Trial NCT04678739
Publication Mohiuddin Chowdhury ATM, Front pharmacol (2022) (published paper)

Funding: Not reported/unclear
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Bangladesh
Follow-up duration (days): 42
Inclusion criteria
  • Positive RT-PCR for SARS-CoV-2 infection
  • required admission in the ICU
  • National Early Warning Score-2 (NEWS-2) ≥5
Exclusion criteria
  • Pre-existing uncontrolled chronic condition with major compromised organ function before COVID-19 (severe ischemic heart disease, epilepsy, advanced pulmonary/renal/hepatic disease, corpulmonale, long-standing severe uncontrolled DM, etc.)
  • immunocompromised
  • advanced stage of carcinoma
  • in chemo or adjuvant therapy
  • pregnant patients
  • AIDS
  • pulmonary tuberculosis, contraindications/possible drug interactions to remdisivir/tocilizumab/dexamethasone
  • already hospitalized at the time of enrollment due to other causes
  • required ventilator support
Interventions
Treatment
Tocilizumab+Remdesivir
Tocilizumab: 8 mg/kg up to 800 mg IV infusion 12 h apart
Remdesivir 5 mg/kg (<40 kg) or 200 mg (>40 kg) by IV infusion on day 1 and then 2.5 mg/kg (<40 kg) or 100 mg (>40 kg) daily
Control
Dexamethasone
6 mg/day in divided dose

Participants
Randomized
participants :
Tocilizumab+Remdesivir=104
Dexamethasone=104
Characteristics of participants
N= 208
Mean age : NR
156 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=205 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of
In the report
Primary outcome was unclear. "Treatment outcomes were measured as follows: time to clinical improvement, defined as the time from randomization to NEWS-2 score (National Early Warning Score 2) of ≤2 as maintained for 24 h; mortality rate; duration of ICU stay; total period of hospitalization; the rate of oxygen use; time to clinical failure; NEWS-2 score on discharge; and the percentage of lung recovery on CT of the chest (the difference value of the CT involvement of lung pathology during admission and at the time of discharge)."
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
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 supplement and retrospective study registry were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The paper did not report a primary outcome. Adverse events are not reported. Random sequence generation method was not adequate. As the registry is retrospective, we were unable to determine if the intervention or outcomes were determined a priori. The study (n=208) did not achieve the target sample size (n=384) calculated in the paper.