Evidence map›Paper›PMID 38913574›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial.

Meghan E Sise, Jose Ramon Santos, Jason D Goldman, Katherine R Tuttle, J Pedro Teixeira, Allan F Seibert, Yiannis Koullias, Joe Llewellyn, Sean Regan, Yang Zhao and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04745351 (A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04745351 phase3terminatednot on this map

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19

TypeinterventionalSponsorGilead SciencesRan2021 to 2022Enrolled249ConditionsCOVID-19ArmsRemdesivir, RDV Placebo, Standard of Care
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Observational
  6. Article
  7. Remdesivir in COVID-19: pros and cons.Frontiers in pharmacology · 2026
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Observational
  14. Article
  15. Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials.Current research in pharmacology and drug discovery · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Meghan E SiseDivision of Nephrology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Jose Ramon SantosFight Infections Foundation, Service of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Jason D GoldmanSwedish Center for Research and Innovation, Providence Swedish Medical Center, Seattle, Washington, USA.
Katherine R TuttleProvidence Medical Research Center, Providence Inland Northwest Health, Spokane, Washington, USA.
J Pedro TeixeiraDivisions of Nephrology and Pulmonary, Critical Care, and Sleep Medicine, University of New Mexico Hospital, Albuquerque, New Mexico, USA.
Allan F SeibertPulmonary Associates Research, Ascension Providence, Mobile, Alabama, USA.
Yiannis KoulliasGilead Sciences, Foster City, California, USA.
Joe LlewellynGilead Sciences, Foster City, California, USA.
Sean ReganGilead Sciences, Foster City, California, USA.
Yang ZhaoGilead Sciences, Foster City, California, USA.
Hailin HuangGilead Sciences, Foster City, California, USA.
Robert H HylandGilead Sciences, Foster City, California, USA.
Anu OsinusiGilead Sciences, Foster City, California, USA.
Helen WinterGilead Sciences, Foster City, California, USA.
Rita HumeniukGilead Sciences, Foster City, California, USA.
Henry N HulterDepartment of Medicine, University of California, San Francisco, California, USA.
Robert L GottliebDepartment of Internal Medicine, Baylor University Medical Center, Dallas, Texas, USA.
Dahlene N FuscoDepartment of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA.
Rita BirneDepartment of Nephrology, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal.
Fernando F StancampianoDepartment of Internal Medicine, Mayo Clinic College of Medicine and Science, Jacksonville, Florida, USA.
Claudia R LibertinDepartment of Internal Medicine, Mayo Clinic College of Medicine and Science, Jacksonville, Florida, USA.
Catherine B SmallDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.
Markus PlateDepartment of Medicine, Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA.
Mark J McPhailInstitute of Liver Studies, King's College Hospital, London, United Kingdom.
REDPINE Investigators

Funding

Gilead Sciences
6 · The paper itself

Abstract

backgroundFew 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.

methodsIn 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.

resultsAlthough 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.

conclusionsAlthough 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.

Indexed as

Adenosine MonophosphateAlanineAntiviral AgentsCOVID-19COVID-19 Drug TreatmentHospitalizationSARS-CoV-2Acute Kidney InjuryAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedAdenosine MonophosphateAlanineAntiviral AgentsremdesivirCOVID-19kidney impairmentremdesivirSARS-CoV-2

Identifiers

PMID38913574
PMCPMC11581693

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.