CTRI Number |
CTRI/2020/05/025068 [Registered on: 07/05/2020] Trial Registered Prospectively |
Last Modified On: |
07/05/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Can a medicine help in curing viral infection |
Scientific Title of Study
|
A Phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection |
Trial Acronym |
Not applicable |
Secondary IDs if Any
|
Secondary ID |
Identifier |
Not applicable |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Biju George |
Designation |
Professor and Head |
Affiliation |
Christian Medical College Vellore |
Address |
Department of Haematology,
First Floor, Room no-3,
Christian Medical College
Vellore TAMIL NADU 632004 India |
Phone |
04162282352 |
Fax |
04162226449 |
Email |
biju@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Biju George |
Designation |
Professor and Head |
Affiliation |
Christian Medical College Vellore |
Address |
Department of Haematology,
First Floor, Room no-3,
Christian Medical College Department of Haematology,
First Floor, Room no-3,
Christian Medical College
TAMIL NADU 632004 India |
Phone |
04162282352 |
Fax |
04162226449 |
Email |
biju@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Biju George |
Designation |
Professor and Head |
Affiliation |
Christian Medical College Vellore |
Address |
Department of Haematology,
First Floor, Room no-3,
Christian Medical College Department of Haematology,
First Floor, Room no-3,
Christian Medical College
TAMIL NADU 632004 India |
Phone |
04162282352 |
Fax |
04162226449 |
Email |
biju@cmcvellore.ac.in |
|
Source of Monetary or Material Support
|
Christian Medical College Vellore, Ida Scudder Road, Vellore, 632004, Tamil Nadu |
|
Primary Sponsor
|
Name |
Christian Medical College Vellore |
Address |
Christian Medical College,
Vellore, 632004,
Tamil Nadu, India |
Type of Sponsor |
Other [Charitable trust hospital] |
|
Details of Secondary Sponsor
|
Name |
Address |
cience and Engineering Research Board SERB |
5 & 5A, Lower Ground Floor
Vasant Square Mall
Sector-B, Pocket-5
Vasant Kunj
New Delhi – 110 070 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Biju George |
Christian Medical College Vellore |
Department of Haematology,
Christian Medical College,
Vellore, 632004 Vellore TAMIL NADU |
04162282352 04162226449 biju@cmcvellore.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee - Institution Review Board |
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 |
The doses are as follows (based on body weight)
15 - 24 kg: 3 mg PO once
25 - 35 kg: 6 mg PO once
36 - 50 kg: 9 mg PO once
51 - 65 kg: 12 mg PO once
66 - 79 kg: 15 mg PO once
80 kg and 15 kg: 200 ug/kg PO once |
Comparator Agent |
patients will receive the standard protocol for management of COVID 19 infection. |
patients will receive the standard protocol for management of COVID 19 infection. |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Confirmed diagnosis of COVID19 infection based on +ve RTPCR
|
|
ExclusionCriteria |
Details |
Patients with other viral infections |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To study if Ivermectin can reduce the viral load in patients with hematological illnesses who are admitted with COVD19 infection |
Day 7
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the factors that affect viral load reduction
To study if the reduction in viral load correlates with improvement in inflammatory parameters
To study the incidence of serious adverse events and safety of this drug when used in hematological illnesses |
Day 7
Day 20 |
|
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)
|
27/05/2020 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
We will plan to publish the results of this study in reputed National and International Journals. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Corona virus disease 2019, a recently declared pandemic by the World Health Organization, is associated with a mortality ranging from 1-5% in immunocompetent individuals and will probably results in higher mortality in immunosuppressed patients. One of the important factors affecting outcomes including morality and ICU admission has been the viral load at the onset of disease and the rate of viral clearance. There are no standard drugs that are of proven benefit against the COVID 19 virus and majority of the treatment has been supportive. Recent data has suggested that ivermectin, an antiparasitic drug, is able to cause a 5000 fold reduction in viral RNA at 48 hours post exposure in cell lines. Ivermectin is a very safe drug to use in immunosuppressed patients for treatment of parasitic infections and has a good safety and tolerability profile. In this study, we would like to randomize patients into 2 groups – group A will get the standard treatment protocol for COVID 19 infection as per institutional protocols and Group B will receive the standard treatment along with Ivermectin given on day 1 and Day 8. Baseline samples will be collected to look for presence of cytopenia, coagulopathy and also status of the immune system. The PCR samples will be stored for quantification of the viral load at a later point of time. PCR samples will be repeated on alternate days starting on Day 1 followed by 3, 5, 7, 10 and 14 and then at weekly intervals till discharge/death. All patients will be followed till recovery from illness or death. Blood parameters that are abnormal will be repeated twice a week till discharge. We will study whether there is a rapid clearance of the virus with the use of ivermectin and whether that has led to better outcomes.
Results and Conclusion: We will be able to study if ivermectin reduces the viral load and whether this reduction will lead to stabilization of disease and clinical findings including the inflammatory parameters.
|