| CTRI Number |
CTRI/2020/04/024858 [Registered on: 25/04/2020] Trial Registered Prospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
“To study the effectiveness of Ivermectin with standard of care treatment
versus standard of care treatment for COVID 19 cases. A Pilot Study |
|
Scientific Title of Study
|
“To study the effectiveness of Ivermectin with standard of care treatment
versus standard of care treatment for COVID 19 cases. A Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Budhiraja |
| Designation |
Group Medical Director Director |
| Affiliation |
Internal Medicine, Max Super Speciality Hospital (DDF), Saket |
| Address |
Max Super Speciality Hospital (DDF), East Block, Internal Medicine department, 2- Press Enclave Road, New Delhi
New Delhi
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
sbudhiraja@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Shankar Mishra |
| Designation |
Director- Internal Medicine |
| Affiliation |
Internal Medicine, Max Super Speciality Hospital (DDF), Saket |
| Address |
Max Super Speciality Hospital (DDF), East Block, Internal Medicine Department, 2- Press Enclave Road, New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9810193145 |
| Fax |
|
| Email |
docmishra@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Saxena |
| Designation |
General Manager |
| Affiliation |
Office of research, Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) |
| Address |
Max Super Speciality Hospital (DDF), East Block, Service Floor, 2- Press Enclave Road, New Delhi
New Delhi
DELHI
110017
India |
| Phone |
9818474003 |
| Fax |
|
| Email |
rajesh.saxena@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital (DDF) Saket |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital A Unit of Devki Devi Foundation |
| Address |
2, Press
Enclave Road, Saket, New Delhi-17 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sandeep Budhiraja |
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) |
Department of Internal Medicine, 2, Press
Enclave Road, Saket, New Delhi-17
New Delhi
DELHI |
9810262954
sbudhiraja@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ivermectin |
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. |
|
| ExclusionCriteria |
| Details |
Patients who are critically sick |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the drug vs standard care of treatment will be checked |
Treatment will be provided until the eradication of virus or completion of
the trial. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2020 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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.
ï‚· Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the
hospital ï‚· Clinical profile of the patient every day of hospitalization ï‚· Investigation of pulmonary function and O2 saturation every day of hospitalization ï‚· The day a patient is put on ventilator and the day when removed ï‚· 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. |