Trial CTRI/2020/04/024729
Publication Thakar A, Indian J Med Res, 2021
Primary outcome on the report: Drug tolerance, clinical and virological metrics. Toxicity assessment was carried out by direct verbal questioning and subsequent investigations as required. General well-being was assessed daily along with the evaluation of the breath-holding time and documentation of the NEWS on days 0, 3, 7 and 10. Nasal swabs were taken on days 0, 3, 7 and 10 and tested by real-time RT-PCR targeting the ORF1ab gene (BGI Genomics Co. Ltd., China) on Agilent AriaMx real-time PCR system.

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: "Computerized generated sequence" (report). "Centralized" (trial registry).
Comment: Allocation sequence random. Allocation sequence concealed.
Deviations from intervention
Some concerns 		Quote: "The microbiological team was blinded to the randomization allocation and also to clinical status."
Comment: Single blind study (outcome assessors).
No participant cross-over.
No information on administration of co-interventions of interest: antivirals, biologics, corticosteroids.
Hence, no information on whether deviation arose because of the trial context.
Data were analyzed using a modified ITT analysis excluding 6 patients in the intervention arm and 5 patients in the control arm that tested negative on day 0 (enrolment errors).
Risk assessed to be some concerns for the outcomes: Incidence of viral negative conversion (D7). Serious adverse events.
Missing outcome data
Low 		Comment: 60 participants randomized; 60 participants analyzed for serious adverse events/49 participants analyzed for viral negative conversion.
Data for more than 5% of the participants was missed for the outcome viral negative conversion.
11 participants were excluded due to enrolment errors (RT-PCR negative at baseline)therefore, we consider that the missingness in the outcome could not depend on its true value, and should not lead to bias.
Risk assessed to be low for the outcomes: Incidence of viral negative conversion (D7).Serious adverse events.
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: Incidence of viral conversion (D7). Serious adverse events.
Selection of the reported results
Some concerns 		Comment: The prospective trial registry was available.
Negative viral conversion 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 outcome: Incidence of viral negative conversion (D7).

No information on whether the result of serious adverse events was selected from multiple outcome measurements or analyses of the data; the outcome was not pre-specified in the trial registry.
Trial may not have been analyzed as pre-specified.
Risk assessed to be some concerns for outcome: Serious adverse events.
Overall risk of bias
Some concerns