Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

• Status: Recruiting
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Collaborators: Centro de Genomas - UNIFESP; Emilio Ribas Institute of Infectious Diseases; Farmoquimica S.A.; Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil; Hospital Vera Cruz
• Treatments: Nitazoxanide

Criteria

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