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- Title
Association Between Concomitant Hydroxychloroquine Use and Safety and Efficacy of Remdesivir in Severe COVID-19 Patients.
- Authors
Jeong-a Lee; George Diaz; Cattelan, Anna Maria; Balani, Bindu; Arribas, Jose Ramon; Tashima, Karen T.; Gottlieb, Robert L.; Sanyal, Arun J.; Elboudwarej, Emon; Yuan Tian; Tan, Susanna K.; Huyen Cao; Anuj Gaggar; Chokkalingam, Anand P.; Osinusi, Anu O.; Brainard, Diana M.; Goldman, Jason D.
- Abstract
배경 Remdesivir (RDV) has demonstrated potent in vitro and in vivo activity against SARS-CoV-2 and favorable clinical efficacy and tolerability in patients with COVID-19. Hydroxychloroquine (HQN) is an experimental treatment for COVID-19. Effects of coadministration of HQN with RDV have not been studied and are relevant given the long half-life (~22 days) of HQN. Here we report the impact of concomitant HQN and RDV use on clinical outcomes and safety. 방법 We conducted a randomized, open-label, phase 3 trial, involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of ≤94% on room air, and radiological evidence of pneumonia. Patients were randomized 1:1 to receive either 5d or 10d of intravenous RDV once-daily. We compared patients who ever received concomitant HQN (HQN+) with those who did not (HQN-). Clinical recovery and all-cause mortality were evaluated using Cox proportional hazards. Potential covariates for adjustment included baseline demographics (age, sex, race, region), disease characteristics (symptom duration, oxygen support status), and comorbidities (cardiovascular disease, diabetes, obesity); included covariates were significant at p<0.05. Recovery and adverse events (AEs) were assessed through 28d. 결과 Of 397 patients treated with RDV, 160 (40%) received HQN. Compared to HQN-, fewer HQN+ patients were obese (34% vs 47%) or had cardiovascular disease (19% vs 31%), and more were male (71% vs 59%), on forced ventilation or high-flow oxygen support at baseline (46% vs 21%), and White (84% vs 59%) (all p<0.05). Through median follow-up of 10d (range 1-33d), proportion and risk of recovery were lower in HQN+ vs. HQN- patients (65% vs 76%; covariate-adjusted HR [95% CI] 0.68 [0.51, 0.91], p=0.009). More HQN+ patients experienced AEs; after adjustment for baseline covariates, this difference was significant for grade 3-4 AEs (Table). 결론 In severe COVID-19 patients who received RDV, concomitant HQN use was associated with lower rates of improvement and higher rates of AEs.
- Subjects
COVID-19; HYDROXYCHLOROQUINE; REMDESIVIR; SARS-CoV-2; SYMPTOMS; CARDIOVASCULAR diseases
- Publication
Infection & Chemotherapy, 2020, Vol 52, pS380
- ISSN
2093-2340
- Publication type
Article