| CTRI Number |
CTRI/2020/05/025022 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Hydroxychloroquine in patients with mild COVID-19 illness with risk factors for severe disease |
|
Scientific Title of Study
|
An open label randomised controlled trial to assess the efficacy of Hydroxychloroquine in patients with mild COVID -19 illness with risk factors for severe disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Soneja |
| Designation |
additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND
New Delhi
DELHI
110032
India |
| Phone |
9013074717 |
| Fax |
|
| Email |
manishsoneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Soneja |
| Designation |
additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND
New Delhi
DELHI
110032
India |
| Phone |
9013074717 |
| Fax |
|
| Email |
manishsoneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Soneja |
| Designation |
additional Professor |
| Affiliation |
AIIMS |
| Address |
Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND
New Delhi
DELHI
110032
India |
| Phone |
9013074717 |
| Fax |
|
| Email |
manishsoneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS-Department of Medicine |
|
|
Primary Sponsor
|
| Name |
AIIMS Department of Medicine |
| Address |
Department of Medicine
3rd Floor
Teaching Block
AIIMS -Ansari Nagar |
| 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 |
| DR MANISH SONEJA |
AIIMS |
AIIMS , DEPARTMENT OF MEDICINE
New Delhi
DELHI |
9013074717
MANISHSONEJA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
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 |
HYDROOXYCHLOROQUINE |
HCQ 400 MG BD ON DAY 1 FOLLOWED BY 400 MG OD FOR TOTAL 5 DAYS |
| Comparator Agent |
SYMPTOMATIC TREATMENT |
CONTROL GROUP WILL RECEIVE SYMPTOMATIC TREATMENT which includes paracetamol and other drugs according to symptoms. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with RT-PCR confirmed mild COVID-19 illness with high risk factors
2. Age > 18 years
3. Written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients without any of the high risk factors for severe illness
2. Pregnant women
3. Known hypersensitivity to HCQ
4. Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression to moderate- severe disease |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to clinical resolution of symptoms
2.Incidence of adverse events
|
6 months-Analysis and final report of results |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
06/05/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
there are no proven specific antiviral medications available for treatment of COVID-19 . many antivirals are currently undergoing clinical trials.there is extensive experience with HCQ in management of connective tissue disorder. patient with mild illness with risk factors for severe disease who present within 72 hours of illness will be treated with HCQ for 5 days and evaluated for clinical cure on day 7 after symptom onset. |