Trial NCT04376684
Publication 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 806 participants (n1=403 / n2= 403) | |
| Characteristics of participants N=806 Mean age : 59.6 577 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=622 Critical: n=178 | |
| 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 stated 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 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. |