Trial CTRI/2021/04/033263
Publication Naik NB, Cureus (2021) (published paper)
Dates: 2021-05-06 to 2021-06-30
Funding: Public/non profit (Source of monetary of material support - Post Graduate Institute of Medical Education and Research)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Single center / India
Follow-up duration (days): 28
Inclusion criteria
  • 18 years and older
  • confirmed SARS-CoV-2 infection by reverse-transcriptase polymerase chain reaction (RT-PCR) assay
  • partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ratio of less than 200 on admission and receiving standard care
  • clinical worsening in less than 48 hours of the initiation of standard care (Clinical worsening was defined as follows: (1) decrease in PaO2/FiO2 by more than 50 of the baseline admission value, (2) oxygenation/ventilation device is upgraded, and (3) static or rising levels of C-reactive protein (CRP > 50 mg/L))
Exclusion criteria
  • prior history of immunosuppression and use of immunosuppressive drugs, raised septic biomarkers suggestive of invasive bacterial or fungal infection, AST/ALT ≥ five times the upper limit of normal, leukocytes < 2 × 103/μL, thrombocytes < 50 × 103/μL, and acute or chronic diverticulitis
Interventions
Treatment
Tocilizumab
6 mg/kg intravenously once-off. An additional similar dose after 24 hours if no clinical improvement.
Control
Dexamethasone
20 mg intravenously once daily for 3 days

Participants
Randomized
participants :
Dexamethasone=21
Tocilizumab=21
Characteristics of participants
N= 42
Mean age : NR
24 males
Severity : Mild: n=0 / Moderate: n=36 / Severe: n=6 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Ventilator free days (VFD) Timepoint: 0-28days following admission.
In the report
Ventilator-free days (VFDs) within 28 days since randomization.
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 trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Only graphical summaries of the protocol and statistical analysis plan were available. The study was terminated at the interim analysis stage due to increased mortality and adverse event rate observed in the high dose dexamethasone arm and therefore did not achieve the target sample size (n=42 of planned n=102). The primary outcome indicated in registry reflects the primary outcome reported in the paper. There is no change from the trial registration in the intervention and control treatments.