COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45029

AVN Sridhar

svp@surakshapharma.com

2020-06-26

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Patients of either sex, 20 to 60 years of age with mild â?? moderate COVID -19 infection , found positive for COVID -19 test by RT_PCR are requiring Clinical management <br/ > ( symptomatic patients who present with cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, insomnia, ageusia or alternative signs of respiratory infections.) <br/ >2. Participants who are willing to provide inform consent and willing to come for schedule follow up visit. <br/ >3. Participants who are having normal hematological renal hepatic Parameters <br/ >4. Participant not having contra indication to take standard treatment Vitamin D, magnesium <br/ >5. Participants tested positive for COVID 19 by nose throat swab using PCR technique <br/ >6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study. <br/ >

1. Patient having severe COVID -19 infection <br/ >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). <br/ >3. Participants with hypersensitivity or intolerance or contraindication to the use of standard treatment <br/ >4. Participants with known allergy or contraindication to Vitamin D, Magnesium <br/ >5. History of having received any investigational drug in the preceding one month. <br/ >6. History of taking any kind of formulation or any other form of therapy for COVID 19 prophylaxis . <br/ >7. Unwilling to come for regular follow-up for the entire duration of the study. <br/ >8. COVID -19 RT-PCR Negative <br/ >9. Any condition that, in the opinion of the investigator, does not justify the subjectâ??s inclusion in the study. <br/ >10. Participants participating in other clinical study. <br/ >11. Participant receiving other immune enhancers. <br/ >12. Refusal to sign informed consent form <br/ >13. Symptomatic for sever COVID-19 infection needing ICU <br/ >14. Atherosclerotic Coronary Artery Disease <br/ >

2

Suraksha Pharma Private Limited

20

60

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

210

Negative RT- PCR test for COVID 19 infection <br/ >2 Improvement in Signs and symptoms of COVID 19 infection; use of ventilator; length of stay in ICU <br/ >3 Reduction in CRP levels <br/ >4 Reduction in rate of COVID -19 complication . <br/ >5 Speed of recovery and duration to becoming asymptomatic <br/ > 6 Length of hospital stay <br/ >Timepoint: COVID 19 RT-PCR Test in 2 weeks <br/ >

Phase 2

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