| 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
|
|
|
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
|
|
|
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 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |