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CTRI Number  CTRI/2020/06/026191 [Registered on: 27/06/2020] Trial Registered Prospectively
Last Modified On: 27/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the safety and efficacy of Vitamin D3, Vitamin K2-7 & magnesium , in prevention of COVID 19 infection in health care professional (HCP) 
Scientific Title of Study   Randomized, Double Blind, Comparative, Parallel group study of Vitamin D3 ( Cholecalciferol ) Vitamin K2-7 & magnesium in prophylaxis of COVID-19 infection in health care professionals  
Trial Acronym  Covid19 
Secondary IDs if Any  
Secondary ID  Identifier 
MUR/01/2020  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AVN Sridhar 
Designation  Associate Vice President 
Affiliation  suraksha pharma 
Address  Suraksha Towers, Ameerpet

Hyderabad
TELANGANA
500073
India 
Phone    
Fax    
Email  svp@surakshapharma.com  
 
Details of Contact Person
Scientific Query  
Name  AVN Sridhar 
Designation  Associate Vice President 
Affiliation  suraksha pharma private limited 
Address  Suraksha Towers, Ameerpet

Hyderabad
TELANGANA
500073
India 
Phone    
Fax    
Email  svp@surakshapharma.com  
 
Details of Contact Person
Public Query  
Name  AVN Sridhar 
Designation  Associate Vice President 
Affiliation  suraksha pharma private limited 
Address  Suraksha Towers, Ameerpet

Hyderabad
TELANGANA
500073
India 
Phone    
Fax    
Email  svp@surakshapharma.com  
 
Source of Monetary or Material Support  
Suraksha Pharma Private Limited, 8-3-895/8, Suraksha Towers, Ameerpet, Hyderabad - 500073 
 
Primary Sponsor  
Name  Suraksha Pharma Private Limited 
Address  8-3-895, Suraksha Towers, Ameerpet, Hyderabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sudarsi B  A C Subba Reddy Medical Hospital  Department of General Medicine, 3rd Room from Left, 1st Floor, IP Block
Nellore
ANDHRA PRADESH 		 9550845095

dr_sudarsi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AC Subba Reddy Medical Hospital & College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Vitamin D3 ( Cholecalciferol VITAMIN D3) 60,000 I U/ weekly for 5 Weeks 2 Vitamin K2-7 100 mcg / day for 5 weeks 3 Magnesium Glycinate 250 mg/day for 5 weeks   1 Vitamin D(Cholecalciferol Vitamin D3 )60,000 I U. , weekly with milk for 5 weeks 2 Vitamin K2-7 100 mcg / day for 5 weeks 3 Magnesium glycinate 250 mg / day for 5 weeks  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants of either sex, 20 to 60 years of age who are at high risk. High-risk individuals are defined as all health care professionals in hospitals, clinics, and emergency rooms, and medical facilities involved in management of COVID -19 patients.
(Doctors, nursing staff, paramedical staff, ambulance staff, other hospital staff, ward attendees coming in contact with COVID -19 patients).
2. Participants who are negative for RT-PCR test for COVID-19 infection
3. Participants who are willing to provide inform consent and willing to come for schedule follow up visit.
4. Participant not having contra indication to take Vitamin D,
5. Participants having no COVID- 19 infection clinically.
6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study.
 
 
ExclusionCriteria 
Details  1 Participants with known allergy or contraindication to Vitamin D ,Vitamin K2-7 & Magnesium .
2 History of having received any investigational drug in the preceding one month.
3 History of taking any kind of formulation or any other form of therapy for COVID- 19 prophylaxis.
4 Unwilling to come for regular follow-up for the entire duration of the study.
5 Any condition that, in the opinion of the investigator, does not justify the subject‘s inclusion in the study.
6 Participants participating in other clinical study.
7 Participant receiving other immune enhancers.
8 Refusal to sign informed consent form
9 Any previous positive test for COVID-19 by RT- PCR
10 Symptomatic for COVID-19
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the safety and efficacy of Vitamin D3, Vitamin K2-7 & magnesium , in prevention of COVID 19 infection in health care professional (HCP)  Development of COVID- 19 infection in 5 weeks study period . 
 
Secondary Outcome  
Outcome  TimePoints 
1. Prevention of COVID-19 measured by negative testing with RT-PCR( In symptomatic participants ) [Time Frame 5 weeks]
2. To determine if treatment with Vitamin D can prevent COVID-19 infection [ Time Frame 5 week]
 		 5 Weeks 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/08/2020 
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)   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  

This open label study will be conducted    in  all   health care professionals ,  who are in  high risk of getting COVID- 19 , due to very close contact  during the management of  COVID- 19 positive  patients.

      Study protocol and other study related documents will receive written approval from the ethic committee before initiation of any study related activity.

          Every participant will be explained about the study  in detail, and allowed to ask any question about study related activity  Participant who are willing to participate  in this present study will provide  written consent. Participation is voluntary and one can withdraw from the study any time.

 
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