IND02 for prevention against SARS-CoV-2 Infection: A Randomized controlled study in moderate to high risk populatio

Phase 2

Completed

• Registration Number: CTRI/2020/10/028547
• Lead Sponsor: Indus Biotech Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 258

Inclusion Criteria

1. Subjects population will be healthcare personnel (physicians, nurses, laboratory staff, pharmacists, technicians, stretcher-bearer, ambulance driver, respiratory therapists, administrative staff) who work in healthcare facility or any other moderate to high-risk environment (public servants like policemen, municipal corporation workers) OR relative of a patient inclusive of those with direct/primary contact with positive COVID-19 infection

2. Age 18-60 years

3. Subject has not taken any prophylaxis medication for COVID-19 in last 30 days

4.Subject agrees not to self-medicate with chloroquine, hydroxychloroquine, other potential antivirals or any other alternative medicines /supplements as a part of prevention of SARS-CoV-2 infection.

5. Willing and able to provide written informed consent prior to performing study procedures

6.Healthy at the time of enrolment without any symptoms suggestive of any viral infection

7.Negative test for COVID-19 infection by RT-PCR using ICMR/WHO protocol

8. Not previously diagnosed with COVID-19

9. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use adequate contraceptive methods.

Exclusion Criteria

1. Subjects with a history of allergy or intolerance to Cinnamon

2. Participation in any other clinical study for COVID-19

3. Laboratory confirmed COVID-19 with or without symptoms

4. Pregnancy and Lactation mothers, and those who are planning for pregnancy

5. Patients with serious, critical illness, or severe mental illness

6. Any other condition, which the Principal Investigator thinks, may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of COVID-19 infection free subjects on study completion in both the groupsTimepoint: Proportion of COVID-19 infection free subjects on study completion in both the groups