The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease. Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Subjects will receive nitazonanide 600 mg TID for 7 days
Subjects will receive placebo TID for 7 days.
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
PCR will be done to evaluate infection
Time frame: 28 days
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events
Time frame: 28 days
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Symptomatic PCR positive subjects
Time frame: 28 days
The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
Asymptomatic PCR will be done to evaluate infection
Time frame: 28 days
Treatment adherence
Subject adherence to treatment will be assessed through study diary record
Time frame: 7 days
Disease complication
Proportion of patients with severe condition
Time frame: 28 days
Incidence of subjects that underwent unscheduled visit
Proportion of patient that needed undergo an unscheduled visit
Time frame: 28 days
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