Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease
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.
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, 13 authors, study period August 2020 - March 2021, trial NCT04387760 (history)
Randomized controlled trial
of favipiravir, hydroxychloroquine,
and standard care in patients
with mild/moderate COVID‑19
Manaf AlQahtani1,2,3*, Nitya Kumar3, Dhuha Aljawder4, Abdulkarim Abdulrahman1,5,
Fatema Alnashaba4, Mohammed Abu Fayyad3, Faisal Alshaikh2, Fatima Alsahaf4,
Sawsan Saeed3, Amal Almahroos4, Zainab Abdulrahim4, Sameer Otoom3 & Stephen L. Atkin3
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
Clinical trials registration. NCT04387760. Registration date: 07/05/2020.
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARSCoV-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
deaths1. Several vaccines have been shown to prevent or ameliorate COVID-19 disease, and several are currently
developing2. 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 SARSCoV-23. 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 Use4.
Hydroxychloroquine was thought to show great promise at the time that this study was initiated5 but, in a large
observational study, showed no differences in rates of intubation or d
eath6, and a randomized trial in 150 patients
showed mild beneficial effects7. A subsequent report indicated that postexposure therapy..
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, 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
provide treatment protocols.