Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID-19
  • Households Contacts
  • SARS CoV-2 Infection
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, Cluster-Randomized, double-blind, placebo-controlled clinical trial.Masking: Double (Participant, Investigator)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 n...

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.

Tracking Information

NCT #
NCT04788407
Collaborators
  • Ministerio de Salud de Ciudad Autónoma de Buenos Aires
  • Laboratorios Roemmers S.A.I.C.F.
Investigators
Study Director: Omar Sued, MD PhMD Fundacion Huesped. Principal Investigator: Herman K Ludvik, MD Fundación Huésped
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