Trial NCT04324073
Publication CORIMUNO-SARI-2 - Hermine O, Eur Respir J (2022) (published paper)
Dates: 2020-03-27 to 2020-04-07
Funding: Public/non profit (Assistance Publique - Hôpitaux de Paris)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / France
Follow-up duration (days): 90
Inclusion criteria
  • Confirmed SARS CoV-2 infection (positive on RT-PCR and/or typical chest CT scan) with critical pneumonia (O2>3L/min, WHO Clinical Progression Scale [WHO-CPS] score > 5
  • Patients with non-invasive ventilation (NIV) or mechanical ventilation (MV)
Exclusion criteria
  • Known hypersensitivity to Sarilumab or to any of their excipients
  • Pregnancy
  • Current documented bacterial infection
  • Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, haemoglobin level: no limitation, Platelets (PLT) < 50 G /L, SGOT or SGPT > 5N
Interventions
Treatment
Sarilumab
400 mg IV infusion single dose, second infusion at day 3 in absence of clinical response
Control
Standard care

Participants
Randomized
participants :
Sarilumab=50
Standard care=41
Characteristics of participants
N= 91
Mean age : NR
62 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=25 Critical: n=56
Number of vaccinated participants: 0
Primary outcome
In the register
1. Survival without needs of ventilator utilization at day 14. [ Time Frame: 14 days ] Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR. 2. WHO progression scale <=5 at day 4 [ Time Frame: 4 days ] Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
In the report
1)The early co-primary outcome is the proportion of patients with a decrease of WHO score of at least 1 point at day 4.
2) The longer-term co-primary outcome is the cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation.
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 study registry was used in data extraction and risk of bias assessment. Data was extracted from 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.
The study was updated on March 16th, 2022 with data from the published report.