None listed
Conditions
Interventions
Intervention1: Neem capsule 50 mg: Neem capsule 50 mg twice a day for 28 days.
Control Intervention1: Neem capsule 50 mg BID: Neem capsules 50 mg will be self-administered twice daily with water.
Cont
Sponsors
Nisarga Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects will be healthcare personnel (physicians, nurses, chemists, pharmacists, stretcher-bearer, administrative and respiratory therapists) who works in healthcare facility or other well characterized high-risk environment. OR Relative of a patient with COVID-19 infection in a participating hospital 2. Males and females of 18-60 years of age. 3. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals. 4. Not previously diagnosed with COVID-19. 5. Not currently symptomatic with an Acute Respiratory Infection. 6. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods. 7. Ability to swallow and retain oral medication. 8. Willingness and ability to comply with trial and follow-up procedures. 9. Ability to understand the nature of the trial and give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to neem products. 2. Subjects on other prophylactic medications. 3. Age 4. Suspected or confirmed current COVID-19, defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19. 5. Suspected or confirmed convalescent COVID-19, defined as any of the above symptoms within the prior 4 weeks. 6. Subjects who is on angiotensin-converting enzyme (ACE) inhibitor. 7. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. 8. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of symptomatic cases of COVID-19 infectionTimepoint: Within 56 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events of Neem capsuleTimepoint: Within 56 days;Number of asymptomatic cases of COVID-19 infection.Timepoint: Baseline, Day 28 and Day 56;Number of subjects reporting negative COVID-19 test (2019-nCoV RT-PCR).Timepoint: Baseline, Day 28 and Day 56;Rate of severe respiratory COVID-19 infection in symptomatic subjects. Timepoint: Within 56 days | — |
Countries
India
Contacts
Public ContactDr Mohini Barde
Med Indite Communications Pvt Ltd
Outcome results
None listed