Trial CTRI/2020/06/026087
Publication Pandit A, Int J Infect Dis (2021) (published paper)
Dates: 2020-07-08 to 2020-09-04
Funding: Private (Cadila Healthcare Limited)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / India Follow-up duration (days): 29 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Interferon alpha-2b 1 mcg/kg subcutaneous injection, single dose |
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Control
Standard care | |
Participants | |
Randomized participants : Interferon alpha-2b=20 Standard care=20 | |
Characteristics of participants N= 40 Mean age : NR 30 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Evaluation of the clinical efficacy of Pegylated IFN-?2b on the basis of change in ordinal scale | |
In the report Clinical status assessed on day 15 on a WHO 7-point ordinal scale consisting of the following categories: 1, not hospitalized, no limitations of activities; 2, not hospitalized, limitation on activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, on non-invasive ventilation or high flow oxygen devices; 6, hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 7, death | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported |
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 study registry was used in data extraction and risk of bias assessment. No study protocol or statistical analysis plan was available. The study achieved its prespecified target sample size. Some secondary outcomes were not pre-specified including occurrence and duration of supplemental oxygen and mechanical ventilation, duration of hospitalization, change from baseline in white blood cell count (WBC), hemoglobin (Hb), platelets, creatinine, glucose, total bilirubin, ALT and AST, and change from baseline in CRP, IL-6, D-dimer, interferon-g, ferritin, TNF-α, and IL-1β until Day 14. The primary outcome (i.e., clinical improvement) was only reported at one of two pre-specified timepoints (i.e., reported at day 15 but not day 30). The published article specifies administration of a single dose of the intervention which differs from the two doses (day 1 and day 8) specified in the registry. |