Trial NCT04327388; EudraCT2020-001162-12; U1111-1249-602
Publication Lescure FX, 2021 (quadruple blinding)
Dates: 3/28/2020 to 7/3/2020
Funding: Private (Sanofi and Regeneron Pharmaceuticals, Inc)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: published paper | |
| Location :
Multicenter / Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain Follow-up duration (days): 60 | |
| Inclusion criteria | - Patients aged 18 years or older at the time of signing informed consent;
- Hospitalised for laboratory-confirmed SARS-CoV-2 infection in any specimen within 2 weeks prior to randomisation; - Evidence of pneumonia by chest imaging or chest |
| Exclusion criteria | - Patients with at least one of the following: in the investigatorâs opinion, a low probability of surviving 48 hours or remaining at the investigational site beyond 48 hours;
- Dysfunction of >=2 organ systems or need for extracorporeal life supp |
| Interventions | |
| Treatment 1 Sarilumab 400mg (400 mg) Co-Intervention: Standard care | |
| Control Placebo | |
| Treatment 3 Sarilumab 200mg (200 mg) Co-Intervention: Standard care | |
| Participants | |
| Randomized 420 participants n1=173/ n2=86/ n3=161 | |
| Characteristics of participants N=420 Mean age : NR 261 males Severity : Mild: n=2 / Moderate: n=304/ Severe: n=60 Critical: n=50 | |
| Primary outcome | |
| In the register Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale [ Time Frame: Baseline to Day 29 ] The ordinal scale is an assessment of the clinical status. Score ranges 1-7. Lower score is worse. | |
| In the report Outcomes reported by severity (Severe and critical which correspond to moderate and severe/critical according to our classification) | |
| Documents avalaible |
Protocol NR Statistical plan NR 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 published article, the pre-print article, supplementary materials, and the study registry were used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan were available. There were no substantive differences between the prospective registry and the pre-print article. The study was an adaptive design and any changes in protocol versions are reported with rationales in the article. The study achieved its pre-stated sample size. As this study was conducted in 11 countries across 45 sites, standard of care may have differed (supported by concomitant medication use presented in Table S2).
This study was updated on March 10th with data from the published report. |