A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19.
COVID-19
SARS-CoV-2
atazanavir/ritonavir
nitazoxanide (NTZ)
pharmacokinetics
Journal
Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047
Informations de publication
Date de publication:
2022
2022
Historique:
received:
30
05
2022
accepted:
11
08
2022
entrez:
26
9
2022
pubmed:
27
9
2022
medline:
27
9
2022
Statut:
epublish
Résumé
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. 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). There was no difference in time to clinical improvement between the SoC ( 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. [https://clinicaltrials.gov/ct2/show/NCT04459286], identifier [NCT04459286].
Sections du résumé
Background
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
There was no difference in time to clinical improvement between the SoC (
Conclusion
UNASSIGNED
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
UNASSIGNED
[https://clinicaltrials.gov/ct2/show/NCT04459286], identifier [NCT04459286].
Identifiants
pubmed: 36160134
doi: 10.3389/fmed.2022.956123
pmc: PMC9493023
doi:
Banques de données
ClinicalTrials.gov
['NCT04459286']
Types de publication
Journal Article
Langues
eng
Pagination
956123Informations de copyright
Copyright © 2022 Fowotade, Bamidele, Egbetola, Fagbamigbe, Adeagbo, Adefuye, Olagunoye, Ojo, Adebiyi, Olagunju, Ladipo, Akinloye, Onayade, Bolaji, Rannard, Happi, Owen and Olagunju.
Déclaration de conflit d'intérêts
AnO and SR are Directors of Tandem Nano Ltd. AnO received research funding from ViiV, Merck, Janssen, and consultancy from Gilead, ViiV, and Merck not related to the current manuscript. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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