Pharmacy Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Doctor Esquerdo, 46, 28007, Madrid, Spain.
Infectious Diseases Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Doctor Esquerdo, 46, 28007, Madrid, Spain.
Pharmacol Rep. 2023 Oct;75(5):1254-1264. doi: 10.1007/s43440-023-00519-8. Epub 2023 Sep 1.
Patients with hematological malignancies (HM) are at high risk of COVID-19 progression. Hence, early treatments to prevent progression are needed. The aim of our work was to evaluate the effectiveness and safety of remdesivir (RDV) and SARS-CoV-2 monoclonal antibodies (mAb) in patients with HM and mild-to-moderate disease in real clinical practice.
We conducted a prospective study in a tertiary hospital in 55 HM patients with mild-to-moderate SARS-CoV-2 disease diagnosed between August 2021 and July 2022 and who received RDV or mAb to prevent COVID-19 progression (related death or hospitalization). The primary endpoint was COVID-19 progression on day 28. Other outcomes were COVID-19 progression beyond day 28 and viral load evolution.
RDV was administered to 44 (80.0%) patients and mAb to 11 (20.0%) patients. Death occurred in 1 (1.8%) patient and hospitalization in 9 (16.4%) patients by day 28, respectively; 3 patients (5.5%) required intensive care and 8 (14.5%), oxygen support. Of note, 5 additional patients [15, (27.3%) in total] died or required hospitalization after day 28. Two hazard Cox regression models yielded the absence of anti-SARS-CoV-2 antibodies, age over 65 years, and ECOG-performance status ≥ 2 as the main risk factors for COVID-19-related death or hospitalization.
Our results from clinical practice suggest that RDV and SARS-CoV-2 mAb therapies elicit worse outcomes in hematological patients than those reported for high-risk population in clinical trials.
血液恶性肿瘤（HM）患者罹患 COVID-19 后病情进展的风险较高。因此，需要进行早期治疗以预防疾病进展。我们的研究目的是评估瑞德西韦（RDV）和 SARS-CoV-2 单克隆抗体（mAb）在真实临床实践中治疗 HM 合并轻症至中度疾病患者的疗效和安全性。
我们在一家三级医院开展了一项前瞻性研究，纳入了 55 例 2021 年 8 月至 2022 年 7 月期间诊断为轻症至中度 SARS-CoV-2 疾病且接受 RDV 或 mAb 治疗以预防 COVID-19 进展（相关死亡或住院）的 HM 患者。主要终点为第 28 天 COVID-19 进展情况。次要终点为第 28 天以后 COVID-19 进展情况和病毒载量变化。
44 例（80.0%）患者接受了 RDV 治疗，11 例（20.0%）患者接受了 mAb 治疗。第 28 天，1 例（1.8%）患者死亡，9 例（16.4%）患者住院，3 例（5.5%）患者需要重症监护，8 例（14.5%）患者需要氧疗。值得注意的是，还有 5 例患者[15 例（共计 27.3%）]在第 28 天后死亡或需要住院治疗。2 项风险 Cox 回归模型提示，无抗 SARS-CoV-2 抗体、年龄>65 岁和 ECOG 表现状态≥2 是 COVID-19 相关死亡或住院的主要危险因素。
本临床实践研究结果表明，与临床试验中高危人群相比，RDV 和 SARS-CoV-2 mAb 治疗在血液肿瘤患者中的疗效较差。
