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A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19
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 moder...
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| Format: | Article |
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2022
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| LEADER | 00000njm a2000000a 4500 | ||
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| 001 | oai:repository.ui.edu.ng:123456789/13138 | ||
| 042 | |a dc | ||
| 720 | |a Fowotade, A. |e author | ||
| 720 | |a Bamidele, F. |e author | ||
| 720 | |a Egbetola, B. |e author | ||
| 720 | |a Fagbamigbe, A. F. |e author | ||
| 720 | |a Adeagbo, B. A. |e author | ||
| 720 | |a Adefuye, B. O. |e author | ||
| 720 | |a Olagunoye, A. |e author | ||
| 720 | |a Ojo, T. O. |e author | ||
| 720 | |a Adebiyi, A. O. |e author | ||
| 720 | |a Olagunju, O. I. |e author | ||
| 720 | |a Ladipo, O. T. |e author | ||
| 720 | |a Akinloye, A. |e author | ||
| 720 | |a Onayade, A. |e author | ||
| 720 | |a Bolaji, O. O. |e author | ||
| 720 | |a Rannard, S. |e author | ||
| 720 | |a Happi, C. |e author | ||
| 720 | |a Owen, A. |e author | ||
| 720 | |a Olagunju, A. |e author | ||
| 260 | |c 2022 | ||
| 520 | |a 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-CoV2 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. | ||
| 024 | 8 | |a 2296-858X | |
| 024 | 8 | |a ui_art_fowotade_randomized_2022 | |
| 024 | 8 | |a Frontiers in Medicine 9(956123), pp. 1-19 | |
| 024 | 8 | |a https://repository.ui.edu.ng/handle/123456789/13138 | |
| 653 | |a Nitazoxanide | ||
| 653 | |a Atazanavir/ritonavir | ||
| 653 | |a COVID-19 | ||
| 653 | |a Randomized clinical trial | ||
| 245 | 0 | 0 | |a A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19 |