Covid-19 Living Data

Trial *
Publication Khamis F, Int J Infect Dis, 2020 (published paper)
Dates: 2020-06-22 to 2020-08-13
Funding: No specific funding (No funding was received for this study)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Oman Follow-up duration (days): 14
Inclusion criteria	Age between 18-75 years, confirmed SARS-CoV-2 infection by RT-PCR test on respiratory tract specimens, moderate to severe COVID-19 pneumonia according to the WHO interim guidelines case definitions (WHO/2019 nCoV/ Surveillance Case Definition /2020.1), the interval between symptoms onset and randomization is no >10 days; for female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test, eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment; not participating in any other interventional drug clinical study before completion of the present one.
Exclusion criteria	Age above 75, refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of favipiravir; severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the upper limit normal ; gout or history of gout or hyperuricemia; known severe renal impairment with creatinine clearance (CrCl) of <30 mL/min or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis , known allergy or hypersensitivity to favipiravir or pregnant or lactating women.
Interventions
	Treatment Favipiravir+Interferon beta-1b Favipiravir: 1600 mg orally on day 1 followed by 600 mg twice a day for maximum 10 days. Interferon beta-1b: 8 million IU through a vibrating mesh aerogen nebulizer twice a day for 5 days
	Control Hydroxychloroquine (200 mg) Duration : 7 days
Participants
	Randomized 89 participants (n₁=44 / n₂= 45)
	Characteristics of participants N=89 Mean age : 55 52 males Severity : Mild: n=0 / Moderate: n=/ Severe: n= Critical: n=0
Primary outcome
	In the register NR
	In the report The primary endpoints measures were time from assignment to clinical recovery, the normalization of inflammatory markers and improvement in oxygen saturation that is maintained for at least 72 hours.
Documents available	Protocol NR Statistical plan NR Data-sharing stated NR
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	Only the available version of the publidshed article was used in data extraction and risk of bias assessment. Neither the sudy registry, nor the protocol or statistal analysis plan were available. The target sample size specified in the paper was not achieved (the report is described as an interim analysis).