Trial NCT04376684
Publication OSCAR - Patel J, medRxiv (2021) (preprint)
Dates: 2020-05-28 to 2020-11-15
Funding: Private (GSK)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / Argentina, Belgium, Brazil, Canada, Chile, France, India, Japan, Mexico, Netherlands, Peru, Poland, Russia, South Africa, Spain, UK, USA
Follow-up duration (days): 60
Inclusion criteria
  • Hospitalized adult patients (≥18 to ≤79 years of age)
  • confirmed SARS-CoV-2 pneumonia
  • new onset hypoxemia requiring any of high-flow oxygen (≥15 L/min), non-invasive ventilation or mechanical ventilation (MV
  • duration ≤48 hours prior to dose)
  • increased biological markers of systemic inflammation (C-reactive protein or serum ferritin above local upper limit of normal)
Exclusion criteria
  • Death considered likely within 48 hours
  • multiple organ failure according to the investigator’s opinion or a Sequential Organ Failure Assessment (SOFA) score >10 if in the ICU
  • or use of extracorporeal membrane oxygenation, hemofiltration/dialysis, high-dose (>0.15 μg/kg/min) noradrenaline (or equivalent) or >1 vasopressor.
Interventions
Treatment
Otilimab
90 mg single (1 hour) intravenous infusion

Control
Placebo

Participants
Randomized
participants :
Otilimab=403
Placebo=403
Characteristics of participants
N= 806
Mean age : NR
577 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=622 Critical: n=178
Number of vaccinated participants: NR
Primary outcome
In the register
Proportion of participants alive and free of respiratory failure at Day 28 (measured by an 8-point ordinal scale).
In the report
The proportion of patients alive and free of respiratory failure (clinical status Categories 1, 2, 3, or 4) at Day 28
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:
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 pre-print article, the trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. There were no substantive differences between the article and the trial registry, protocol and statistical analysis plan in population, procedures, intervention and outcomes. The primary outcome indicated in the registry reflects the primary outcome reported in the paper. The report is for part 1 of a 2-part study. The target sample size in the trial registry appears to be for both parts 1 and 2. Part 1 achieved the sample size specified in the protocol and methods section.
This study was updated on the 28th of September 2022 with data extracted from the registry.