Trial *
Publication Mahajan L, Indian J Anaesth, 2021 (published paper)
Dates: 2020-06-01 to 2020-12-30
Funding: No specific funding (None)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / India
Follow-up duration (days): 24
Inclusion criteriaHospitalised patients aged between 18 and 60 years age; SARS‑CoV‑2 infection confirmed by polymerase‑chain‑reaction assay within the last 4 days; respiratory rate >24/min; radiographic evidence of pneumonia; oxygen saturation of 94% or less; creatinine clearance above 40 ml per minute.
Exclusion criteriaPatients on mechanical ventilation or with multiorgan failure; serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of the normal range; creatinine clearance below 40 ml per minute.
Interventions
Treatment
Remdesivir
Initial dose: 200 mg IV 3 to 4 times a day for the first 24 hours -Maintenance dose: 100 mg IV once daily for 4 days.
Control
Standard care ( / )
Definition of Standard care: Both treatment groups continued supportive therapy throughout the duration of the study. Other drugs used for COVID treatment (off-label use and in the absence of written policy) were not allowed to be administered to the patients in the study period. Drugs like corticosteroids and heparin were given as per SC protocol.
Participants
Randomized
82 participants (n1=41 / n2= 41)
Characteristics of participants
N=82
Mean age : 57.7
48 males
Severity : Mild: n=0 / Moderate: n=53/ Severe: n=17 Critical: n=0
Primary outcome
In the register
NR
In the report
Improvement in clinical outcomes
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
High
General comment Only the published article was used in data extraction and assessment of the risk of bias. No trial registry, protocol or statistical analysis plan was available. The study sample size was reached. Outcome data assessed as per-protocol analysis. The study was assessed to be at a high risk of bias due to some concerns in four of five domains.