The Nitazoxanide Plus Atazanavir for COVID-19 Study
Status:
Completed
Trial end date:
2021-05-02
Target enrollment:
Participant gender:
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
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