Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "A computer-generated randomization scheme with randomly selected block sizes ranging from 3 to 9 managed by a centralized web-based system was used to allocate participants to each group"
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "open-label"
Comment: unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: Antivirals, corticosteroids and biologics(co-interventions of interest) were reported and were balanced between groups. One patient received noninvasive ventilation despite being assigned to the high-flow nasal oxygen group, and 1 patient did not receive helmet noninvasive ventilation because of ventilator unavailability.Deviation too small to affect the outcome. Hence, deviations did not arise because of the trial context. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Clinical Improvement (D28). Clinical Improvement (D60 or more). WHO Score 7 and Above (D28). WHO Score 7 and Above (D60 or more). Time to WHO Score 7 and Above. |
| Missing outcome data |
Low |
Comment: 110 participants randomized; 109 participants analyzed.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Clinical Improvement (D28). Clinical Improvement (D60 or more). WHO Score 7 and Above (D28). WHO Score 7 and Above (D60 or more). Time to WHO Score 7 and Above. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Clinical improvement (D28). Clinical improvement (D60 or more). WHO score 7 and above (D28). WHO score 7 and above (D60 or more). Time to WHO score 7 and above. |
| Selection of the reported results |
Low |
Comment: The protocol was available but not dated, hence not consulted. The statistical analysis plan (dated September 20th, 2020), registry (dated August 3rd, 2020) were prospective and consulted.
Outcomes were pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Outcome data acquired from contact with authors. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Clinical improvement (D28). Clinical improvement (D60 or more). WHO score 7 and above (D28). WHO score 7 and above (D60 or more). Time to WHO score 7 and above. |
| Overall risk of bias |
Some concerns |