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CTRI Number  CTRI/2020/06/025613 [Registered on: 04/06/2020] Trial Registered Prospectively
Last Modified On: 18/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Melatonin Immune Boost COVID 19 Study 
Scientific Title of Study   Melatonin For COVID 19 pre exposure prophylaxis in High Risk population . (MELATONIN IMMUNE BOOST COVID 19 STUDY )  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103 , Department of Cardiology , All India Institute of medical Science ,Rishikesh , Uttrakhand , India

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103 , Department of Cardiology , All India Institute of medical Science ,Rishikesh , Uttrakhand , India

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103 , Department of Cardiology , All India Institute of medical Science ,Rishikesh , Uttrakhand , India

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Rishikesh , Virbhadra Road , Pashulok , Rishikesh , Uttarakhand  
 
Primary Sponsor  
Name  Rohit Walia  
Address  Room number 25103 , Department of Cardiology , All India Institute of Medical Science Rishikesh ,Uttarakhand , India  
Type of Sponsor  Other [self] 
 
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 
Rohit Walia   All India Institute of Medical Science Rishikesh   Room number 25103, Department of Cardiology ,All India Institute of Medical Science Virbhadra Road , Pashulok , Rishikesh
Dehradun
UTTARANCHAL 		 8800492549

rwalia7731@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Science Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  High risk for Covid 19  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Melatonin   Oral melatonin 3 mg at 6 pm daily once x 8 weeks  
Comparator Agent  Placebo   Placebo for 8 weeks  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  High groups for COVID 19 related disease
Elderly : age > 60 years
Diabetes
Obesity
Heart Failure
Immuno supressed patients
 
 
ExclusionCriteria 
Details  Chronic Renal Failure
Chronic Hepatic Failure
Any hospitalisation for past 3 months
Any recent vaccination
Nutrition supplements
Any addiction
Chronic infections live Human immunodeficiency disorder , Hepatitis B,C., etc
Any autoimmune disease
Irregular sleep pattern
Primary immunodeficiency states
Vitamin deficiency states 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
SARS-CoV 2 infection rate : Number of confirmed (positive CRP) symptomatic infections in each treatment group
 		 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 

Frequency of respiratory tract infections during course of study using the 
Wisconsin Upper Respiratory Symptom Survey
 		 8 weeks  
Change from baseline immune cells and markers after 8 weeks of medications
 		 8 weeks  
Number of participants with treatment-related adverse events  8 weeks  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 4 
Date of First Enrollment (India)   15/06/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Elderly , cardiovascular , obesity are high risk for COVID related severe disease and high mortality and needs to be protected. With advance age immune system go immune senescence and innate immunity is weakened.Decrease in  Melatonin has been linked to immunosenesence. Melatonin is safe, inexpensive , proven effect as adjuvant treatment for bacterial and viral infections , anti oxidative and anti inflammatory effect . Melatonin enhances the production of progenitor cells of granulocyte , macrophage and natural killer cells , increases production of IL2,IL6,IL12 and increases helper T cells. It can reverse immunosenescence of old age and immunocompromised states and prevent them from COVID related disease. We study Melatonin oral 3 mg vs placebo in high risk groups for prevention of COVID 19 disease. We study Covid infection rate and other infections and immune response at baseline and 8 weeks in both groups.  
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