Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: nitazoxanide Subjects will receive nitazonanide 600 mg TID. |
Drug: Nitazoxanide
Subjects will receive nitazonanide 600 mg TID for 7 days
Other Names:
|
| Placebo Comparator: Placebo Subjects will receive placebo TID. |
Drug: Placebo
Subjects will receive placebo TID for 7 days.
|
Outcome Measures
Primary Outcome Measures
- The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study [28 days]
PCR will be done to evaluate infection
Secondary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [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 [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 [28 days]
Asymptomatic PCR will be done to evaluate infection
- Treatment adherence [7 days]
Subject adherence to treatment will be assessed through study diary record
- Disease complication [28 days]
Proportion of patients with severe condition
- Incidence of subjects that underwent unscheduled visit [28 days]
Proportion of patient that needed undergo an unscheduled visit
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed consent from patient or legal representative.
-
Subject of both genders (male and female not pregnant and not breastfeeding) aged 18 years or over;
-
Subject that lives in a vulnerable community;
-
Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
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Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
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Participant capable of understanding and fulfilling all activities planned for the study;
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In use of an acceptable method of contraception throughout the study.
Exclusion Criteria:
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Participating in another RCT in the past 12 months;
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Positive PCR result for COVID-19 during screening;
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History of infection confirmed by SARS-CoV-2;
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Present symptoms suggestive of SARS-CoV-2 infection;
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Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:
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HIV or HTLV virus infection;
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Chronic hepatitis C (HCV) treated with direct antiviral drugs;
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Liver failure;
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Severe renal failure, including dialysis;
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Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
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Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
-
Participants who underwent treatment with antivirals and / or antiparasitic drugs in the last 30 days;
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Subject in antineoplastic treatment with chemotherapy or radiation therapy;
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Subject with severe autoimmune diseases in immunosuppression;
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Transplanted participants;
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Pregnant or lactating women;
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Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Azidus Brasil
- Farmoquimica S.A.
Investigators
- Principal Investigator: Reginaldo Raimundo Fujita, Federal University of São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NITFQM0620OR