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0 0.5 1 1.5 2+ Mortality 66% Improvement Relative Risk Hospitalization 79% Symp. case 17% Case -21% primary Nitazoxanide  COVER  Prophylaxis  RCT Is prophylaxis with nitazoxanide beneficial for COVID-19? RCT 505 patients in South Africa (December 2020 - January 2022) Lower hospitalization (p=0.5) and fewer symptomatic cases (p=0.49), not sig. Sokhela et al., J. Antimicrobial Chemo.., Aug 2022 Favors nitazoxanide Favors control

Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection

Sokhela et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac266, COVER, NCT04561063
Aug 2022  
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Prophylaxis RCT 828 high-risk participants in South Africa, showing no significant difference with nitazoxanide and sofosbuvir/daclatasvir treatment. FLU-PRO results were available for 74% of the nitazoxanide arm compared to 54% of the control arm.
risk of death, 65.6% lower, RR 0.34, p = 1.00, treatment 0 of 240 (0.0%), control 1 of 265 (0.4%), NNT 265, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of hospitalization, 79.2% lower, RR 0.21, p = 0.50, treatment 0 of 240 (0.0%), control 2 of 265 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of symptomatic case, 17.0% lower, RR 0.83, p = 0.49, treatment 23 of 240 (9.6%), control 37 of 265 (14.0%), incidence rate ratio .
risk of case, 21.0% higher, RR 1.21, p = 0.67, treatment 23 of 240 (9.6%), control 37 of 265 (14.0%), incidence rate ratio , primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sokhela et al., 12 Aug 2022, Randomized Controlled Trial, South Africa, peer-reviewed, median age 24.0, 11 authors, study period December 2020 - January 2022, trial NCT04561063 (history) (COVER).
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Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection
Simiso Sokhela, Bronwyn Bosch, Andrew Hill, Bryony Simmons, Joana Woods, Hilary Johnstone, Godspower Akpomiemie, Leah Ellis, Andrew Owen, Carmen Perez Casas, Willem Daniel Francois Venter
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac266
Background: 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. Methods: 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.
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