation |
M.D,,DVFM |
| Affiliation |
DVFM |
| Address |
Department of Medicine, Sivajipalem Main road,
Visakhapatnam
ANDHRA PRADESH
530017
India |
| Phone |
9505637454 |
| Fax |
|
| Email |
bkumar09460946@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVFM,
Department Of Medicine,
Block A ,
Sivajipalem main raoad,
Sivajipalem
Visakhapatnam-530017
Andhra pradesh |
|
|
Primary Sponsor
|
| Name |
DVFM |
| Address |
Department of Medicine, Sivajipalem Main road ,Visakhpatnam-17 ANDHRA PRADESH 530017 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| BKumar |
DVPM |
Department of Medicine, Sivajipalem Main road ,
Visakhapatnam
ANDHRA PRADESH |
9505637454
bkumar09460946@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMA INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers who have high chances of exposure to COVID 19 patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ivermectin |
Single oral dose of 200 mcg of ivermectin per kg of body weight. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are not suffering from active illness due to infection at the time of inclusion . |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Subjects suffering from active illness due to infection at the time of inclusion.
3.Subjects suffering from uncontrolled DM, HTN etc
4.Subjects who are known cases of immune-compromised or autoimmune condition such as HIV. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19 patients. |
From Baseline till the end of 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirement of treatment for symptoms developed, if any, during study period.
Incidence of COVID 19 infection in study population.
Analysis of adverse events, if any |
From Baseline till the end of 15 days.
From Baseline till the end of 15 days.
From Baseline till the end of 15 days.
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/07/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COVID-19 ,a viral disease with common symptoms dry cough, fever, breath problems , fatigue , loss of smell and others.
Prevent is better option than treatment .
There are many possible methods to prevent Covid-19 , Mask usage , Maintain social distance , frequent hand wash and others . But in world wide the positive of COVID-19 increasing very fast.
IVERMECTIN is approved by DCGI ,Government of India for anti-parasitic but this medicine have anti viral properties.
This IVERMECITIN may prevent Covid-19 Infection .At starting point of viral infection the Viral load is very much less . So this medicine may prevent Covid-19 infection .It is very safe drug . |