| Title: |
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial |
| Authors: |
Sise, Meghan E; Santos, Jose Ramon; Goldman, Jason D; Tuttle, Katherine R; 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; Ballesteros, Rosa; Malheiro, Luis; Silva, Gil; Correia, João Paulo; Vida, Ana; Silva, Andre; Carujo, Antonio; Garcia, Moncef Belhassen; Fernandez, Jordi Carratala; Abelenda-Alonso, Gabriela; Cruzado, Josep M; Rombauts, Alexander; Sandoval, Diego A; Deltoro, Miguel Garcia; Gimeno, Fransesc Puchades; Gómez-Muñoz, Neus; Roma, Maria Martínez; Gallego, Juan Horcajada; Pablo, Castañeda; Silvia, Padilla Urrea; Sergio, Rial Crestelo; David, Santos Fernandez; Jose, Ramon; Benet, Susanna; Benítez, Rosa; Bracke, Carmen; Chamorro, Anna; España, Sergio; Graterol, Fredzzia; LLadós, Gemma; López, Cristina; Mateu, Lourdes; Paredes, Roger; Rebollo, Boris; Romero, Alba; Soldevila, Laura; Abad, Elena; San José, Alba; Viladomiu, Alex Soriano; McPhail, Mark; Medjeral-Thomas, Nicholas; Lobo, Suzana Margareth Ajeje; Abolnik, Igor; Acharya, Anjali; Allen, Leland; Bellovich, Keith A; Burton, Mary Jane; Cameron, Miriam; Criner, Gerard J; Criner, Lii-Yoong H; Lambert, Joseph; Rashid, Marium; Shore-Brown, Heidi; Diaz, George A; Dougherty, David; Erdmann, Nathaniel B; Fusco, Dahlene; Berrington, William; Logar, Christine; Vadivel, Nidyanandh; Everett, Allison; Lourdes, Gonzalez Suarez Maria; Berhe, Mezgebe; Colbert, Gates; Hebert, Christopher; Mehta, Ankit; Spak, Cedric W; Estrada, Lorie; Vargas, Richard; Choe, Jennifer; Pham, Alex; Mason, L Maria |
| Source: |
Clinical Infectious Diseases, vol 79, iss 5 |
| Publisher Information: |
eScholarship, University of California |
| Publication Year: |
2024 |
| Collection: |
University of California: eScholarship |
| Subject Terms: |
32 Biomedical and Clinical Sciences (for-2020); 3202 Clinical Sciences (for-2020); Coronaviruses Therapeutics and Interventions (rcdc); Coronaviruses (rcdc); Clinical Trials and Supportive Activities (rcdc); Kidney Disease (rcdc); Patient Safety (rcdc); Infectious Diseases (rcdc); Clinical Research (rcdc); Lung (rcdc); Emerging Infectious Diseases (rcdc); 6.1 Pharmaceuticals (hrcs-rac); 3 Good Health and Well Being (sdg); Humans (mesh); Alanine (mesh); Adenosine Monophosphate (mesh); Male (mesh); Female (mesh); Middle Aged (mesh); COVID-19 Drug Treatment (mesh); Antiviral Agents (mesh); Double-Blind Method (mesh); Aged (mesh); SARS-CoV-2 (mesh); COVID-19 (mesh); Hospitalization (mesh); Acute Kidney Injury (mesh); Adult (mesh); Treatment Outcome (mesh); Respiration |
| Time: |
1172 - 1181 |
| Description: |
BACKGROUND: Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-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, chronic kidney disease, 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 from March 2021 to March 2022). The primary efficacy end point was the composite of the all-cause mortality rate or invasive mechanical ventilation rate 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 participants (37.0%) had acute kidney injury (remdesivir, n = 60; placebo, n = 30), 64 (26.3%) had chronic kidney disease (remdesivir, n = 44; placebo, n = 20), and 89 (36.6%) had kidney failure (remdesivir, n = 59; placebo, n = 30); and 31 (12.8%) were vaccinated against COVID-19. Composite all-cause mortality or invasive mechanical ventilation rates through day 29 were 29.4% and 32.5% in the remdesivir and placebo group, respectively (P = .61). Treatment-emergent adverse events were reported in 80.4% for remdesivir versus 77.5% for placebo, and serious adverse events in 50.3% versus 50.0%, respectively. Pharmacokinetic plasma exposure to remdesivir was not affected by kidney function. CONCLUSIONS: Although the study was underpowered, no significant difference in efficacy was observed between treatment groups. REDPINE demonstrated that remdesivir is safe in patients with COVID-19 and severe kidney impairment. CLINICAL TRIALS REGISTRATION: EudraCT 2020-005416-22; Clinical Trials.gov NCT04745351. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
qt0th0g778; https://escholarship.org/uc/item/0th0g778; https://escholarship.org/content/qt0th0g778/qt0th0g778.pdf |
| DOI: |
10.1093/cid/ciae333 |
| Availability: |
https://escholarship.org/uc/item/0th0g778; https://escholarship.org/content/qt0th0g778/qt0th0g778.pdf; https://doi.org/10.1093/cid/ciae333 |
| Rights: |
CC-BY-NC-ND |
| Accession Number: |
edsbas.C54AD012 |
| Database: |
BASE |