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
|
|
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
|
|
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. |