COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51687

Dr Vivekanand Jha

vjha@georgeinstitute.org.in

2022-03-04

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

All adults

1) Inability to provide informed consent or to comply with trial procedures <br/ >2) COVID-19 at time of enrolment â?? either positive SARS CoV-2 swab (PCR) or symptoms highly suggestive of COVID-19 infection <br/ >3) Known chronic liver disease or hepatic dysfunction as evidenced by ALT or AST > 3x upper limit of the normal range <br/ >4) Allergy to niclosamide or history of significant adverse reaction to niclosamide or related compounds, or to any of the excipients used <br/ >5) Significant structural nasal disease in the opinion of the investigator <br/ >6) Pregnant, trying to conceive, unwilling to use contraception or breastfeeding <br/ >7) Participation in another interventional prophylactic or vaccine trial against COVID-19

2

The George Institute New Delhi

18

100

India;United Kingdom

Healthy volunteers

N/A

1500

Time to confirmed symptomatic COVID-19 infectionTimepoint: <br/ > <br/ >Timepoint: 6 months and 9 months <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/ >

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

Phase 2/Phase 3

[{"arm_notes": "Nasal Spray 1% ", "treatment_id": 883, "treatment_name": "Niclosamide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]