Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial
et al., The Lancet Rheumatology, doi:10.1016/S2665-9913(21)00315-5, CORIMUNO-SARI-1, NCT04324073, Jan 2022
RCT 148 hospitalized patients with moderate-to-severe COVID-19 pneumonia in France showing no significant differences with sarilumab treatment.
|
risk of death, 30.0% lower, HR 0.70, p = 0.40, treatment 10 of 68 (14.7%), control 16 of 76 (21.1%), NNT 16, adjusted per study, day 90.
|
|
risk of death, 35.0% lower, HR 0.65, p = 0.35, treatment 8 of 68 (11.8%), control 14 of 76 (18.4%), NNT 15, adjusted per study, day 28.
|
|
risk of death, 32.0% lower, HR 0.68, p = 0.50, treatment 6 of 68 (8.8%), control 8 of 76 (10.5%), adjusted per study, day 14.
|
|
WHO CPS>5, 0.6% higher, RR 1.01, p = 1.00, treatment 18 of 68 (26.5%), control 20 of 76 (26.3%), day 4, primary outcome.
|
|
non-invasive ventilation, mechanical ventilation, or death, 10.0% higher, HR 1.10, p = 0.70, treatment 68, control 76, day 14, primary outcome.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Mariette et al., 31 Jan 2022, Randomized Controlled Trial, France, peer-reviewed, 6 authors, study period 27 March, 2020 - 6 April, 2020, trial NCT04324073 (history) (CORIMUNO-SARI-1).
Contact: xavier.mariette@aphp.fr.
Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial
The Lancet Rheumatology, doi:10.1016/s2665-9913(21)00315-5
Sarilumab in adults hospitalised with
Number at risk Sarilumab
Non-invasive or mechanical ventilation or death
Mechanical ventilation or death
Overall survival
Sarilumab Usual care
Contributors A steering committee was responsible for the design, conduct, and reporting of the trial, and an independent DSMB oversees all CORIMUNO-19 trials (appendix p 1). The manuscript was initially drafted by XM, OH, P-LT, MR-R, RP and PR, and approved by all members of the trial steering committee. MR-R organised collection of the data. RP and PR did the statistical analysis. All authors from the writing committee contributed to design of the trial and of study protocol, data interpretation, and critical review and revision of the manuscript. RP and MR-R had access to the raw data and verified the data and analyses and the fidelity of this report to the study protocol and data analysis plan. All members of the writing committee had full access to all of the data and the final responsibility to submit for publication.
Declaration of interests We declare no competing interests.
Data sharing The protocol, consent form, statistical analysis plan, regulatory documents, and other relevant study materials are available in the appendix (p 22). As described in the protocol, the trial steering committee will facilitate use of the study data and approval will not be unreasonably withheld. Deidentified participant data collected during the CORIMUNO-SARI-1 trial (and the data dictionary) will be made available to bona fide..
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Late treatment
is less effective
is less effective
