COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45075

AVN Sridhar

svp@surakshapharma.com

2020-06-27

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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. <br/ >(Doctors, nursing staff, paramedical staff, ambulance staff, other hospital staff, ward attendees coming in contact with COVID -19 patients). <br/ >2. Participants who are negative for RT-PCR test for COVID-19 infection <br/ >3. Participants who are willing to provide inform consent and willing to come for schedule follow up visit. <br/ >4. Participant not having contra indication to take Vitamin D, <br/ >5. Participants having no COVID- 19 infection clinically. <br/ >6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study. <br/ >

1 Participants with known allergy or contraindication to Vitamin D ,Vitamin K2-7 & Magnesium . <br/ >2 History of having received any investigational drug in the preceding one month. <br/ >3 History of taking any kind of formulation or any other form of therapy for COVID- 19 prophylaxis. <br/ >4 Unwilling to come for regular follow-up for the entire duration of the study. <br/ >5 Any condition that, in the opinion of the investigator, does not justify the subjectâ??s inclusion in the study. <br/ >6 Participants participating in other clinical study. <br/ >7 Participant receiving other immune enhancers. <br/ >8 Refusal to sign informed consent form <br/ >9 Any previous positive test for COVID-19 by RT- PCR <br/ >10 Symptomatic for COVID-19 <br/ >

2

Suraksha Pharma Private Limited

20

60

India

Health workers

N/A

500

To study the safety and efficacy of Vitamin D3; Vitamin K2-7 & magnesium ; in prevention of COVID 19 infection in health care professional (HCP)Timepoint: Development of COVID- 19 infection in 5 weeks study period .

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 2222, "treatment_name": "Magnesium sulfate+vitamin d3+vitamin k2", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]