Dataset Information

A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19.

ABSTRACT:

Background

The nitazoxanide plus atazanavir/ritonavir for COVID-19 (NACOVID) trial investigated the efficacy and safety of repurposed nitazoxanide combined with atazanavir/ritonavir for COVID-19.

Methods

This is a pilot, randomized, open-label multicenter trial conducted in Nigeria. Mild to moderate COVID-19 patients were randomly assigned to receive standard of care (SoC) or SoC plus a 14-day course of nitazoxanide (1,000 mg b.i.d.) and atazanavir/ritonavir (300/100 mg od) and followed through day 28. Study endpoints included time to clinical improvement, SARS-CoV-2 viral load change, and time to complete symptom resolution. Safety and pharmacokinetics were also evaluated (ClinicalTrials.gov ID: NCT04459286).

Results

There was no difference in time to clinical improvement between the SoC (n = 26) and SoC plus intervention arms (n = 31; Cox proportional hazards regression analysis adjusted hazard ratio, aHR = 0.898, 95% CI: 0.492-1.638, p = 0.725). No difference was observed in the pattern of saliva SARS-CoV-2 viral load changes from days 2-28 in the 35% of patients with detectable virus at baseline (20/57) (aHR = 0.948, 95% CI: 0.341-2.636, p = 0.919). There was no significant difference in time to complete symptom resolution (aHR = 0.535, 95% CI: 0.251-1.140, p = 0.105). Atazanavir/ritonavir increased tizoxanide plasma exposure by 68% and median trough plasma concentration was 1,546 ng/ml (95% CI: 797-2,557), above its putative EC₉₀ in 54% of patients. Tizoxanide was undetectable in saliva.

Conclusion

Nitazoxanide co-administered with atazanavir/ritonavir was safe but not better than standard of care in treating COVID-19. These findings should be interpreted in the context of incomplete enrollment (64%) and the limited number of patients with detectable SARS-CoV-2 in saliva at baseline in this trial.

Clinical trial registration

[https://clinicaltrials.gov/ct2/show/NCT04459286], identifier [NCT04459286].

SUBMITTER: Fowotade A

PROVIDER: S-EPMC9493023 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19.

Fowotade Adeola A Bamidele Folasade F Egbetola Boluwatife B Fagbamigbe Adeniyi F AF Adeagbo Babatunde A BA Adefuye Bolanle O BO Olagunoye Ajibola A Ojo Temitope O TO Adebiyi Akindele O AO Olagunju Omobolanle I OI Ladipo Olabode T OT Akinloye Abdulafeez A Onayade Adedeji A Bolaji Oluseye O OO Rannard Steve S Happi Christian C Owen Andrew A Olagunju Adeniyi A

Frontiers in medicine 20220908

<h4>Background</h4>The nitazoxanide plus atazanavir/ritonavir for COVID-19 (NACOVID) trial investigated the efficacy and safety of repurposed nitazoxanide combined with atazanavir/ritonavir for COVID-19.<h4>Methods</h4>This is a pilot, randomized, open-label multicenter trial conducted in Nigeria. Mild to moderate COVID-19 patients were randomly assigned to receive standard of care (SoC) or SoC plus a 14-day course of nitazoxanide (1,000 mg b.i.d.) and atazanavir/ritonavir (300/100 mg od) and fo ...[more]

PMID: 36160134

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Dataset Information

A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19.

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