Trial NCT04351295
Publication Dabbous H, Arch Virol, 2021 (published paper)
Dates: 2020-04-20 to 2020-08-30
Funding: Not reported/unclear
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Egypt Follow-up duration (days): * | |
| Inclusion criteria | Adult 18 to 80 years of age
Confirmed SARS-CoV-2 infection with mild or moderate symptoms Having been admitted to the hospital three days after the onset of symptoms. |
| Exclusion criteria | Allergy or contraindication to the drug
Pregnant and lactating mothers Patients with cardiac problems, liver or renal failure, or other organ failure. |
| Interventions | |
| Treatment
Favipiravir ( / )Co-Intervention: Standard care Duration : |
|
| Control
Chloroquine ( / ) | |
| Participants | |
| Randomized 96 participants (n1=48 / n2= 48) | |
| Characteristics of participants N=96 Mean age : 35.5 45 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Number of patients with mortality or need for mechanical ventilation [ Time Frame: 6 months ] Note: Number of patients with viral cure was in original registry entry, but removed at or near study completion. | |
| In the report Mortality rate and the need for mechanical ventilation | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated No |
| 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 study protocol nor statistical analysis plan was available. The study achieved the target sample size specified in the trial registry. The control arm in the reported study received an active treatment (chloroquine) rather than placebo as was proposed in the registry. The study outcomes in the registry were changed at or near study completion from viral cure to mortality and need for mechanical ventilation. Other outcomes are reported that were not pre-specified in the registry. |