Covid-19 Living Data

Trial NCT04324073
Publication CORIMUNO-SARI-1 - Mariette X, Lancet 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 criteria	Hospitalised 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 criteria	ICU at admission Pregnant women
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=68 Standard care=80
	Characteristics of participants N= 148 Mean age : NR 108 males Severity : Mild: n=0 / Moderate: n=144 / Severe: n=0 Critical: n=0 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 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 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	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. For time to mechanical ventilation or death, the bayesian adjusted analysis was utilized; adjusted on age and center. The study was updated on August 4th, 2022 with data extracted after contact with authors.