Medicina clinica · 2025
Effectiveness and safety of remdesivir and nirmatrelvir-ritonavir in mild to moderate COVID-19 in Spanish hospital emergency departments.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rodríguez-Leal Cristóbal M, González Del Castillo Juan, Ruiz Grinspan Martín Sebastián, Susi García Rosario, Pérez Pérez Teresa, en nombre del grupo de estudio COVID CODE SPAIN
Аннотация
BACKGROUND AND OBJECTIVES: Remdesivir and nirmatrelvir-ritonavir (NTV/r) are the antiviral drugs available in Spain to prevent progression of mild-moderate COVID-19 in vulnerable populations. The pivotal clinical trials of both were conducted under different epidemiological conditions than the current ones. Therefore, their effect in the current setting is uncertain.
PATIENTS AND METHODS: A retrospective, multicentre, observational cohort study was conducted in 16 Spanish hospital emergency departments (ED). Data were collected from all patients with mild to moderate COVID-19 who presented to an ED in the first seven days after symptom onset between 1st January and 31st August 2022. The incidence of hospitalisation or death from any cause at 30 days (composite endpoint) after discharge from the ED was assessed, as was the occurrence of serious adverse drug reactions (ADRs). Data were analysed using Cox multiple regression and standardised survival curves.
RESULTS: A total of 2533 patients were included. The use of NTV/r was associated with a reduced risk of the combined endpoint compared to standard of care (SOC): adjusted hazard ratio (aHR) 0.528, 97.5% confidence interval (97.5%CI): 0.330-0.845; number of patients to treat to avoid an event, 24 (97,5%CI 13-283). No difference was detected between remdesivir and SOC: aHR 0.835: 97,5%CI: 0.524-1.394. No serious ADRs were identified.
CONCLUSION: Early use of NTV/r was associated with less risk of progression of mild to moderate COVID-19 in vulnerable patients, while no differences were found between remdesivir and SOC. Their use was safe.
PATIENTS AND METHODS: A retrospective, multicentre, observational cohort study was conducted in 16 Spanish hospital emergency departments (ED). Data were collected from all patients with mild to moderate COVID-19 who presented to an ED in the first seven days after symptom onset between 1st January and 31st August 2022. The incidence of hospitalisation or death from any cause at 30 days (composite endpoint) after discharge from the ED was assessed, as was the occurrence of serious adverse drug reactions (ADRs). Data were analysed using Cox multiple regression and standardised survival curves.
RESULTS: A total of 2533 patients were included. The use of NTV/r was associated with a reduced risk of the combined endpoint compared to standard of care (SOC): adjusted hazard ratio (aHR) 0.528, 97.5% confidence interval (97.5%CI): 0.330-0.845; number of patients to treat to avoid an event, 24 (97,5%CI 13-283). No difference was detected between remdesivir and SOC: aHR 0.835: 97,5%CI: 0.524-1.394. No serious ADRs were identified.
CONCLUSION: Early use of NTV/r was associated with less risk of progression of mild to moderate COVID-19 in vulnerable patients, while no differences were found between remdesivir and SOC. Their use was safe.
Предметные рубрики MeSH
HumansSpainMaleRetrospective StudiesCOVID-19 Drug TreatmentFemaleAntiviral AgentsRitonavirMiddle AgedAdenosine MonophosphateAlanineAgedEmergency Service, HospitalTreatment OutcomeSeverity of Illness IndexCOVID-19HospitalizationDrug Therapy, CombinationDrug CombinationsPyrazolesTriazinesAdultSARS-CoV-2Adenosine