Trial *
Publication Khamis F, Int J Infect Dis (2020) (published paper)
Dates: 2020-06-22 to 2020-08-13
Funding: Private (Synairgen Research.)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / Oman Follow-up duration (days): 14 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
FAV+IFN 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 Hydroxychloroquine 400 mg twice a day on day 1, followed by 200 mg twice a day for 7 days |
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Control
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Participants | |
Randomized participants : FAV+IFN beta-1b=44 Hydroxychloroquine=45 | |
Characteristics of participants N= 89 Mean age : NR 52 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR | |
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 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 | 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). |