| Title: |
Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (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; Couffin-Cadièrgues, Sandrine; Esperou, Hélène; Lamprecht, Bernd; Joannidis, Michael; Egle, Alexander; Altdorfer, Antoine; Fraipont, Vincent; Belkhir, Leila; Verschelden, Gil; Tolsma, Violaine; Bougon, David; Delbove, Agathe; Gousseff, Marie; Saidani, Nadia; Wattecamps, Guilhem; Djossou, Félix; Epelboin, Loïc; Lanoix, Jean-Philippe; Roger, Pierre-Alexandre; 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; Nseir, Saad; 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; Timsit, Jean-François; 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; Berna, Marc; Braz, Sandra; Ribeiro, Joao Miguel Ferreira; Roncon-Albuquerque, Roberto; Leveau, Benjamin |
| Contributors: |
Clinical Trial Safety and Public Health; Ecosystème intestinal, probiotiques, antibiotiques (EA 4065); Université Paris Descartes - Paris 5 (UPD5); Clinical Investigation Center CIC-EC 1425, Inserm, Paris; Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord; Département d'épidémiologie, biostatistique et recherche clinique; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre Hospitalier Universitaire Rennes; Centre d'Investigation Clinique Rennes (CIC); Université de Rennes (UR)-Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou -Institut National de la Santé et de la Recherche Médicale (INSERM); Services de Maladies Infectieuses et Tropicales CHU Bichat; AP-HP - Hôpital Bichat - Claude Bernard Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS); Institut de Santé Publique; University of Medicine and Pharmacy “Carol Davila” (UMPCD); Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF); Université de Lille-Centre National de la Recherche Scientifique (CNRS); Centre International de Recherche en Infectiologie (CIRI); École normale supérieure de Lyon (ENS de Lyon); Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Université libre de Bruxelles = Free University of Brussels (ULB); Agents infectieux, résistance et chimiothérapie - UR UPJV 4294 (AGIR); Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie; CHU Amiens-Picardie; Discovery French Trial Management Team; Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU); Universidade do Porto = University of Porto; Centre Hospitalier de Luxembourg Luxembourg (CHL); Università degli studi di Verona = University of Verona (UNIVR); UFR de Médecine - Université de Picardie Jules Verne (UPJV Médecine); Université de Picardie Jules Verne (UPJV); Médecine Intensive-Réanimation CHU Amiens |
| Source: |
ISSN: 1058-4838. |
| Publisher Information: |
CCSD; Oxford University Press (OUP) |
| Publication Year: |
2024 |
| Collection: |
Université Jean Monnet – Saint-Etienne: HAL |
| Subject Terms: |
COVID-19; antiviral therapy; cardiac adverse events; randomized controlled trials; remdesivir; [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Description: |
International audience ; Background We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with Coronavirus Disease 2019 (COVID-19) receiving remdesivir plus standard of care (SoC) compared to 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 (NCT04315948). Any first AE occurring 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 (HR 1.0, 95% CI 0.7-1.5, p = 0.98), even when evaluating serious and non-serious cardiac AEs 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 remdesivir and control groups in the occurrence of different cardiac AE subclasses, including arrhythmic events (HR 1.1, 95% CI: 0.7-1.7, p = 0.68). Conclusions Remdesivir treatment was not associated with an increased risk of cardiac AEs, whether serious or not, and regardless of AE severity, compared to control, in patients hospitalized with moderate or severe COVID-19. This is consistent with the results of other randomized controlled trials and meta-analyses. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/38552208; PUBMED: 38552208 |
| DOI: |
10.1093/cid/ciae170 |
| Availability: |
https://u-picardie.hal.science/hal-04529469; https://u-picardie.hal.science/hal-04529469v2/document; https://u-picardie.hal.science/hal-04529469v2/file/ciae170.pdf; https://doi.org/10.1093/cid/ciae170 |
| Rights: |
https://creativecommons.org/licenses/by-nc-nd/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.DB2678DB |
| Database: |
BASE |