Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Akpomiemie, Godspower, Ellis, Leah, Owen, Andrew 
ORCID: 0000-0002-9819-7651, Casas, Carmen Perez et al (show 1 more authors)
(2022)
Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection.
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 77 (10).
pp. 2706-2712.
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Abstract
<h4>Background</h4>The COVER trial evaluated whether nitazoxanide or sofosbuvir/daclatasvir could lower the risk of SARS-CoV-2 infection. Nitazoxanide was selected given its favourable pharmacokinetics and in vitro antiviral effects against SARS-CoV-2. Sofosbuvir/daclatasvir had shown favourable results in early clinical trials.<h4>Methods</h4>In this clinical trial in Johannesburg, South Africa, healthcare workers and others at high risk of infection were randomized to 24 weeks of either nitazoxanide or sofosbuvir/daclatasvir as prevention, or standard prevention advice only. Participants were evaluated every 4 weeks for COVID-19 symptoms and had antibody and PCR testing. The primary endpoint was positive SARS-CoV-2 PCR and/or serology ≥7 days after randomization, regardless of symptoms. A Poisson regression model was used to estimate the incidence rate ratios of confirmed SARS-CoV-2 between each experimental arm and control.<h4>Results</h4>Between December 2020 and January 2022, 828 participants were enrolled. COVID-19 infections were confirmed in 100 participants on nitazoxanide (2234 per 1000 person-years; 95% CI 1837-2718), 87 on sofosbuvir/daclatasvir (2125 per 1000 person-years; 95% CI 1722-2622) and 111 in the control arm (1849 per 1000 person-years; 95% CI 1535-2227). There were no significant differences in the primary endpoint between the treatment arms, and the results met the criteria for futility. In the safety analysis, the frequency of grade 3 or 4 adverse events was low and similar across arms.<h4>Conclusions</h4>In this randomized trial, nitazoxanide and sofosbuvir/daclatasvir had no significant preventative effect on infection with SARS-CoV-2 among healthcare workers and others at high risk of infection.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Carbamates, Nitro Compounds, Imidazoles, Pyrrolidines, Thiazoles, Valine, Antiviral Agents, Treatment Outcome, South Africa, Sofosbuvir, COVID-19, SARS-CoV-2 |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 28 Oct 2022 15:04 |
| Last Modified: | 18 Jan 2023 19:48 |
| DOI: | 10.1093/jac/dkac266 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3165852 |
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