Trial NCT04409262
Publication REMDACTA - Rosas IO, Intensive Care Med (2021) (published paper)
Dates: 2020-06-16 to 2021-01-04
Funding: Private (Hoffmann-La Roche)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / USA, Brazil, Russia, Spain
Follow-up duration (days): 60
Inclusion criteria
  • Patients with a positive SARS-CoV-2 polymerase chain reaction test result within 7 days of randomization
  • Pneumonia confirmed by chest x-ray or computed tomography
  • Hypoxemia requiring > 6 L/min supplemental oxygen
  • patients who received ≤ 2 doses of remdesivir before randomization
Exclusion criteria
  • Estimated glomerular filtration rate was < 30 mL/min (including patients undergoing hemodialysis or hemofiltration) or alanine aminotransferase or aspartate aminotransferase levels were > 5 × the upper limit of normal within 24 h of screening
  • Patients with suspected active bacterial, fungal, viral, or other infection except COVID-19
Interventions
Treatment
Tocilizumab+Remdesivir
Tocilizumab: 8 mg/kg (max 800mg) once-off; 1 or 2 doses; Remdesivir: Loading dose: 200 mg IV - Maintenance dose: 100 mg IV once daily from Days 2-10

Control
Remdesivir
Loading dose: 200 mg IV - Maintenance dose: 100 mg IV once daily from Days 2-10

Participants
Randomized
participants :
Remdesivir=215
Tocilizumab+Remdesivir=434
Characteristics of participants
N= 649
Mean age : NR
405 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=553 Critical: n=87
Number of vaccinated participants: NR
Primary outcome
In the register
Time from randomization to hospital discharge or "ready for discharge" up to Day 28 [ Time Frame: Up to Day 28 ]
In the report
Time from randomization to hospital discharge or “ready for discharge,” defined as category 1, assessed by the investigator on the 7-category ordinal scale to day 28.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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 supplemental material, the study registry, protocol and statistical analysis plan were used in data extraction and risk of bias assessment. The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group "Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis." JAMA. 2021;326(6):499–518.) was also used. The authors have been contacted in order to obtain the results.
The primary outcome was modified after the start of the trial. "The primary outcome was initially defined as clinical status assessed by the investigator using a 7-category ordinal scale of clinical status on day 28, but this was changed to time from randomization to hospital discharge or “ready for discharge” to day 28 in response to evolving external data, including results from COVACTA and EMPACTA, which suggested that time to discharge was a more sensitive outcome for trials in this patient population."
This study was updated on November 3rd, 2022 with data extracted from the registry.