• Yonatan Y Greenstein, Kinsley Hubel, Joshua Froess, Stephen R Wisniewski, Vidya Venugopal, Yu-Hsuan Lai, Jeff S Berger, Steven Y Chang, Christos Colovos, Faraaz Shah, Lucy Z Kornblith, Patrick R Lawler, Manila Gaddh, GuerreroRaquel MorilloRMHospital Ramon y Cajal, Madrid, Spain., William Nkemdirim, Renato D Lopes, Harmony R Reynolds, Jose Seijas Amigo, Lana Wahid, Ajani Zahra, Ewan C Goligher, Ryan Zarychanski, Eric Leifer, David T Huang, Matthew D Neal, Judith S Hochman, Mary Cushman, and Michelle N Gong.
• Rutgers New Jersey Medical School, Newark, NJ.
• Chest. 2024 Apr 1; 165 (4): 785799785-799.

BackgroundTherapeutic-dose heparin decreased days requiring organ support in noncritically ill patients hospitalized for COVID-19, but its impact on persistent symptoms or quality of life (QOL) is unclear.Research QuestionIn the Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE (ACTIV-4a) trial, was randomization of patients hospitalized for COVID-19 illness to therapeutic-dose vs prophylactic heparin associated with fewer symptoms and better QOL at 90 days?Study Design And MethodsThis was an open-label randomized controlled trial at 34 hospitals in the United States and Spain. A total of 727 noncritically ill patients hospitalized for COVID-19 from September 2020 to June 2021 were randomized to therapeutic-dose vs prophylactic heparin. Only patients with 90-day data on symptoms and QOL were analyzed. We ascertained symptoms and QOL by the EQ-5D-5L at 90-day follow-up in a preplanned analysis for the ACTIV-4a trial. Individual domains assessed by the EQ-5D-5L included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Univariate and multivariate analyses were performed.ResultsAmong 571 patients, 288 (50.4%) reported at least one symptom. Among 410 patients, 148 (36.1%) reported moderate to severe impairment in one or more domains of the EQ-5D-5L. The presence of 90-day symptoms was associated with moderate-severe impairment in the EQ-5D-5L domains of mobility (adjusted OR [aOR], 2.37; 95% CI, 1.22-4.59), usual activities (aOR, 3.66; 95% CI, 1.75-7.65), pain (aOR, 2.43; 95% CI, 1.43-4.12), and anxiety (aOR, 4.32; 95% CI, 2.06-9.02), compared with patients reporting no symptoms There were no differences in symptoms or in the overall EQ-5D-5L index score between treatment groups. Therapeutic-dose heparin was associated with less moderate-severe impairment in all physical functioning domains (mobility, self-care, usual activities) but was independently significant only in the self-care domain (aOR, 0.32; 95% CI, 0.11-0.96).InterpretationIn a randomized controlled trial of hospitalized noncritically ill patients with COVID-19, therapeutic-dose heparin was associated with less severe impairment in the self-care domain of EQ-5D-5L. However, this type of impairment was uncommon, affecting 23 individuals.Clinical Trial RegistrationClinicalTrials.gov; No.: NCT04505774; URL: www.Clinicaltrialsgov.Copyright © 2023 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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