Evidence map›Paper›PMID 37953814›Full record

ArticleOpen forum infectious diseases2023

Duvelisib for Critically Ill Patients With Coronavirus Disease 2019: An Investigator-Initiated, Randomized, Placebo-Controlled, Double-Blind Pilot Trial.

Scott R Goldsmith, Fahrettin Covut, Mark Fiala, Zhifu Xiang, Zahid Iqbal, Nathan Moore, Elizabeth Bradtke, Brandon Christen, Michael P Rettig, Stephanie Christ and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04372602 (A Pilot Study of Duvelisib to Combat COVID-19), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT04372602 phase2completednot on this map

A Pilot Study of Duvelisib to Combat COVID-19

TypeinterventionalSponsorWashington University School of MedicineRan2020 to 2022Enrolled28ConditionsCOVID-19ArmsDuvelisib, Peripheral blood draw, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

19 authors at 4 institutions in 1 country.

Scott R GoldsmithDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.ORCID https://orcid.org/0000-0001-9216-2418
Fahrettin CovutDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Mark FialaDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.ORCID https://orcid.org/0000-0002-0208-5023
Zhifu XiangDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Zahid IqbalDivision of Critical Care Medicine, Department of Anesthesiology, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Nathan MooreBarnes Jewish Christian Medical Group, Missouri Baptist Hospital, St Louis, Missouri.
Elizabeth BradtkeDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Brandon ChristenDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Michael P RettigDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Stephanie ChristDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Leah GehrsDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Emily StreetDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Nicholas WallaceDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Julie RitcheyDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Feng GaoDivision of Public Health Sciences, Department of Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Jonathan PachterVerastem Oncology, Needham, Massachusetts, USA.
Bijal ParikhDivision of Laboratory and Genomic Medicine, Department of Pathology and Immunology, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Erik R DubberkeDivision of Infectious Disease, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
John F DiPersioDivision of Oncology, Department of Medicine, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.
Washington University in St. Louis · USBaptist Hospital · USCity Of Hope National Medical Center · USVerastem (United States) · US

Funding

Optimizing Hematopoietic Stem Cell Transplantation For The Treatment Of Hematological MalignanciesR35CA210084 · NCI · WASHINGTON UNIVERSITY · PI John F. Dipersio · 2017 to 2026
$7.8M
BM NICHE DISRUPTION AND IMMUNOTHERAPY IN HEMATOLOGICAL MALIGNANCIESR50CA211466 · NCI · WASHINGTON UNIVERSITY · PI Michael Rettig · 2016 to 2026
$2.3M
NCI NIH HHS R35 CA210084NCI NIH HHS R50 CA211466
6 · The paper itself

Abstract

Background: Despite improvements in prevention and treatment, severe coronavirus disease 2019 (COVID-19) is associated with high mortality. Phosphoinositide 3-kinase (PI3K) pathways contribute to cytokine and cell-mediated lung inflammation. We conducted a randomized, placebo-controlled, double-blind pilot trial to determine the feasibility, safety, and preliminary activity of duvelisib, a PI3Kδγ inhibitor, for the treatment of COVID-19 critical illness. Methods: We enrolled adults aged ≥18 years with a primary diagnosis of COVID-19 with hypoxic respiratory failure, shock, and/or new cardiac disease, without improvement after at least 48 hours of corticosteroid. Participants received duvelisib (25 mg) or placebo for up to 10 days. Participants had daily semi-quantitative viral load measurements performed. Dose modifications were protocol driven due to adverse events (AEs) or logarithmic change in viral load. The primary endpoint was 28-day overall survival (OS). Secondary endpoints included hospital and intensive care unit length of stay, 60-day OS, and duration of critical care interventions. Safety endpoints included viral kinetics and AEs. Exploratory endpoints included serial cytokine measurements and cytometric analysis. Results: Fifteen patients were treated in the duvelisib cohort, and 13 in the placebo cohort. OS at 28 days was 67% (95% confidence interval [CI], 38%-88%) compared to 62% (95% CI, 32%-86%) for placebo ( Conclusions: In this pilot study, duvelisib did not significantly improve 28-day OS compared to placebo for severe COVID-19. Duvelisib appeared safe in this critically ill population and was associated with reduction in cytokines implicated in COVID-19 and acute respiratory distress syndrome, supporting further investigation. Clinical Trials Registration: NCT04372602.

Indexed as

ARDSCOVID-19cytokine stormduvelisibPI3K inhibition

Identifiers

PMID37953814
PMCPMC10633784
OpenAlexW4388193913

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.