This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.
This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to
treat hospitalized patients with moderate COVID-19.
The aim is to demonstrate a decrease in hospital related complications among patients who are
hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of
standard care compared to patients who receive standard care and placebo.
Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive
either nitazoxanide or placebo.
Drug: Nitazoxanide Tablets
Patients will receive nitazoxanide 600 mg BID for 7 days
Drug: Placebo
Patients will receive placebo BID for 7 days
Inclusion Criteria:
1. Informed consent from patient or legal representative.
2. Male or female, aged ≥ 18 years;
3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
chain reaction (RT-PCR) from any diagnostic sampling source;
4. Signs of respiratory failure requiring oxygen therapy
5. Hospitalized for up to 36h with non-invasive ventilation
6. Negative result for pregnancy test (if applicable).
Exclusion Criteria:
1. Participating in another RCT in the past 12 months;
2. Known allergy to nitazoxanide
3. Severely reduced LV function;
4. Severely reduced renal function;
5. Pregnancy or breast feeding;
6. Use of hydroxychloroquine and/or azithromycin in the past 15 days;
7. Any other clinical condition which, in the opinion of the principal investigator,
would not allow safe completion of the protocol and safe administration of the
investigational products
Hospital Vera Cruz
Campinas, São Paulo, Brazil
Centro de Genomas
São Paulo, Brazil
Hospital Emílio Ribas
São Paulo, Brazil