The Nitazoxanide Plus Atazanavir for COVID-19 Study

• Status: Completed
• Trial end date: 2021-05-02
• Target enrollment: 0
• Participant gender: All

Summary

Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans.

In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days.

The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Obafemi Awolowo University
• Collaborators: African Centre of Excellence for Genomics of Infectious Diseases; Infectious Disease Hospital Olodo; Obafemi Awolowo University Teaching Hospitals Complex; Olabisi Onabanjo University Teaching Hospital; Osun State Ministry of Health; Oyo State Ministry of Health; University of Liverpool
• Treatments: Atazanavir Sulfate; Nitazoxanide; Ritonavir

Criteria

Inclusion Criteria:

• Willingness and ability to provide written informed consent

• At least 18 and not more than 75 years of age at study entry

• SARS-CoV-2 infection confirmed by PCR test within 4 days before randomization

• Currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia) and at COVID-19 isolation and treatment centre

Exclusion Criteria:

• Inability to take orally administered medication or food

• Known hypersensitivity to study medication

• Pregnant or lactating (unless practicing exclusive replacement feeding for the entire study duration)

• Participation in any other interventional trial for COVID-19 (observational study co-enrollment allowed)

• Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 less than 24 hours prior to study drug dosing

• Concurrent use of agents with known or uncertain interaction with study drugs, including ritonavir

• Requiring mechanical ventilation at screening

• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)

• Creatinine clearance below 50 mL/min using the Cockcroft-Gault formula for participants above 18 years of age