Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial.
Publication Title
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Document Type
Article
Publication Date
6-24-2024
Keywords
washington; swedish; covid-19
Abstract
BACKGROUND: Few antiviral therapies have been studied in patients with COVID-19 and kidney impairment. Herein, efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-beta-cyclodextrin excipient were evaluated in hospitalized patients with COVID-19 and severe kidney impairment.
METHODS: In REDPINE, a phase 3, randomized, double-blind, placebo-controlled study, participants aged ≥12 years hospitalized for COVID-19 pneumonia with acute kidney injury (AKI), chronic kidney disease (CKD), or kidney failure were randomized 2:1 to receive intravenous remdesivir (200 mg on Day 1; 100 mg daily up to Day 5) or placebo (enrollment: March 2021-March 2022). The primary efficacy endpoint was the composite of all-cause mortality or invasive mechanical ventilation (IMV) through Day 29. Safety was evaluated through Day 60.
RESULTS: Although enrollment concluded early, 243 participants were enrolled and treated (remdesivir, n = 163; placebo, n = 80). At baseline, 90 (37.0%) participants had AKI (remdesivir, 60; placebo, 30), 64 (26.3%) had CKD (remdesivir, 44; placebo, 20), and 89 (36.6%) had kidney failure (remdesivir, 59; placebo, 30); 31 (12.8%) were COVID-19 vaccinated. Composite all-cause mortality or IMV through Day 29 was 29.4% and 32.5% in the remdesivir and placebo group, respectively (P = 0.61). Treatment-emergent adverse events were reported in 80.4% versus 77.5% and serious adverse events in 50.3% versus 50.0% of participants who received remdesivir versus placebo, respectively. Pharmacokinetic plasma exposure to remdesivir was not affected by kidney function.
CONCLUSIONS: Although underpowered, no significant difference in efficacy was observed between treatment groups. REDPINE demonstrated that remdesivir is safe in those with COVID-19 and severe kidney impairment. (EudraCT number: 2020-005416-22; Clinical Trials.gov number: NCT04745351).
TRIAL REGISTRATION: EudraCT number: 2020-005416-22; Clinical Trials.gov number: NCT04745351.
Clinical Institute
Cancer
Clinical Institute
Kidney & Diabetes
Specialty
Nephrology
Specialty
Infectious Diseases
Specialty
Pharmacy
Recommended Citation
Sise, Meghan E; Santos, Jose Ramon; Goldman, Jason D; Tuttle, Katherine; Teixeira, J Pedro; Seibert, Allan F; Koullias, Yiannis; Llewellyn, Joe; Regan, Sean; Zhao, Yang; Huang, Hailin; Hyland, Robert H; Osinusi, Anu; Winter, Helen; Humeniuk, Rita; Hulter, Henry N; Gottlieb, Robert L; Fusco, Dahlene N; Birne, Rita; Stancampiano, Fernando F; Libertin, Claudia R; Small, Catherine B; Plate, Markus; McPhail, Mark J; REDPINE Investigators; and Tuttle, Katherine, "Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial." (2024). Articles, Abstracts, and Reports. 8921.
https://digitalcommons.providence.org/publications/8921
