Evidence map›Paper›PMID 37074613›Full record

ArticleInfectious diseases and therapy2023

Consistent Effects of Early Remdesivir on Symptoms and Disease Progression Across At-Risk Outpatient Subgroups: Treatment Effect Heterogeneity in PINETREE Study.

Samuel M Brown, Morgan J Katz, Adit A Ginde, Kavita Juneja, Monica Ramchandani, Joshua T Schiffer, Carlos Vaca, Robert L Gottlieb, Yuan Tian, Emon Elboudwarej and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04501952 (A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
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.

NCT04501952 phase3terminatednot on this map

A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting

TypeinterventionalSponsorGilead SciencesRan2020 to 2021Enrolled584ConditionsCOVID-19ArmsRDV, Placebo to Match RDV
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 11 citations in OpenAlex.

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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

18 authors at 8 institutions in 3 countries.

Samuel M BrownIntermountain Healthcare and the University of Utah School of Medicine, Murray, UT, USA.
Morgan J KatzJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Adit A GindeUniversity of Colorado School of Medicine, Aurora, CO, USA.
Kavita JunejaGilead Sciences, Foster City, CA, USA.
Monica RamchandaniGilead Sciences, Foster City, CA, USA.
Joshua T SchifferFred Hutchinson Cancer Center and the University of Washington School of Medicine, Seattle, WA, USA.
Carlos VacaThe Nuren Medical and Research Center, Miami, FL, USA.
Robert L GottliebBaylor University Medical Center and Baylor Scott & White Research Institute, Dallas, TX, USA.
Yuan TianGilead Sciences, Foster City, CA, USA.
Emon ElboudwarejGilead Sciences, Foster City, CA, USA.
Joshua A HillFred Hutchinson Cancer Center and the University of Washington School of Medicine, Seattle, WA, USA.
Richard GilsonUniversity College London Hospitals, London, UK.
Lauren RodriguezGilead Sciences, Foster City, CA, USA.
Charlotte HedskogGilead Sciences, Foster City, CA, USA.
Shuguang ChenGilead Sciences, Foster City, CA, USA.
Jairo M Montezuma-RuscaGilead Sciences, Foster City, CA, USA.
Anu OsinusiGilead Sciences, Foster City, CA, USA.
Roger ParedesDepartment of Infectious Diseases, Hospital Universitari Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Carretera de Canyet, s/n, 08916, Barcelona, Catalonia, Spain. rparedes@irsicaixa.es.
Gilead Sciences (United States) · USFred Hutch Cancer Center · USBaylor Medical Center at Garland · USIntermountain Healthcare · USIrsiCaixa · ESJohns Hopkins Medicine · USRoyal London Hospital · GBUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn the PINETREE study, early remdesivir treatment reduced risk of coronavirus disease 2019 (COVID-19)-related hospitalizations or all-cause death versus placebo by 87% by day 28 in high-risk, non-hospitalized patients. Here we report results of assessment of heterogeneity of treatment effect (HTE) of early outpatient remdesivir, focusing on time from symptom onset and number of baseline risk factors (RFs).

methodsPINETREE was a double-blind, placebo-controlled trial of non-hospitalized patients with COVID-19 who were randomized within 7 days of symptom onset and had ≥ 1 RF for disease progression (age ≥ 60 years, obesity [body mass index ≥ 30], or certain coexisting medical conditions). Patients received remdesivir intravenously (200 mg on day 1 and 100 mg on days 2 and 3) or placebo.

resultsIn this subgroup analysis, HTE of remdesivir by time from symptom onset at treatment initiation and number of baseline RFs was not detected. Treatment with remdesivir reduced COVID-19-related hospitalizations independent of stratification by time from symptom onset to randomization. Of patients enrolled ≤ 5 days from symptom onset, 1/201 (0.5%) receiving remdesivir and 9/194 (4.6%) receiving placebo were hospitalized (hazard ratio [HR] 0.10; 95% confidence interval [CI] 0.01-0.82). Of those enrolled at > 5 days from symptom onset, 1/78 (1.3%) receiving remdesivir and 6/89 (6.7%) receiving placebo were hospitalized (HR 0.19; 95% CI 0.02-1.61). Remdesivir was also effective in reducing COVID-19-related hospitalizations when stratified by number of baseline RFs for severe disease. Of patients with ≤ 2 RFs, 0/159 (0.0%) receiving remdesivir and 4/164 (2.4%) receiving placebo were hospitalized; of those with ≥ 3 RFs, 2/120 (1.7%) receiving remdesivir and 11/119 (9.2%) receiving placebo were hospitalized (HR 0.16; 95% CI 0.04-0.73).

conclusionsIn the outpatient setting, benefit of remdesivir initiated within 7 days of symptoms appeared to be consistent across patients with RFs. Therefore, it may be reasonable to broadly treat patients with remdesivir regardless of comorbidities.

trial registrationClinicalTrials.gov number NCT04501952.

Indexed as

AntiviralCoronavirusCOVID-19OutpatientsRemdesivirSARS-CoV-2

Identifiers

PMID37074613
PMCPMC10113728
OpenAlexW4366352158

What OpenQuestion holds

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LicenceCC BY-NC
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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.