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

Phase 2

Withdrawn

• Conditions: covid19
• Interventions: Drug: Placebo; Drug: Nitazoxanide

• Registration Number: NCT04435314
• Lead Sponsor: Azidus Brasil

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.

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 Timeline

• Study Start: 2020-06
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive placebo TID.
nitazoxanide	Nitazoxanide	Subjects will receive nitazonanide 600 mg TID.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
Incidence of subjects that underwent unscheduled visit	28 days	Proportion of patient that needed undergo an unscheduled visit