Case report study of the first five COVID-19 patients treated with remdesivir in France
et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.06.093, Jun 2020
Early report on 5 ICU patients treated with remdesivir highlighting issues with usage in critically ill patients.
Gérard, Zhou, Wu, Kamo, Choi, Kim show increased risk of acute kidney injury, Leo, Briciu, Muntean, Petrov show increased risk of liver injury, and Negru, Cheng, Mohammed show increased risk of cardiac disorders with remdesivir.
1.
Gérard et al., Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database, Clinical Pharmacology & Therapeutics, doi:10.1002/cpt.2145.
2.
Zhou et al., Acute Kidney Injury and Drugs Prescribed for COVID-19 in Diabetes Patients: A Real-World Disproportionality Analysis, Frontiers in Pharmacology, doi:10.3389/fphar.2022.833679.
3.
Wu et al., Acute Kidney Injury Associated With Remdesivir: A Comprehensive Pharmacovigilance Analysis of COVID-19 Reports in FAERS, Frontiers in Pharmacology, doi:10.3389/fphar.2022.692828.
4.
Kamo et al., Association of Antiviral Drugs for the Treatment of COVID-19 With Acute Renal Failure, In Vivo, doi:10.21873/invivo.13637.
5.
Choi et al., Comparative effectiveness of combination therapy with nirmatrelvir–ritonavir and remdesivir versus monotherapy with remdesivir or nirmatrelvir–ritonavir in patients hospitalised with COVID-19: a target trial emulation study, The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00353-0.
6.
Kim et al., Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study, Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043.
7.
Leo et al., Hepatocellular liver injury in hospitalized patients affected by COVID-19: Presence of different risk factors at different time points, Digestive and Liver Disease, doi:10.1016/j.dld.2021.12.014.
8.
Briciu et al., Evolving Clinical Manifestations and Outcomes in COVID-19 Patients: A Comparative Analysis of SARS-CoV-2 Variant Waves in a Romanian Hospital Setting, Pathogens, doi:10.3390/pathogens12121453.
9.
Muntean et al., Effects of COVID-19 on the Liver and Mortality in Patients with SARS-CoV-2 Pneumonia Caused by Delta and Non-Delta Variants: An Analysis in a Single Centre, Pharmaceuticals, doi:10.3390/ph17010003.
10.
Petrov et al., The Effect of Potentially Hepatotoxic Medicinal Products on Alanine Transaminase Levels in COVID-19 Patients: A Case–Control Study, Safety and Risk of Pharmacotherapy, doi:10.30895/2312-7821-2025-458.
11.
Negru et al., Comparative Pharmacovigilance Analysis of Approved and Repurposed Antivirals for COVID-19: Insights from EudraVigilance Data, Biomedicines, doi:10.3390/biomedicines13061387.
Dubert et al., 30 Jun 2020, peer-reviewed, 15 authors.
Case report study of the first five COVID-19 patients treated with remdesivir in France
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2020.06.093
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been identified as the virus responsible for the coronavirus disease 2019 (COVID-19) outbreak worldwide. Data on treatment are scare and parallels have been made between SARS-CoV-2 and other coronaviruses. Remdesivir is a broad-spectrum antiviral with efficient in vitro activity against SARS-CoV-2. Evidence of clinical improvement in patients with severe COVID-19 treated with remdesivir is controversial. The aim of this study was to describe the clinical outcomes and virological monitoring of the first five COVID-19 patients admitted to the intensive care unit of Bichat-
Author contributions All authors have read and approved the manuscript. MD, VI, YY, JG, and XL wrote the manuscript and took care of the patients in the infectious and tropical diseases department. LD, DLP, and CR took care of the patients in the infectious and tropical diseases department. BV participated to the virological tests and wrote the manuscript. QLH and NHF participated in the virological tests. LB, JP, and PHW took care of the patients in the medical and infectious intensive care unit. LK assisted in obtaining and dispensing the drug.
Consent for publication The Institutional Review Board of Bichat-Claude Bernard University Hospital approved this report and waived the need for informed consent from individual patients, due to the retrospective chart review design and absence of identifying images or personal/clinical details that could compromise anonymity.
Conflict of interest The authors declare that they have no competing interests.
References
Arabi, Asiri, Assiri, Jokhdar, Alothman et al., Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial, Trials
Chen, Hu, Zhang, Jiang, Han et al., Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial, medRxiv
Chu, Cheng, Hung, Wong, Chan et al., Role of lopinavir/ritonavir in the treatment of SARS: initial virological and clinical findings, Thorax
Corman, Bleicker, Brunink, Drosten, Diagnostic detection of 2019-nCoV by real-time RT-PCR -protocol and preliminary evaluation as of Jan 17
Gautret, Lagier, Parola, Hoang, Meddeb et al., Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial, Int J Antimicrob Agents
Grein, Ohmagari, Shin, Diaz, Asperges et al., Compassionate use of remdesivir for patients with severe Covid-19, N Engl J Med
Holshue, Debolt, Lindquist, Lofy, Wiesman et al., First case of 2019 novel coronavirus in the United States, N Engl J Med
Kujawski, Wong, Collins, Epstein, Killerby et al., First 12 patients with coronavirus disease 2019 (COVID-19) in the United States
Lescure, Bouadma, Nguyen, Parisey, Wicky et al., Clinical and virological data of the first cases of COVID-19 in Europe: a case series, Lancet Infect Dis
Martinez, Compounds with therapeutic potential against novel respiratory 2019 coronavirus, Antimicrob Agents Chemother
Mulangu, Dodd, Davey, Mbaya, Proschan et al., A randomized, controlled trial of ebola virus disease therapeutics, N Engl J Med
Savarino, Trani, Donatelli, Cauda, Cassone, New insights into the antiviral effects of chloroquine, Lancet Infect Dis
Sheahan, Sims, Graham, Menachery, Gralinski et al., Broadspectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses, Sci Transl Med
Wang, Cao, Zhang, Yang, Liu et al., Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Res 2020a
Wang, Zhang, Du, Du, Zhao et al., Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial, Lancet
Zhu, Zhang, Li, Yang, Song, A novel coronavirus from patients with pneumonia in China, 2019, N Engl J Med
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Late treatment
is less effective
is less effective
