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CTRI Number  CTRI/2020/06/026189 [Registered on: 26/06/2020] Trial Registered Prospectively
Last Modified On: 26/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare the safety and efficacy of Vitamin D, with Magnesium in mild to moderate Covid 19 patients 
Scientific Title of Study   Randomized, Double Blind, Parallel Group Study of Vitamin D3 & Magnesium in Covid 19 Infection 
Trial Acronym  Covid 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AVN Sridhar 
Designation  Associate Vice President 
Affiliation  suraksha pharma 
Address  8-3-898/5, 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 
Address  8-3-898/5, 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 
Address  8-3-898/5, 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  8-3-898/5, 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 Neethi Chandra  A C Subba Reddy Medical Hospital  Department of Pulmonary Medicine, 1st Floor, IP Block
Nellore
ANDHRA PRADESH 
9573972415

neethi772@gmail.com 
 
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  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cholecalciferol vitamin D 3 Magnesium Glycinate   Vitamin D 60000 IU Single Dose + Magnesium Glycinate 250mg BD for 14 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex, 20 to 60 years of age with mild – moderate COVID -19 infection , found positive for COVID -19 test by RT_PCR are requiring Clinical management
( symptomatic patients who present with cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, insomnia, ageusia or alternative signs of respiratory infections.)
2. Participants who are willing to provide inform consent and willing to come for schedule follow up visit.
3. Participants who are having normal hematological renal hepatic Parameters
4. Participant not having contra indication to take standard treatment Vitamin D, magnesium
5. Participants tested positive for COVID 19 by nose throat swab using PCR technique
6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study.
 
 
ExclusionCriteria 
Details  1. Patient having severe COVID -19 infection
2. Patients presenting severe respiratory and/or multi systemic symptoms compatible with advanced COVID-19 and inter current acute or severe chronic diseases (i.e. active cancer).
3. Participants with hypersensitivity or intolerance or contraindication to the use of standard treatment
4. Participants with known allergy or contraindication to Vitamin D, Magnesium
5. History of having received any investigational drug in the preceding one month.
6. History of taking any kind of formulation or any other form of therapy for COVID 19 prophylaxis .
7. Unwilling to come for regular follow-up for the entire duration of the study.
8. COVID -19 RT-PCR Negative
9. Any condition that, in the opinion of the investigator, does not justify the subject‘s inclusion in the study.
10. Participants participating in other clinical study.
11. Participant receiving other immune enhancers.
12. Refusal to sign informed consent form
13. Symptomatic for sever COVID-19 infection needing ICU
14. Atherosclerotic Coronary Artery Disease
 
 
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 
Negative RT- PCR test for COVID 19 infection
2 Improvement in Signs and symptoms of COVID 19 infection, use of ventilator, length of stay in ICU
3 Reduction in CRP levels
4 Reduction in rate of COVID -19 complication .
5 Speed of recovery and duration to becoming asymptomatic
6 Length of hospital stay
 
COVID 19 RT-PCR Test in 2 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the safety and efficacy of Vitamin D
( Cholecalciferol ) , with Magnesium in mild to moderate COVID- 19 patients
 
3 weeks 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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 
Brief Summary  

This randomized ,  double blind parallel group   study will be conducted   in   mild to moderate COVID- 19 patients who are admitted in the COVID care facility for management and are found positive for COVID -19 RT-PCR test. All patients will receive the standard treatment   For  COVID -19 infection as per the recommendation   of  national   guidelines  .

  Participants will be divided in to 2 arms for the study.

  Arm I  participants   in a “Standard  dose  group”  will receive  standard COVID-19  treatment, and  Vitamin D 60,000 IU single dose plus  Magnesium Glycinate 250mg BD for 14 days.

 Participants    in arm  II  an  “High dose  group”   will  receive standard COVID-19  treatment , and Vitamin D 4,00,000 I U single dose plus   Magnesium Glycinate 250 mg BD for 14 days .

    All the participants will be explained in detail about the study, and other details as per participant information sheet . Each Participant will provide a written inform consent before any study related activity.

      Participant will be   informed that her or his participation is voluntary and he or she can withdraw any time from the study. Once the study participant full fill inclusion and exclusion criteria he or she will be randomized in to one of the study arm of COVID-19 study.    This randomized ,  double blind parallel group   study will be conducted   in   mild to moderate COVID- 19 patients who are admitted in the COVID care facility for management and are found positive for COVID -19 RT-PCR test. All patients will receive the standard treatment   For  COVID -19 infection as per the recommendation   of  national   guidelines  .

  Participants will be divided in to 2 arms for the study.

  Arm I  participants   in a “Standard  dose  group”  will receive  standard COVID-19  treatment, and  Vitamin D 60,000 IU single dose plus  Magnesium Glycinate 250mg BD for 14 days.

 Participants    in arm  II  an  “High dose  group”   will  receive standard COVID-19  treatment , and Vitamin D 4,00,000 I U single dose plus   Magnesium Glycinate 250 mg BD for 14 days .

    All the participants will be explained in detail about the study, and other details as per participant information sheet . Each Participant will provide a written inform consent before any study related activity.

      Participant will be   informed that her or his participation is voluntary and he or she can withdraw any time from the study. Once the study participant full fill inclusion and exclusion criteria he or she will be randomized in to one of the study arm of COVID-19 study.    

 
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