Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
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|ClinicalTrials.gov Identifier: NCT04435314|
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|covid19||Drug: Nitazoxanide Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Subjects will receive nitazonanide 600 mg TID.
Subjects will receive nitazonanide 600 mg TID for 7 days
Other Name: Viranitta
Placebo Comparator: Placebo
Subjects will receive placebo TID.
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 [ Time Frame: 28 days ]PCR will be done to evaluate infection
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 28 days ]Number of participants with treatment-related adverse events
- The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study [ Time Frame: 28 days ]Symptomatic PCR positive subjects
- The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study [ Time Frame: 28 days ]Asymptomatic PCR will be done to evaluate infection
- Treatment adherence [ Time Frame: 7 days ]Subject adherence to treatment will be assessed through study diary record
- Disease complication [ Time Frame: 28 days ]Proportion of patients with severe condition
- Incidence of subjects that underwent unscheduled visit [ Time Frame: 28 days ]Proportion of patient that needed undergo an unscheduled visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435314
|Contact: Marcelo Fonseca, MD||+55 11 email@example.com|
|Contact: Luciana Ferrara||+55 19 firstname.lastname@example.org|
|Principal Investigator:||Reginaldo Raimundo Fujita||Federal University of São Paulo|