Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial.
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Arabi Yaseen M, Gordon Anthony C, Derde Lennie P G, Nichol Alistair D, Murthy Srinivas, Beidh Farah Al, Annane Djillali, Swaidan Lolowa Al, Beane Abi, Beasley Richard, Berry Lindsay R, Bhimani Zahra, Bonten Marc J M, Bradbury Charlotte A, Brunkhorst Frank M, Buxton Meredith, Buzgau Adrian, Cheng Allen, De Jong Menno, Detry Michelle A, Duffy Eamon J, Estcourt Lise J, Fitzgerald Mark, Fowler Rob, Girard Timothy D, Goligher Ewan C, Goossens Herman, Haniffa Rashan, Higgins Alisa M, Hills Thomas E, Horvat Christopher M, Huang David T, King Andrew J, Lamontagne Francois, Lawler Patrick R, Lewis Roger, Linstrum Kelsey, Litton Edward, Lorenzi Elizabeth, Malakouti Salim, McAuley Daniel F, McGlothlin Anna, Mcguinness Shay, McVerry Bryan J, Montgomery Stephanie K, Morpeth Susan C, Mouncey Paul R, Orr Katrina, Parke Rachael, Parker Jane C, Patanwala Asad E, Rowan Kathryn M, Santos Marlene S, Saunders Christina T, Seymour Christopher W, Shankar-Hari Manu, Tong Steven Y C, Turgeon Alexis F, Turner Anne M, Van de Veerdonk Frank Leo, Zarychanski Ryan, Green Cameron, Berry Scott, Marshall John C, McArthur Colin, Angus Derek C, Webb Steven A, REMAP-CAP Investigators
Аннотация
METHODS: Critically ill adults with COVID-19 were randomized to receive lopinavir-ritonavir, hydroxychloroquine, combination therapy of lopinavir-ritonavir and hydroxychloroquine or no antiviral therapy (control). The primary endpoint was an ordinal scale of organ support-free days. Analyses used a Bayesian cumulative logistic model and expressed treatment effects as an adjusted odds ratio (OR) where an OR > 1 is favorable.
RESULTS: We randomized 694 patients to receive lopinavir-ritonavir (n = 255), hydroxychloroquine (n = 50), combination therapy (n = 27) or control (n = 362). The median organ support-free days among patients in lopinavir-ritonavir, hydroxychloroquine, and combination therapy groups was 4 (- 1 to 15), 0 (- 1 to 9) and-1 (- 1 to 7), respectively, compared to 6 (- 1 to 16) in the control group with in-hospital mortality of 88/249 (35%), 17/49 (35%), 13/26 (50%), respectively, compared to 106/353 (30%) in the control group. The three interventions decreased organ support-free days compared to control (OR [95% credible interval]: 0.73 [0.55, 0.99], 0.57 [0.35, 0.83] 0.41 [0.24, 0.72]), yielding posterior probabilities that reached the threshold futility (≥ 99.0%), and high probabilities of harm (98.0%, 99.9% and > 99.9%, respectively). The three interventions reduced hospital survival compared with control (OR [95% CrI]: 0.65 [0.45, 0.95], 0.56 [0.30, 0.89], and 0.36 [0.17, 0.73]), yielding high probabilities of harm (98.5% and 99.4% and 99.8%, respectively).
CONCLUSION: Among critically ill patients with COVID-19, lopinavir-ritonavir, hydroxychloroquine, or combination therapy worsened outcomes compared to no antiviral therapy.