NCT04788407

Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts

Pilot Study of Safety and Efficacy of Nitazoxanide in Post-exposure Prophylaxis in Household Contacts of Patients With Confirmed SARS-CoV-2 Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Fundación Huésped · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease.

Detailed description

Eligible participants (cohabitants of a recently confirmed COVID19 case) residing in Buenos Aires City will be identified by the Ministry of Health and contacted with the investigators, who will visit them at home and offer to participate. For consenting individuals, a rapid serological test and a nasopharyngeal PCR sample for SARS-CoV-2 will be performed and participants will be then randomized to NTZ or placebo to be taken during 7 days. SARS-CoV-2 PCR will be repeated on day 14th and the serologic rapid test repeated on day 28th. Clinical status of participants will be assessed daily by phone. Individuals meeting case definition will be evaluated at home and a PCR will be performed. Those with confirmed COVID19 case will discontinue study medication and followed until symptoms resolution.

Conditions

• Covid19
• SARS-CoV-2 Infection
• Households Contacts

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Subjects will receive nitazoxanide 500 mg TID for 7 days
DRUG	Placebo	Subjects will receive placebo TID for 7 days

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2021-03-09
• Last updated: 2021-07-02

Locations

1 site across 1 country: Argentina