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version: 15; Last updated: 2025-10-13 16:59:33+0000

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/PublicationRecord/5192

identifier: FEvIR Object Identifier/5192

title: Anticoagulation for COVID-19 Combined RCTs PrePrint

status: Active

date: 2021-09-22 19:03:30+0000

author: Brian S. Alper:

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

description:

A preprint for combination of 3 adaptive RCTs

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Computable Publishing

Therapeutic Anticoagulation in Non-Critically Ill Patients with Covid-19 [Preprint], version v1. Contributors: The ATTACC, ACTIV-4a, and REMAP-CAP Investigators, Patrick R. Lawler, Ewan C. Goligher, Jeffrey S. Berger, Matthew D. Neal, Bryan J. McVerry, Jose C. Nicolau, Michelle N. Gong, Marc Carrier, Robert S. Rosenson, Harmony R. Reynolds, Alexis F. Turgeon, Jorge Escobedo, David T. Huang, Charlotte Ann Bradbury, Brett L. Houston, Lucy Z. Kornblith, Anand Kumar, Susan R. Kahn, Mary Cushman, Zoe McQuilten, Arthur S. Slutsky, Keri S. Kim, Anthony C. Gordon, Bridget-Anne Kirwan, Maria M. Brooks, Alisa M. Higgins, Roger J. Lewis, Elizabeth Lorenzi, Scott M. Berry, Lindsay R. Berry, Derek C. Angus, Colin J. McArthur, Steven A. Webb, Michael E. Farkouh, Judith S. Hochman, Ryan Zarychanski. In: medRxiv, DOI 10.1101/2021.05.13.21256846. Published May 17, 2021. Accessed July 16, 2021. Available at: https://doi.org/10.1101/2021.05.13.21256846.

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identifier: https://doi.org/10.1101/2021.05.13.21256846
relatedIdentifier: ClinicalTrials.gov/NCT02735707, ClinicalTrials.gov/NCT04505774, ClinicalTrials.gov/NCT04359277, ClinicalTrials.gov/NCT04372589
dateAccessed: 2021-07-16
version: v1
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* Posted true 2021-05-17 --> (ongoing)
title
type: Primary title
language: English
text:
Therapeutic Anticoagulation in Non-Critically Ill Patients with Covid-19

title
type: Title used in Supplement
language: English
text:
Multi-Platform Randomized Controlled Trial (mpRCT) Therapeutic anticoagulation in patients with moderate Covid-19

Abstracts
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* Primary human use English
Background Thrombo-inflammation may contribute to morbidity and mortality in Covid-19. We hypothesized that therapeutic-dose anticoagulation may improve outcomes in non-critically ill patients hospitalized for Covid-19.

Methods In an open-label adaptive multiplatform randomized controlled trial, non-critically ill patients hospitalized for Covid-19, defined by the absence of critical care-level organ support at enrollment, were randomized to a pragmatic strategy of therapeutic-dose anticoagulation with heparin or usual care pharmacological thromboprophylaxis. The primary outcome combined survival to hospital discharge and days free of organ support through 21 days, which was evaluated with Bayesian statistical models according to baseline D-dimer.

Results The trial was stopped when prespecified criteria for superiority were met for therapeutic-dose anticoagulation in groups defined by high (≥2-fold elevated) and low (<2-fold elevated) D-dimer. Among 2219 participants in the final analysis, the probability that therapeutic anticoagulation increased organ support-free days compared to thromboprophylaxis was 99.0% (adjusted odds ratio 1.29, 95% credible interval 1.04 to 1.61). The adjusted absolute increase in survival to hospital discharge without organ support with therapeutic-dose anticoagulation was 4.6% (95% credible interval 0.7 to 8.1). In the primary adaptive stopping groups, the final probabilities of superiority for therapeutic anticoagulation were 97.3% in the high D-dimer group and 92.9% in the low D-dimer group. Major bleeding occurred in 1.9% and 0.9% of participants randomized to therapeutic anticoagulation and thromboprophylaxis, respectively.

Conclusions In non-critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increases the probability of survival to hospital discharge with reduced use of organ support.

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* Replaced With Journal Article Anticoagulation for COVID-19 Combined RCTs in NEJM PublicationRecord Anticoagulation for COVID-19 Combined RCTs in NEJM
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articleDate: 2021-05-17
language: English
pageCount: 32 pages
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url: https://doi.org/10.1101/2021.05.13.21256846
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url: https://www.medrxiv.org/content/10.1101/2021.05.13.21256846v1.full-text
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The ATTACC, ACTIV-4a, and REMAP-CAP Investigators, Patrick R. Lawler, Ewan C. Goligher, Jeffrey S. Berger, Matthew D. Neal, Bryan J. McVerry, Jose C. Nicolau, Michelle N. Gong, Marc Carrier, Robert S. Rosenson, Harmony R. Reynolds, Alexis F. Turgeon, Jorge Escobedo, David T. Huang, Charlotte Ann Bradbury, Brett L. Houston, Lucy Z. Kornblith, Anand Kumar, Susan R. Kahn, Mary Cushman, Zoe McQuilten, Arthur S. Slutsky, Keri S. Kim, Anthony C. Gordon, Bridget-Anne Kirwan, Maria M. Brooks, Alisa M. Higgins, Roger J. Lewis, Elizabeth Lorenzi, Scott M. Berry, Lindsay R. Berry, Derek C. Angus, Colin J. McArthur, Steven A. Webb, Michael E. Farkouh, Judith S. Hochman, Ryan Zarychanski

summary
type: Funding Statement
source: Copied from article
value:
REMAP-CAP: Supported by the European Union through FP7-HEALTH-2013-INNOVATION: the Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium (602525), and Horizon 2020 research and innovation program: the Rapid European Covid-19 Emergency Research response (RECOVER) consortium (101003589) and by the Australian National Health and Medical Research Council (APP1101719), the Health Research Council of New Zealand (16/631), a Canadian Institutes of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant (158584), the U.K. NIHR and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Breast Cancer Research Foundation, the French Ministry of Health (PHRC-20-0147), the Minderoo Foundation, Amgen, Eisai, the Global Coalition for Adaptive Research, and the Wellcome Trust Innovations Project (215522). Dr. Gordon is funded by an NIHR Research Professorship (RP-2015-06-18), and Dr. Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011). The ATTACC platform was supported by grants from the Canadian Institutes of Health Research, LifeArc Foundation, Thistledown Foundation, Research Manitoba, Ontario Ministry of Health, and the Peter Munk Cardiac Centre. The ACTIV-4a platform was sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD and administered through OTA-20-011. Disclaimer: The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service (UK), the National Institute for Health Research (UK), the Department of Health and Social Care (UK), or of the National Institutes of Health (USA).