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All Studies   Meta Analysis       

Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial

Merchante et al., Antimicrobial Agents and Chemotherapy, doi:10.1128/AAC.02107-21, SARICOR, NCT04357860
Feb 2022  
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Mortality, all patients -35% Improvement Relative Risk Mortality, 400mg 99% Mortality, 200mg -41% Ventilation, all patients -22% Ventilation, 400mg 22% Ventilation, 200mg -68% HFNO, NIMV or IMV, all pat.. 36% primary HFNO, NIMV or IMV, 400mg 59% primary HFNO, NIMV or IMV, 200mg 13% primary Sarilumab  SARICOR  LATE TREATMENT  RCT Is late treatment with sarilumab beneficial for COVID-19? RCT 78 patients in Spain (July 2020 - March 2021) Lower progression with sarilumab (not stat. sig., p=0.23) c19early.org Merchante et al., Antimicrobial Agents.., Feb 2022 Favorssarilumab Favorscontrol 0 0.5 1 1.5 2+
RCT 115 hospitalized COVID-19 pneumonia patients in Spain showing a trend towards reduced progression to severe respiratory failure requiring high-flow oxygen, non-invasive ventilation, or mechanical ventilation, and reduced mortality, with sarilumab 400mg compared to standard of care.
risk of death, 35.2% higher, HR 1.35, p = 0.71, treatment 39, control 39, all patients.
risk of death, 99.0% lower, HR 0.01, p = 0.21, treatment 0 of 39 (0.0%), control 3 of 39 (7.7%), relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), 400mg, Cox proportional hazards, day 28.
risk of death, 41.0% higher, HR 1.41, p = 0.67, treatment 4 of 37 (10.8%), control 3 of 39 (7.7%), 200mg, Cox proportional hazards, day 28.
risk of mechanical ventilation, 22.2% higher, HR 1.22, p = 0.70, treatment 39, control 39, all patients.
risk of mechanical ventilation, 22.0% lower, HR 0.78, p = 0.76, treatment 3 of 39 (7.7%), control 4 of 39 (10.3%), NNT 39, 400mg, Cox proportional hazards, day 28.
risk of mechanical ventilation, 68.0% higher, HR 1.68, p = 0.43, treatment 6 of 37 (16.2%), control 4 of 39 (10.3%), 200mg, Cox proportional hazards, day 28.
HFNO, NIMV or IMV, 36.0% lower, HR 0.64, p = 0.23, treatment 39, control 39, all patients, primary outcome.
HFNO, NIMV or IMV, 59.0% lower, HR 0.41, p = 0.10, treatment 5 of 39 (12.8%), control 11 of 39 (28.2%), NNT 6.5, 400mg, Cox proportional hazards, day 28, primary outcome.
HFNO, NIMV or IMV, 13.0% lower, HR 0.87, p = 0.76, treatment 10 of 37 (27.0%), control 11 of 39 (28.2%), NNT 85, 200mg, Cox proportional hazards, day 28, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Merchante et al., 15 Feb 2022, Randomized Controlled Trial, Spain, peer-reviewed, median age 59.0, 20 authors, study period 13 July, 2020 - 5 March, 2021, trial NCT04357860 (history) (SARICOR). Contact: julian.torre.sspa@juntadeandalucia.es, nicolasmerchante@gmail.com.
This PaperSarilumabAll
Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial
Nicolás Merchante, Sheila Cárcel, José Carlos Garrido-Gracia, Marta Trigo-Rodríguez, María Ángeles, Esteban Moreno, Rafael León-López, Reinaldo Espíndola-Gómez, Eduardo Aguilar Alonso, David Vinuesa García, Alberto Romero-Palacios, Inés Pérez-Camacho, Belén Gutiérrez-Gutiérrez, Francisco Javier Martínez-Marcos, Concepción Fernández-Roldán, Pedro María Martínez Pérez-Crespo, Alexandra Aceituno Caño, Eva León, Juan E Corzo, Carmen De La Fuente, Julián Torre-Cisneros
The objective of this study was to investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalized adults with COVID-19. Methods included phase II, open-label, randomized, controlled clinical trial of hospitalized patients with COVID-19 pneumonia and interleukin (IL)-6 levels $ 40 pg/mL and/or d-dimer . 1,500 ng/mL. Participants were randomized (1:1:1) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (sarilumab-200 group), or SOC plus a single subcutaneous dose of sarilumab 400 mg (sarilumab-400 group). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. One-hundred and 15 participants (control group, n = 39; sarilumab-200, n = 37; sarilumab-400, n = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, 10 (27%) in sarilumab-200, and five (13%) in sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of sarilumab-400 vs control group: 0.41 [0.14, 1.18]; P = 0.09). Seven (6%) patients died: three in the control group and four in sarilumab-200. There were no deaths in sarilumab-400 (P = 0.079, log-rank test for comparisons with the control group). In patients recently hospitalized with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes. (This study has been registered at ClinicalTrials.gov under identifier NCT04357860.)
2 ) 10 ( 9 ) 5 ( 13 ) 1 (3) 2 ( 5 ) 2 ( 5 ) Data are expressed as number (%) of patients. ALT, alanine aminotransferase; AST, aspartate aminotransferase. SUPPLEMENTAL MATERIAL Supplemental material is available online only. SUPPLEMENTAL FILE 1, PDF file, 0.2 MB.
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Late treatment
is less effective
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