Covid-19 Living Data

Trial NCT04818320
Publication Chuah CH, Clin Infect Dis (2021) (published paper)
Dates: 2021-02-01 to 2021-06-20
Funding: No specific funding
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Malaysia Follow-up duration (days): 28
Inclusion criteria	Hospitalized patients hospitalized within the first 7 days from symptom onset RT-PCR confirmed COVID-19 infection mild to moderate clinical severity aged ≥50 years old ≥1 known co-morbidity for disease progression (diabetes, hypertension, chronic kidney disease, chronic cardiac disease, chronic pulmonary diseases, asthma, chronic liver disease, chronic neurological disorder, obesity (BMI ≥30kg/m2 ), active smoker, immunocompromised state and malignancy). Based on national guideline, mild severity refers to symptomatic COVID-19 patients without evidence of pneumonia (stage 2), while moderate severity refers to symptomatic patients with evidence of pneumonia (stage 3).
Exclusion criteria	Asymptomatic infection or reinfection patients needing oxygen supplementation pulse oximetry of oxygenation (SpO2) 10 times of upper normal limit) impaired kidney function (creatinine clearance <30 ml/min) history of gout or on treatment for gout or hyperuricemia malabsorption syndrome pregnant or breastfeeding women and patients who received interferon or drugs with reported antiviral activity against COVID-19 within 7 days of illness.
Interventions
	Treatment Favipiravir Initial dose: 1800 mg orally twice a day on day 1 - Maintenance dose" 800 mg orally twice a day days 2-5
	Control Standard care
Participants
	Randomized participants : Standard care=250 Favipiravir=250
	Characteristics of participants N= 500 Mean age : NR 242 males Severity : Mild: n=249 / Moderate: n=251 / Severe: n=0 Critical: n=0 Number of vaccinated participants: 2
Primary outcome
	In the register Need for oxygen supplement [ Time Frame: Day of discharge/day 28 of treatment (if still hospitalized) ] Drop in SPO2 in room air to <95% or requiring supplemental oxygen to maintain SPO2≥95%
	In the report Desaturated with SpO2 <95% on room air, or requiring supplemental oxygen to maintain SpO2 ≥95%
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
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 retrospective trial registry, protocol, statistical analysis plan, data from contact with authors and supplementary appendices were used in data extraction and assessment of risk of bias. The primary and secondary outcomes in the article reflect those in the registry. There is no information on whether the outcomes, target sample size or analyses were determined a priori. The trial (n = 500) achieved its target sample size (n = 500). On April 4th, 2022, the extraction and ROB were updated based on information obtained from contact with authors.