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CTRI Number  CTRI/2020/05/025022 [Registered on: 05/05/2020] Trial Registered Prospectively
Last Modified On: 05/05/2020
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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. 
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