Trial NCT04392973
Publication FACCT - Bosaeed M, Infect Dis Ther (2021) (published paper)
Dates: 2020-05-21 to 2021-01-26
Funding: Public/non profit (King Abdullah International Medical Research Center, Saudi Arabia.)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Saudi Arabia Follow-up duration (days): 90 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
FAV+HCQ Favipavir. Initial dose: 1800 mg orally 2 times a day for 1 day. Maintenance dose: 800 mg orally 2 times a day for 9 days. Hydroxychloroquine. Initial dose: 400 mg 2 times a day for 1 day. Maintenance dose: 200mg 2 times a day for 4 days. |
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Control
Standard care | |
Participants | |
Randomized participants : FAV+HCQ=132 Standard care=136 | |
Characteristics of participants N= 268 Mean age : NR 103 males Severity : Mild: n=19 / Moderate: n=190 / Severe: n=39 Critical: n=6 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Clinical Improvement [ Time Frame: 28 days ] The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. | |
In the report Time to clinical improvement, defined as the time from randomisation to an improvement of two points (from the status at randomisation) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. | |
Documents available |
Protocol Yes. In English Statistical plan Yes 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/pre-print article, the study registry, statistical analysis plan and the protocol were used in data extraction and risk of bias assessment. The study did not achieved the target sample size specified in the trial registry. 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 report are not pre-specified in the registry (e.g. mortality, time to death). Adverse events were reported but not extracted.
On 10th of August, 2021, this study was updated based on the published report. |