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

• Status: Not yet recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Azidus Brasil
• Collaborator: Farmoquimica S.A.
• Treatments: Nitazoxanide

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;

• 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.