NCT04459286: NACOVID

The Nitazoxanide Plus Atazanavir for COVID-19 Study

Terminated Phase 2 Last updated 2 March 2022

What this trial tests

Phase 2 trial testing Nitazoxanide and atazanavir/ritonavir in Covid-19 in 57 participants. Terminated before completion.

Timeline

9 October 2020

Primary endpoint
2 May 2021

2 May 2021

Quick facts

Lead sponsor	Obafemi Awolowo University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	57
Start date	9 October 2020
Primary completion	2 May 2021
Estimated completion	2 May 2021
Sites	2 locations across Nigeria

Drugs / interventions tested

• Nitazoxanide and atazanavir/ritonavir — full drug profile →
• Standard of Care

Conditions studied

• Covid-19 — all drugs for Covid-19 →

Sponsor

Obafemi Awolowo University

Who can join

Adults 18 to 75, any sex, with Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
2. Potential drug targets of SARS-CoV-2: From genomics to therapeutics.
   Shamsi A, Mohammad T, Anwar S, Amani S, et al · · 2021 · cited 73× · PMID 33577820 · DOI 10.1016/j.ijbiomac.2021.02.071
3. A review on possible mechanistic insights of Nitazoxanide for repurposing in COVID-19.
   Lokhande AS, Devarajan PV. · · 2021 · cited 69× · PMID 33227285 · DOI 10.1016/j.ejphar.2020.173748
4. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial.
   Blum VF, Cimerman S, Hunter JR, Tierno P, et al · · 2021 · cited 50× · PMID 34222847 · DOI 10.1016/j.eclinm.2021.100981
5. Potential Anti-SARS-CoV-2 Therapeutics That Target the Post-Entry Stages of the Viral Life Cycle: A Comprehensive Review.
   Al-Horani RA, Kar S. · · 2020 · cited 33× · PMID 32993173 · DOI 10.3390/v12101092
6. Chemical biology and medicinal chemistry of RNA methyltransferases.
   Fischer TR, Meidner L, Schwickert M, Weber M, et al · · 2022 · cited 29× · PMID 35412633 · DOI 10.1093/nar/gkac224
7. Anti-viral treatment for SARS-CoV-2 infection: A race against time amidst the ongoing pandemic.
   Vallianou NG, Tsilingiris D, Christodoulatos GS, Karampela I, et al · · 2021 · cited 28× · PMID 34056571 · DOI 10.1016/j.metop.2021.100096
8. Antiretroviral drug activity and potential for pre-exposure prophylaxis against COVID-19 and HIV infection.
   Copertino DC, Casado Lima BC, Duarte RRR, Powell TR, et al · · 2022 · cited 21× · PMID 33734021 · DOI 10.1080/07391102.2021.1901144