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Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial

Chandiwana et al., eBioMedicine, doi:10.1016/j.ebiom.2022.104322, NCT04532931
Nov 2022  
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Progression -13% Improvement Relative Risk Time to WHO zero score -23% Viral clearance -67% Favipiravir  Chandiwana et al.  EARLY TREATMENT  RCT Is early treatment with favipiravir + nitazoxanide beneficial for COVID-19? RCT 76 patients in South Africa (September 2020 - August 2021) Slower recovery (p=0.42) and worse viral clearance (p=0.13), not sig. c19early.org Chandiwana et al., eBioMedicine, November 2022 Favorsfavipiravir Favorscontrol 0 0.5 1 1.5 2+
Very high COI low-risk patient RCT in South Africa, showing no significant differences with favipiravir plus nitazoxanide. There were no deaths and no COVID-19 hospitalizations for favipiravir plus nitazoxanide. More patients were seropositive at baseline in the treatment arm (28% vs 22%). Favipiravir 1600mg 12-hourly for 1 day, then 600mg 12-hourly for 6 days. Nitazoxanide 1000mg 12-hourly for 7 days.
Study covers nitazoxanide and favipiravir.
risk of progression, 13.0% higher, OR 1.13, p = 0.89, treatment 37, control 39, adjusted per study, day 28, Table S9, RR approximated with OR.
time to WHO zero score, 23.5% higher, HR 1.23, p = 0.42, treatment 37, control 39, inverted to make HR<1 favor treatment, Cox proportional hazards, Table S10.
risk of no viral clearance, 66.7% higher, RR 1.67, p = 0.13, treatment 27 of 37 (73.0%), control 25 of 38 (65.8%), adjusted per study, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chandiwana et al., 1 Nov 2022, Randomized Controlled Trial, South Africa, peer-reviewed, mean age 34.9, 16 authors, study period 3 September, 2020 - 23 August, 2021, this trial uses multiple treatments in the treatment arm (combined with nitazoxanide) - results of individual treatments may vary, trial NCT04532931 (history). Contact: nchandiwana@ezintsha.org.
This PaperFavipiravirAll
Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial
Nomathemba Chandiwana, Chelsea Kruger, Hilary Johnstone, Mohamed Farouk Chughlay, Chung Ju, Byungsu Kim, Yengiwe Dineka, Sarah Arbe-Barnes, Robert Miller, Andrew Owen, Andrew Hill, Daniel Windgassen, Nada Abla, Anne Claire Marrast, Stephan Duparc, Willem Daniel Francois Venter
eBioMedicine, doi:10.1016/j.ebiom.2022.104322
Background This exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19. Methods This phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd September 2020 and 23rd August 2021. Symptomatic outpatients aged 18-65 years, with RT-PCR confirmed SARS-CoV-2 infection were computer randomised (1:1:1:1:1) to standard-of-care (SOC) with paracetamol, or SOC plus artesunate-amodiaquine (ASAQ), pyronaridine-artesunate (PA), favipiravir plus nitazoxanide (FPV + NTZ), or sofosbuvir-daclatasvir (SOF-DCV). The primary endpoint was the incidence of viral clearance, i.e., the proportion of patients with a negative SARS-CoV-2 RT-PCR on day 7, compared to SOC using a log-binomial model in the modified intention-to-treat (mITT) population. Findings The mITT population included 186 patients: mean age (SD) 34.9 (10.3) years, body weight 78.2 (17.1) kg. Day 7 SARS-CoV-2 clearance rates (n/N; risk ratio [95% CI]) were: SOC 34.2% (13/38), ASAQ 38.5% (15/39; 0.80 [0.44, 1.47]), PA 30.3% (10/33; 0.69 [0.37, 1.29]), FPV + NTZ 27.0% (10/37; 0.60 [0.31, 1.18]) and SOF-DCV 23.5% (8/34; 0.47 [0.22, 1.00]). Three lower respiratory tract infections occurred (PA 6.1% [2/33]; SOF-DCV 2.9% [1/34]); two required hospitalisation (PA, SOF-DCV). There were no deaths. Adverse events occurred in 55.3% (105/190) of patients, including one serious adverse event (pancytopenia; FPV + NTZ). Interpretation There was no statistical difference in viral clearance for any regimen compared to SOC. All treatments were well tolerated.
Appendix A. Supplementary data Supplementary data related to this article can be found at https://doi. org/10.1016/j.ebiom.2022.104322.
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