eem Prophylaxis for Subjects Coming in Contact with COVID-19 Patients
- Registration Number
- CTRI/2020/07/026560
- Lead Sponsor
- isarga Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 190
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.
1.Known hypersensitivity to neem products.
2.Subjects on other prophylactic medications.
3.Age <18 years old.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of symptomatic cases of COVID-19 infectionTimepoint: Within 56 days
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>Timepoint: Within 56 days