Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Collaborators: Farmoquimica S.A.; Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil
• 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

4. chain reaction (RT-PCR) from any diagnostic sampling source;

5. Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation <98%;

7. 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. Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);

7. History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;

8. Ongoing antineoplastic treatment with chemotherapy or radiation therapy;

9. Diagnose of severe autoimmune diseases in immunosuppression;

10. Transplanted patients;

11. 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