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Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease

AlQahtani et al., Scientific Reports, doi:10.1038/s41598-022-08794-w, NCT04387760
Mar 2022  
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ICU admission 24% Improvement Relative Risk Recovery 4% Viral clearance 47% HCQ  AlQahtani et al.  LATE TREATMENT  RCT Is late treatment with HCQ beneficial for COVID-19? RCT 103 patients in Bahrain (August 2020 - March 2021) Improved viral clearance with HCQ (not stat. sig., p=0.13) c19hcq.org AlQahtani et al., Scientific Reports, Mar 2022 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19hcq.org
RCT with 54 favipiravir, 51 HCQ, and 52 SOC hospitalized patients in Bahrain, showing no significant differences. Viral clearance improved with both treatments, but did not reach statistical significance with the small sample size.
Study covers HCQ and favipiravir.
risk of ICU admission, 23.5% lower, RR 0.76, p = 1.00, treatment 3 of 51 (5.9%), control 4 of 52 (7.7%), NNT 55.
risk of no recovery, 4.1% lower, RR 0.96, p = 0.94, treatment 5 of 49 (10.2%), control 5 of 47 (10.6%), NNT 230.
risk of no viral clearance, 47.4% lower, RR 0.53, p = 0.13, treatment 7 of 38 (18.4%), control 14 of 40 (35.0%), NNT 6.0.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
AlQahtani et al., 23 Mar 2022, Randomized Controlled Trial, Bahrain, peer-reviewed, 14 authors, study period August 2020 - March 2021, trial NCT04387760 (history).
This PaperHCQAll
Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease
Manaf Alqahtani, Nitya Kumar, Dhuha Aljawder, Abdulkarim Abdulrahman, Mohammed Wael Mohamed, Fatema Alnashaba, Mohammed Abu Fayyad, Faisal Alshaikh, Fatima Alsahaf, Sawsan Saeed, Amal Almahroos, Zainab Abdulrahim, Sameer Otoom, Stephen L Atkin
Scientific Reports, doi:10.1038/s41598-022-08794-w
Favipiravir has antiviral activity against influenza, West Nile virus, and yellow fever virus and against flaviviruses. The objective of this pilot study was to compare three arms: favipiravir; hydroxychloroquine; standard care (no specific SARS-CoV-2 treatment) only, in symptomatic patients infected by SARS-CoV-2 in an open-labelled randomized clinical trial. The trial was registered with Bahrain National Taskforce for Combatting COVID-19 on the 7th of May 2020 (registration code: NCT04387760). 150 symptomatic patients with COVID-19 disease were randomized into one of three arms: favipiravir, hydroxychloroquine, or standard care only. The primary outcome was the clinical scale at the end of study follow up (day 14 or on discharge/death) based on a points scale. The secondary outcomes were viral clearance, biochemical parameter changes and mortality at 30-days. Baseline characteristics did not differ between groups. The proportion of patients who achieved a clinical scale < 2 did not differ between groups. The favipiravir-treated and hydroxychloroquine-treated group showed increased viral clearance (OR, 95%CI 2.38, 0.83-6.78, OR, 95%CI 2.15, 0.78-5.92, respectively) compared to standard care, but this was not significant. The biochemical profile did not differ between groups, except for the platelet count (P < 0.03) and uric acid (P < 0.004) that were higher with favipiravir-treatment. Primary or secondary outcome measures did not differ between favipiravir, hydroxychloroquine, and standard therapy for mild to moderate COVID-19 disease; therefore, whilst favipiravir therapy appeared safe with a trend to increased viral clearance, there was no superior therapeutic utility. Clinical trials registration. NCT04387760. Registration date: 07/05/2020. Coronavirus disease 2019 (COVID-19 ) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and has developed into a pandemic with serious global public health and economic sequelae. As of May 30th, 2021, more than 170,695,962 million cases have been confirmed worldwide, leading to over 3,550,234 deaths 1 . Several vaccines have been shown to prevent or ameliorate COVID-19 disease, and several are currently developing 2 . However, for those that establish COVID-19 disease, there is a need for effective therapeutic agents to prevent the progressive deterioration that may be seen. There have been several reports of medications, such as remdesivir, with antiviral properties that have shown efficacy with shorter time-to-recovery against SARS-CoV-2 3 . It has been suggested that corticosteroids should be used cautiously unless there is evidence of refractory septic shock, acute respiratory distress syndrome (ARDS), or another compelling indication for their Use 4 . Hydroxychloroquine was thought to show great promise at the time that this study was initiated 5 but, in a large observational study, showed no differences in rates of intubation or death 6 , and a randomized trial..
Author contributions N.K.: data analysis, interpretation and preparation of the manuscript; D.A., A.A., F.A., M.A.F., F.A., F.A., S.S., A.A., Z.A., S.O. & S.A.: conception and design, data collection, manuscript review; S.S., N.K. & S.L.A.: writing and manuscript review; M.A.Q.: conception and design of the study and manuscript review. Competing interests The authors declare no competing interests. Additional information Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1038/ s41598-022-08794-w. Correspondence and requests for materials should be addressed to M.A. Reprints and permissions information is available at www.nature.com/reprints. Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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