Status:
WITHDRAWN
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Farmoquimica S.A.
Conditions:
covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sub...
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04435314
Start Date
June 1 2020
End Date
August 1 2020
Last Update
October 28 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.