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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
456
Subjects will receive nitazoxanide 500 mg TID for 7 days
Subjects will receive placebo TID for 7 days
Fundación Huésped.
Buenos Aires, Buenos Aires F.D., Argentina
RECRUITINGThe proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Proportion of participants with negative baseline PCR for SARS-CoV-2 who test positive for PCR on day 14 and / or seroconversion on day 28 after initiation of study medication.
Time frame: 28 days
Proportion of adverse events (AE) and serious AE (SAE) related to research product.
Safety and adverse events (AEs).
Time frame: 28 days
Incidence of all causes of study drug withdrawal or discontinuation.
Treatment adherence.
Time frame: 7 days
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