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Type: | Journal article |
Title: | Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial |
Author: | Arabi, Y.M. Gordon, A.C. Derde, L.P.G. Nichol, A.D. Murthy, S. Beidh, F.A. Annane, D. Swaidan, L.A. Beane, A. Beasley, R. Berry, L.R. Bhimani, Z. Bonten, M.J.M. Bradbury, C.A. Brunkhorst, F.M. Buxton, M. Buzgau, A. Cheng, A. De Jong, M. Detry, M.A. et al. |
Citation: | Intensive Care Medicine, 2021; 47(8):867-886 |
Publisher: | Springer-Verlag |
Issue Date: | 2021 |
ISSN: | 0342-4642 1432-1238 |
Statement of Responsibility: | Yaseen M. Arabi ... et al. on behalf of the REMAP-CAP Investigators: Farah Al-Beidh ... Vishwanath Biradar ... Sandra Peake ... Patricia Williams ... Samuel Gluck ... Stephanie O’Connor ... Marianne Chapman ... et al. |
Abstract: | Purpose: To study the efficacy of lopinavir-ritonavir and hydroxychloroquine in critically ill patients with coronavirus disease 2019 (COVID-19). 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 supportfree 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. |
Keywords: | Adaptive platform trial; Intensive care; Pneumonia; Pandemic; COVID-19; Lopinavir-ritonavir; Hydroxychloroquine |
Rights: | © 2021 Springer-Verlag GmbH Germany, part of Springer Nature |
DOI: | 10.1007/s00134-021-06448-5 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1101719 http://purl.org/au-research/grants/nhmrc/1116530 |
Published version: | http://dx.doi.org/10.1007/s00134-021-06448-5 |
Appears in Collections: | Anaesthesia and Intensive Care publications |
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