Trial NCT04324073
Publication CORIMUNO-SARI-1, Lacent Rheumatol, 2021 (published paper)
Dates: 2020-03-27 to 2020-04-06
Funding: Public/non profit (Ministry of Health, Programme Hospitalier de Recherche Clinique and Assistance Publique – Hôpitaux de Paris Foundation and Foundation for Medical Research.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / France
Follow-up duration (days): 90
Inclusion criteriaHospitalised patients 18 years or older; Confirmed SARS CoV-2 infection (positive on RT-PCR or typical chest CT scan) with mild-to-moderate, severe, or critical pneumonia (receiving > 3L/min of oxygen and having a WHO Clinical Progression Scale [CPS] score > 5; Moderate-to-severe pneumonia with a WHO CPS score of 5, receiving at least 3L/min of oxygen, but without ventilation assistance that included high-flow oxygen, non-invasive ventilation, or mechanical ventilation
Exclusion criteriaICU at admission; Pregnant women
Interventions
Treatment
Sarilumab
400 mg IV infusion once-off; second infusion at day 3 in absence of clinical response
Control
Standard care
Definition of Standard care: Antibiotic agents, antiviral agents, corticosteroids, vasopressor support, anticoagulants.
Participants
Randomized
148 participants (n1=68 / n2= 80)
Characteristics of participants
N=148
Mean age : NR
108 males
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=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
The proportion of patients dead or needing non-invasive ventilation or mechanical ventilation on day 4 (patients with a WHO-CPS score of >5) to be analysed as a binary outcome and survival with no need for non-invasive ventilation (including high-flow oxygen) or mechanical ventilation at day 14, to be analysed as a time-to-event outcome.
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 Data presented was extracted from study registry and 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 authors have been contacted in order to obtain the results.
Data extraction was updated on the 23rd of December, 2021, after the publication of the report. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Some outcomes (adverse and serious adverse events) were not pre-specified in the registry.