Covid-19 Living Data

Trial NCT04387760
Publication AlQahtani M, Sci Rep (2022) (published paper)
Dates: 2020-08-01 to 2021-03-30
Funding: Public/non profit (National Taskforce for combating the Coronavirus (COVID- 19), Ministry of Health Bahrain; the Royal College of Surgeons in Ireland-Bahrain.)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Bahrain Follow-up duration (days): 30
Inclusion criteria	Signed informed consent aged at least 21 years COVID-19 diagnosis based on polymerase chain reaction (PCR) testing symptomatic with any COVID-19 symptoms requiring admission to hospital Hypoxia as defined by an oxygen saturation (SpO2) of more than or equal to 93% on air, or a PaO2 to FiO2 ratio of more than 300 on enrolment.
Exclusion criteria	Severe COVID-19 disease: defined as presence of SpO2 less than 93% on room air or a PaO2 to FiO2 ratio of 300 or lower at time of enrolment Patients on ventilatory support Cardiac dysfunction that would preclude treatment with hydroxychloroquine Renal dysfunction (estimated glomerular filtration rate less than 30 ml/min) Hepatic dysfunction Gout or a history of gout Pregnant or breastfeeding women Patients with a known allergy to an intervention medication Patients with glucose-6-phosphatase deficiency Readmission due to Covid-19 disease Participants in any other COVID-19 disease trial Patients on immunosuppressants, HIV patients, cancer patients who received chemotherapy within the past 6 months, or who were on chronic oral steroids.
Interventions
	Treatment Favipiravir Initial dose: 1600 mg orally twice a day on day 1 - Maintenance dose: 600 mg orally twice a day on days 2 to 10
	Control Standard care
Participants
	Randomized participants : Favipiravir=54 Standard care=52
	Characteristics of participants N= 106 Mean age : NR 50 males Severity : Mild: n=104 / Moderate: n=1 / Severe: n=1 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Medial clinical scale at end of study follow up [Time Frame: Until discharge, death or for a maximum of 30 days or readmission] Median clinical scale at end of study follow up (day 14 or on discharge/death, whichever is earlier)
	In the report The clinical scale at the end of study follow up (day 14 or on discharge/death, whichever is earlier) that was defined as 6 points: death; (5) points: hospitalization plus extracorporeal membrane oxygenation (ECMO) or invasive mechanical ventilation; (4) points: hospitalization plus non-invasive ventilation or high-flow supplemental oxygen; (3) points: hospitalization plus supplemental oxygen (not high-flow or non-invasive ventilation); (2) points: hospitalization with no supplemental oxygen; (1) point: hospital discharge.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Some outcomes from the registry are not reported in the paper (e.g., all adverse events- only discontinuations due to AEs were reported). This is a 3-arm trial incuding an HCQ group; only the Favipiravir vs Standard care comparison is relevant to our review and was extracted.