Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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covid19

Intervention / Treatment
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* Drug: Nitazoxanide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; 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; Participant capable of understanding and fulfilling all activities planned for the study; In use of an acceptable method of contraception throughout the study. Exclusion Criteria: Participating in another RCT in the past 12 months; Positive PCR result for COVID-19 during screening; History of infection confirmed by SARS-CoV-2; Present symptoms suggestive of SARS-CoV-2 infection; Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to: HIV or HTLV virus infection; Chronic hepatitis C (HCV) treated with direct antiviral drugs; Liver failure; Severe renal failure, including dialysis; Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds; 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; Subject in antineoplastic treatment with chemotherapy or radiation therapy; Subject with severe autoimmune diseases in immunosuppression; Transplanted participants; Pregnant or lactating women; Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitazoxanide<br>Subjects will receive nitazonanide 600 mg TID. | Drug: Nitazoxanide<br>* Subjects will receive nitazonanide 600 mg TID for 7 days<br>* Other names: Viranitta;|
| Placebo Comparator: Placebo<br>Subjects will receive placebo TID. | Drug: Placebo<br>* Subjects will receive placebo TID for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Number of participants with treatment-related adverse events | 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 | 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 | 28 days | 
| Treatment adherence | Subject adherence to treatment will be assessed through study diary record | 7 days | 
| Disease complication | Proportion of patients with severe condition | 28 days | 
| Incidence of subjects that underwent unscheduled visit | Proportion of patient that needed undergo an unscheduled visit | 28 days |