| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote from the protocol: "The study will randomize participants 1:1 to placebo or investigational product. If additional arms are added to or dropped from the trial, randomization will proceed with an equal probability of assignment to each of the remaining arms. Randomization will be stratified by: Site; Severity of illness at enrollment (Severe disease: requiring mechanical ventilation or oxygen, a SpO2 ? 94% on room air, or tachypnea (respiratory rate ? 24 breaths/min); Mild-moderate disease: SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen)." "Enrollment and randomization of subjects is done online using the enrollment module of Advantage eClinical®. Eligible subjects will be randomized and assigned in a 1:1 ratio to either remdesivir or placebo, with stratification by site and disease severity (Mild/Moderate disease or Severe disease). The randomization is based on a variable blocked scheme to provide an approximately balanced allocation to the treatment groups during the study. If arms are added or removed later in the study, randomization will continue in an equal allocation manner." |
| Deviations from intervention |
Some concerns |
Quote: "The treatment will be prepared by the licensed pharmacist and administered by an unblinded
study nurse. All follow-up safety and efficacy evaluations will be performed by blinded clinic
staff." Comment: Patients were blinded. The staff administering the intervention was not blinded. There inadequate information to assess whether co-intervention receipt was balanced between the two arms. Data were analyzed by using intent-to-treat analysis. |
| Missing outcome data |
Low |
The results are preliminary and only 391/541 remdesivir patients and 340/522 of the placebo group had completed the trial through day 29. The results at D14 were rated low risk of bias for the missing outcome domain since all patients did complete their 14 days follow-up. No results were reported for the D28 follow-up so we did not assess RoB at D28. |
| Measurement of the outcome |
Low |
Quote: "All follow-up safety and efficacy evaluations will be performed by blinded clinic staff". Risk assessed to be low for the outcomes:Mortality. WHO Clinical progression scale score 6 or above. WHO Clinical progression scale score 7 or above. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: the protocol was available. The statistical analysis plan was not available. Risk assessed to be low for the outcomes: Mortality. WHO scale score 6 and above. WHO scale score 7 and above. Serious adverse events. |
| Overall risk of bias |
Some concerns |