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.
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.
Drug: Nitazoxanide
Subjects will receive nitazonanide 600 mg TID for 7 days
Other Name: Viranitta
Drug: Placebo
Subjects will receive placebo TID for 7 days.
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.
Reginaldo Raimundo Fujita, Principal Investigator
Federal University of São Paulo