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 criteriaAge ≥18 years ; RT-PCR confirmed SARSCoV-2 infection ; pneumonia with no signs of severe disease ; respiratory rate 15–30 breaths/min ; SpO2 90%–94% ; for female patients of child-bearing potential, a negative pregnancy test prior to treatment ; C-reactive protein (CRP) < 16 mg/L ; IL-6 < 100 pg/mL ; D-dimer < 2 mg/mL ; interferon-g, ferritin, tumor necrosis factor (TNF)-α, IL-1β greater than an upper limit of normal (ULN) ; illness of any duration and radiographic infiltrates by chest X-ray or evidence of rales/crackles or other clinical symptoms on clinical examination.
Exclusion criteriaAlanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 x ULN; stage 4 severe chronic kidney disease or required dialysis (i.e., estimated glomerular filtration rate <30 mL/min/1.73 m2); pregnant or breast-feeding women; severe co-morbidity (e.g., uncontrolled hypertension, uncontrolled diabetes mellitus, systemic disease which had affected the vital organs severely, immunocompromised patients, etc.); comorbid condition like myocardial infarction or heart failure within 90 days of recruitment; prolonged QT interval (>450 ms).
Interventions
Treatment
Pegylated Interferon alpha-2b
1 mcg/kg subcutaneous injection, single dose
Control
Standard care ( / )
Definition of Standard care: The regulatory recommendations (Clinical Management Protocol: COVID-19 [Ministry of Health and Family Welfare,2020]) have been followed to categorize moderate COVID19 subjects and treatment accordingly. During the study, all the investigators agreed to provide standard care to all the subjects. Antipyretics, cough suppressants, antibiotics, steroids, vitamins, anticoagulants, and hydroxychloroquine were administered as per regulatory recommendation and approval.
Participants
Randomized
40 participants (n1=20 / n2= 20)
Characteristics of participants
N=40
Mean age : 49.2
30 males
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0
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 stated

NR
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.