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Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial

Mariette et al., The Lancet Rheumatology, doi:10.1016/S2665-9913(21)00315-5, CORIMUNO-SARI-1, NCT04324073
Jan 2022  
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Mortality, day 90 30% Improvement Relative Risk Mortality, day 28 35% Mortality, day 14 32% WHO CPS>5 -1% primary Non-invasive ventilation.. -10% primary Sarilumab  CORIMUNO-SARI-1  LATE TREATMENT  RCT Is late treatment with sarilumab beneficial for COVID-19? RCT 144 patients in France (March - April 2020) Lower mortality with sarilumab (not stat. sig., p=0.4) c19early.org Mariette et al., The Lancet Rheumatology, Jan 2022 Favorssarilumab Favorscontrol 0 0.5 1 1.5 2+
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.
This PaperSarilumabAll
Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial
Prof Xavier Mariette, Olivier Hermine, Pierre-Louis Tharaux, Matthieu Resche-Rigon, Raphael Porcher, Philippe Ravaud, Serge Bureau, Maxime Dougados, Annick Tibi, Elie Azoulay, Jacques Cadranel, Joseph Emmerich, Muriel Fartoukh, Bertrand Guidet, Marc Humbert, Karine Lacombe, Matthieu Mahevas, Frédéric Pene, Valérie Pourchet-Martinez, Frédéric Schlemmer, Yazdan Yazdanpanah, Gabriel Baron, Elodie Perrodeau, Damien Vanhoye, Cécile Kedzia, Lauren Demerville, Anne Gysembergh-Houal, Alexandre Bourgoin, Sarah Dalibey, Nabil Raked, Lakhdar Mameri, Stéphanie Alary, Samir Hamiria, Thinhinane Bariz, Hala Semri, Dhiaa Meriem Hai, Moustafa Benafla, Mohamed Belloul, Pernelle Vauboin, Saskia Flamand, Claire Pacheco, Anouk Walter-Petrich, Emilia Stan, Souad Benarab, Corine Nyanou, Claire Montlahuc, Lucie Biard, Robin Charreteur, Celine Dupré, Kévin Cardet, Blandine Lehmann, Kamyl Baghli, Claire Madelaine, Eric D'ortenzio, Oriane Puéchal, Caroline Semaille, Laurent Savale, Anatole Harrois, Samy Figueiredo, Jacques Duranteau, Nadia Anguel, Arthur Pavot, Xavier Monnet, Christian Richard, Jean-Louis Teboul, Philippe Durand, Pierre Tissieres, Mitja Jevnikar, David Montani, Sophie Bulifon, Xavier Jaïs, Olivier Sitbon, Stéphan Pavy, Nicolas Noel, Olivier Lambotte, Lelia Escaut, Stéphane Jauréguiberry, Elodie Baudry, Christiane Verny, Mathilde Noaillon, Edouard Lefèvre, Mohamad Zaidan, Clotilde Le Tiec Le Tiec, Céline Verstuyft, Anne-Marie Roques, Lamiae Grimaldi, Domitille Molinari, Gaël Leprun, Alain Fourreau, Laurent Cylly, Myriam Virlouvet, Ramdane Meftali, Solène Fabre, Marion Licois, Asmaa Mamoune, Yacine Boudali, Sophie Georgin-Lavialle, Patricia Senet, Gilles Pialoux, Angèle Soria, Antoine Parrot, Hélène François, Nathalie Rozensztajn, Emmanuelle Blin, Pascaline Choinier, Juliette Camuset, Jean-Simon Rech, Antony Canellas, Camille Rolland-Debord, Nadège Lemarié, Nicolas Belaube, Marine Nadal, Martin Siguier, Camille Petit-Hoang, Julie Chas, Elodie Drouet, Matthieu Lemoine, Audrey Phibel, Lucie Aunay, Eliane Bertrand, Sylviane Ravato, Marie Vayssettes, Anne Adda, Celine Wilpotte, Pélagie Thibaut, Julie Fillon, Isabelle Debrix, Soraya Fellahi, Jean-Philippe Bastard, Guillaume Lefèvre, Vincent Fallet, Jacques-Eric Gottenberg, Yves Hansmann, Emmanuel Andres, Sophie Bayer, Guillaume Becker, Frédéric Blanc, Stéphane Brin, Vincent Castelain, Emmanuel Chatelus, Eva Chatron, Olivier Collange, François Danion, Frédéric De Blay, Eric Demonsant, Pierre Diemunsch, Sophie Diemunsch, Renaud Felten, Bernard Goichot, Valentin Greigert, Aurélien Guffroy, Bob Heger, Anne Hutt, Charlotte Kaeuffer, Loic Kassegne, Anne Sophie Korganow, Pierrick Le Borgne, Nicolas Lefebvre, Tristan Martin, Paul Michel Mertes, Catherine Metzger, Nicolas Meyer, Gabriel Nisand, Eric Noll, Mathieu Oberlin, Sophie Ohlmann-Caillard, Vincent Poindron, Julien Pottecher, Yvon Ruch, Cédric Sublon, Hakim Tayebi, François Weill, Arsène Mekinian, Noémie Abisror, Vincent Jachiet, Dorothée Chopin, Olivier Fain, Marc Garnier, Jessica Krause Le Garrec, Marjolaine Morgand, Jerome Pacanowski, Tomas Urbina, Chloe Mcavoy, Maria Pereira, Gladys Aratus, Laurence Berard, Tabassome Simon, Anne Daguenel-Nguyen, Marie Antignac, Céline Leplay, Jean-Benoit Arlet, Jean-Luc Diehl, Florence Bellenfant, Anne Blanchard, Alexandre Buffet, Bernard Cholley, Antoine Fayol, Edouard Flamarion, Anne Godier, Thomas Gorget, Sophie-Rym Hamada, Caroline Hauw-Berlemont, Jean-Sébastien Hulot, David Lebeaux, Marine Livrozet, Adrien Michon, Arthur Neuschwander, Marie-Aude Penet, Benjamin Planquette, Brigitte Ranque, Olivier Sanchez, Geoffroy Volle, Sandrine Briois, Mathias Cornic, Virginie Elisee, Denis Jesuthasan, Juliette Djadi-Prat, Pauline Jouany, Ramon Junquera, Mickael Henriques, Amina Kebir, Isabelle Lehir, Jeanne Meunier, Florence Patin, Valérie Paquet, Anne Tréhan, Véronique Vigna, Brigitte Sabatier, Damien Bergerot, Charléne Jouve, Camille Knosp, Olivia Lenoir, Nassim Mahtal, Léa Resmini, F Lescure, Jade Ghosn, Antoine Bachelard, Timothee Bironne, Raphael Borie, Agathe Bounhiol, Catherine Boussard, Jeanne Chauffier, Solaya Chalal, Lynda Chalal, Malikhone Chansombat, Paul Crespin, Bruno Crestani, Olivia Daconceicao, Laurene Deconinck, Philippe Dieude
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
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