Covid-19 Living Data

Trial CTRI/2020/12/029855
Publication Bhushan S, Int J Infect Dis (2021) (published paper)
Dates: 2020-12-16 to 2021-03-25
Funding: Private (Cadila Healthcare Ltd.)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / India Follow-up duration (days): 29
Inclusion criteria	Age ≥18 years RT-PCR confirmed SARS-CoV-2 infection pneumonia with no signs of severe disease respiratory rate (RR) ≥24 breaths/minute SpO2 90% to 94% for female patients of child-bearing potential, a negative pregnancy test. All subjects were hospitalized.
Exclusion criteria	ALT/AST >5 times the upper limit of normal. Stage 4 severe chronic kidney disease or required dialysis (i.e. eGFR <30) Pregnant or breast feeding Allergy to any study medication Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which was affected the vital organs severity, immunocompromised patients etc.) as per investigator’s assessment Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment Prolong QT interval (>450 ms).
Interventions
	Treatment Interferon alpha-2b 1 mcg/kg subcutaneously once-off
	Control Standard care
Participants
	Randomized participants : Interferon alpha-2b=120 Standard care=130
	Characteristics of participants N= 250 Mean age : NR 177 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=250 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Change in ordinal scale at Day 11 ± 1.
	In the report Change in ordinal scale at day 11 (two-point improvement in the WHO 7-point ordinal scale)
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 prospective trial registry and supplementary materials were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The study achieved its target sample size. There is no change from the trial registration in the intervention and control treatments. The primary outcome reported reflects that in the registry. SAE was an outcome in the registry; two deaths are reported in the safety outcomes section, but it is not clear whether these were the only SAEs. Other than that, the secondary outcomes reported reflect those in the registry. Four of five risk of bias domains were assessed to have some concerns. Commonly, this would be a reason to elevate the study overall to high risk of bias, but no individual outcome was some concerns in more than three domains.