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
Pegylated Interferon alpha-2b 1 mcg/kg subcutaneously once-off |
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Control
Standard care ( / ) Definition of Standard care: Standard of care treatments (i.e., antipyretics, cough suppressants, antibiotics, steroids, vitamins, anticoagulants, hydroxychloroquine and antivirals e.g. remdesivir) were administered as per the COVID-19 clinical management guidelines of the ministry of health, Government of India and the individual institutional practice. | |
Participants | |
Randomized 250 participants (n1=120 / n2= 130) | |
Characteristics of participants N=250 Mean age : 49.9 177 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=250 Critical: n=0 | |
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 stated
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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. |