A study to test a preventive drug for COVID-19 among patients with compromised immunity
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2022/03/040802
- Lead Sponsor
- The George Institute New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All adults
Exclusion Criteria
1) Inability to provide informed consent or to comply with trial procedures
2) COVID-19 at time of enrolment – either positive SARS CoV-2 swab (PCR) or symptoms highly suggestive of COVID-19 infection
3) Known chronic liver disease or hepatic dysfunction as evidenced by ALT or AST > 3x upper limit of the normal range
4) Allergy to niclosamide or history of significant adverse reaction to niclosamide or related compounds, or to any of the excipients used
5) Significant structural nasal disease in the opinion of the investigator
6) Pregnant, trying to conceive, unwilling to use contraception or breastfeeding
7) Participation in another interventional prophylactic or vaccine trial against COVID-19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to confirmed symptomatic COVID-19 infectionTimepoint: <br/ ><br> <br/ ><br>Timepoint: 6 months and 9 months <br/ ><br>The primary endpoint will be censored at the date of last treatment administered for participants who have not experienced the primary outcome event. Asymptomatic positive COVID-19 participants will be followed up for a maximum of 4 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method a.Time to confirmed SARS-Cov-2 infection from the date of randomisation including asymptomatic casesTimepoint: 4 weeks;b.Comparison of proportion of individuals between groups with antibodies to SARS-Cov-2 at the end of the trialTimepoint: End of the trial;Common COVID-19 complications (including ARDS, viral pneumonitis, myocarditis/myocardial injury, AKI)Timepoint: x;Length of inpatient stayTimepoint: x;Occurrence of other influenza infection (swab confirmed) <br/ ><br>Timepoint: x;Safety and All-cause MortalityTimepoint: x;Severity of COVID-19 diseaseTimepoint: 28 days after the COVID positive test