Cardiac Adverse Events and Remdesivir in Hospitalized Patients With COVID-19: A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial
Authors: Terzić Vida , Miantezila Basilua Joe , Billard Nicolas , de Gastines Lucie , Belhadi Drifa , Fougerou-Leurent Claire , Peiffer-Smadja Nathan , Mercier Noémie , Delmas Christelle , Ferrane Assia , Dechanet Aline , Poissy Julien , Espérou Hélène , Ader Florence , Hites Maya , Andrejak Claire , Greil Richard , Paiva José-Artur , Staub Thérèse , Tacconelli Evelina , Burdet Charles , Costagliola Dominique , Mentré France , Yazdanpanah Yazdan , Diallo Alpha ,   DisCoVeRy Study Group, Couffin-Cadièrgues Sandrine , Esperou Hélène , Lamprecht Bernd , Joannidis Michael , Egle Alexander , Greil Richard , Altdorfer Antoine , Fraipont Vincent , Belkhir Leila , Hites Maya , Verschelden Gil , Tolsma Violaine , Bougon David , Delbove Agathe , Gousseff Marie , Saidani Nadia , Wattecamps Guilhem , Djossou Félix , Epelboin Loïc , Lanoix Jean-Philippe , Roger Pierre-Alexandre , Andrejak Claire , Zerbib Yoann , Bouiller Kevin , Chirouze Catherine , Navellou Jean-Christophe , Boyer Alexandre , Cazanave Charles , Duvignaud Alexandre , Gruson Didier , Malvy Denis , Lessire Henry , Martinot Martin , Andreu Pascal , Blot Mathieu , Piroth Lionel , Quenot Jean Pierre , Epaulard Olivier , Terzi Nicolas , Faure Karine , Faure Emmanuel , Poissy Julien , Nseir Saad , Ader Florence , Argaud Laurent , Ferry Tristan , Perpoint Thomas , Piriou Vincent , Richard Jean-Christophe , Textoris Julien , Valour Florent , Wallet Florent , Cabié André , Turmel Jean-Marie , Chabartier Cyrille , Gaci Rostane , Robert Céline , Makinson Alain , Le Moing Vincent , Klouche Kada , Hinschberger Olivier , Mootien Joy , Gibot Sébastien , Goehringer François , Kimmoun Antoine , Lefevre Benjamin , Boutoille David , Canet Emmanuel , Gaborit Benjamin , Le Turnier Paul , Raffi François , Reignier Jean , Courjon Johan , Dellamonica Jean , Leroy Sylvie , Marquette Charles-Hugo , Loubet Paul , Roger Claire , Sotto Albert , Bruel Cédric , Pilmis Benoît , Geri Guillaume , Rouveix-Nordon Elisabeth , Bouchaud Olivier , Figueiredo Samy , Jaureguiberry Stéphane , Monnet Xavier , Bouadma Lila , Lescure François-Xavier , Peiffer-Smadja Nathan , Timsit Jean-François , Yazdanpanah Yazdan , Kerneis Solen , Lachâtre Marie , Launay Odile , Mira Jean-Paul , Mayaux Julien , Pourcher Valérie , Aboab Jérôme , Crockett Flora , Sayre Naomi , Dubost Clément , Ficko Cécile , Lebeaux David , Gallien Sébastien , Mekontso-Dessap Armand , Le Pavec Jérôme , Stefan Francois , Ait-Oufella Hafid , Lacombe Karine , Molina Jean-Michel , Fartoukh Murielle , Pialoux Gilles , Bani-Sadr Firouzé , Mourvillier Bruno , Benezit François , Laine Fabrice , Laviolle Bruno , Le Tulzo Yves , Revest Matthieu , Botelho-Nevers Elisabeth , Gagneux-Brunon Amandine , Thiery Guillaume , Danion François , Hansmann Yves , Meziani Ferhat , Oulehri Walid , Tacquard Charles , Bounes-Vardon Fanny , Martin-Blondel Guillaume , Murris-Espin Marlène , Riu-Poulenc Béatrice , Jeanmichel Vanessa , Senneville Eric , Bernard Louis , Garot Denis , Reuter Jean , Staub Thérèse , Berna Marc , Braz Sandra , Ribeiro Joao Miguel Ferreira , Paiva José-Artur , Roncon-Albuquerque Roberto , Leveau Benjamin 
Published: March 2024

Abstract

Background
We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with coronavirus disease 2019 (COVID-19) who received remdesivir plus standard of care (SoC) compared with SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases.

Methods
This post hoc safety analysis is based on data from the multicenter, randomized, open-label, controlled DisCoVeRy trial in hospitalized patients with COVID-19. Any first AE that occurred between randomization and day 29 in the modified intention-to-treat (mITT) population randomized to either remdesivir or control group was considered. Analysis was performed using Kaplan-Meier survival curves, and Kaplan-Meier estimates were calculated for event rates.

Results
Cardiac AEs were reported in 46 (11.2%) of 410 and 48 (11.3%) of 423 patients in the mITT population (n = 833) enrolled in the remdesivir and control groups, respectively. The difference between both groups was not significant (hazard ratio [HR], 1.0; 95% confidence interval [CI], .7–1.5; P = .98), even when serious and nonserious cardiac AEs were evaluated separately. The majority of reports in both groups were of arrhythmic nature (remdesivir, 84.8%; control, 83.3%) and were associated with a favorable outcome. There was no significant difference between the two groups in the occurrence of cardiac AE subclasses, including arrhythmic events (HR, 1.1; 95% CI, .7–1.7; P = .68).

Conclusions
Remdesivir treatment was not associated with an increased risk of cardiac AEs compared with control in patients hospitalized with moderate or severe COVID-19. These results are consistent with other randomized, controlled trials and meta-analyses.
Clinical Trials Registration. NCT 04315948; EudraCT 2020-000936-23.