Evidence map›Paper›PMID 40461100›Full record

Trial reportImmunoHorizons2025

Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization.

Phillip Scheinberg, Matt R Khoshnevis, Philip A Robinson, Alfredo Guerreros, Victor A H Sato, Benedito A L Fonseca, Hans W Prozesky, José Omar Chacón Romero, Laura Fogliatto, Barry R Meisenberg and 6 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ImmunoHorizons, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT04346199 phase2completednot on this map

A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19

TypeinterventionalSponsorAstraZenecaRan2020 to 2020Enrolled177ConditionsCOVID-19ArmsAcalabrutinib
NCT04380688 phase2completednot on this map

A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19

TypeinterventionalSponsorAstraZenecaRan2020 to 2020Enrolled62ConditionsCOVID-19ArmsAcalabrutinib
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Phillip ScheinbergDivision of Hematology, Hospital A Beneficência Portuguesa, São Paulo, Brazil.
Matt R KhoshnevisCenter for Critical Care, Houston Methodist Hospital, Houston, TX, United States.
Philip A RobinsonInfection Prevention and Hospital Epidemiology, Hoag Memorial Hospital Presbyterian, Newport Beach, CA, United States.
Alfredo GuerrerosDepartment of Medicine, Clinica Internacional, Lima, Peru.ORCID 0000-0002-3240-2886
Victor A H SatoInternational Research Center, Hospital Alemao Oswaldo Cruz, São Paulo, Brazil.
Benedito A L FonsecaHospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRP), São Paulo, Brazil.ORCID 0000-0003-3159-5687
Hans W ProzeskyDivision of Infectious Diseases, Department of Medicine, Stellenbosch University and TREAD Research, Tygerberg Hospital, Cape Town, South Africa.ORCID 0000-0001-9715-3449
José Omar Chacón RomeroHospital Sub-direction, IMSS HGR No. 1 Dr Carlos Mac Gregor Sanchez Navarro, Mexico City, Mexico.
Laura FogliattoHematology and Hemotherapy Department, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.
Barry R MeisenbergDepartment of Medicine, Anne Arundel Medical Center, Annapolis, MD, United States.ORCID 0000-0002-3580-4805
David J ParkHematology and Oncology, Providence St Jude Medical Center/Providence Medical Foundation, Fullerton, CA, United States.
Ashok GuptaOncology Research and Development, AstraZeneca, Gaithersburg, MD, United States.
Priti PatelHaematology Research and Development, AstraZeneca, South San Francisco, CA, United States.
Danielle M TownsleyOncology Research and Development, AstraZeneca, Gaithersburg, MD, United States.
Lianqing ZhengOncology Biometrics, AstraZeneca, South San Francisco, CA, United States.
Veerendra MunugalavadlaHaematology Research and Development, AstraZeneca, South San Francisco, CA, United States.ORCID 0000-0002-2390-3822

Funding

AstraZeneca, Gaithersburg, MD, USA
6 · The paper itself

Abstract

The efficacy and safety of acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, was evaluated in 2 phase 2 studies in hospitalized patients with coronavirus disease 2019 (COVID-19) who received acalabrutinib + best supportive care (BSC) versus BSC alone (Clinicaltrials.gov: NCT04380688 and NCT04346199). The primary endpoint was the percentage of patients alive and free of respiratory failure on day 14 (rest of the world [RoW] study) and day 28 (US study). In the RoW study, 177 patients were randomized (acalabrutinib + BSC: n = 89; BSC: n = 88); in the US study, 62 patients were randomized (acalabrutinib + BSC: n = 31; BSC: n = 31). The percentage of patients who met the primary endpoint was similar in both studies (RoW study: acalabrutinib + BSC: 83.1%, BSC: 90.9%; US study: acalabrutinib + BSC: 80.6%, BSC: 83.9%). No new safety concerns were reported. Overall, no significant clinical benefit of adding acalabrutinib to BSC in patients hospitalized with COVID-19 was observed.

Indexed as

BenzamidesCOVID-19 Drug TreatmentProtein Kinase InhibitorsPyrazinesAdultAgammaglobulinaemia Tyrosine KinaseAgedAged, 80 and overCOVID-19FemaleHospitalizationHumansMaleMiddle AgedSARS-CoV-2Treatment OutcomeacalabrutinibAgammaglobulinaemia Tyrosine KinaseBenzamidesProtein Kinase InhibitorsPyrazinesacalabrutinibbest supportive carebruton tyrosine kinase inhibitorCOVID-19hospitalized patients

Identifiers

PMID40461100
PMCPMC12133263

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.