Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19

Journal of Patient-Reported Outcomes

Research

Anil Gupta¹  Adrienne E. Shapiro²  Dimitra Brintziki³  Helen J. Birch³  Tom J. H. Keeley³  Parima Ghafoori⁴  Amanda Lopuski⁴  John H. Powers⁵  Elias H. Sarkis⁶  Melissa Aldinger⁷  Carolina M. Reyes⁷  Sacha Satram⁷  Elizabeth Alexander⁷ 

[1] Albion Finch Medical, William Osler Health Centre, Toronto, ON, Canada;Departments of Global Health and Medicine, University of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA;GSK, Brentford, Middlesex, UK;GSK, Collegeville, PA, USA;George Washington University School of Medicine, Washington, DC, USA;Sarkis Clinical Trials, Gainesville, FL, USA;Vir Biotechnology, Inc., San Francisco, CA, USA;

关键词: COVID-19;    FLU-PRO Plus;    Monoclonal antibody;    Patient-reported outcomes;    PRO;    Sotrovimab;    Symptoms;   

DOI  :  10.1186/s41687-023-00621-8

 received in 2022-10-17, accepted in 2023-07-26,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe COMET-ICE trial demonstrated that sotrovimab clinically and statistically significantly reduces the risk of all-cause > 24-h hospitalization or death due to any cause among patients with COVID-19 at high risk of disease progression. Patient-reported outcomes are important to capture symptom burden of COVID-19 and assess treatment effectiveness. This study investigated symptoms and their impact over the acute phase of COVID-19 infection among patients on sotrovimab versus placebo.MethodsRandomized (1:1), double-blind, multicenter, placebo-controlled, phase 2/3 study in 57 centers across five countries. Participants were non-hospitalized patients with symptomatic, mild-to-moderate COVID-19 and ≥ 1 baseline risk factor for disease progression (aged ≥ 55 years or ≥ 1 of the following: diabetes requiring medication, obesity, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate-to-severe asthma). An intravenous infusion of sotrovimab 500 mg or placebo was administered on Day 1. The FLU-PRO Plus questionnaire was administered once-daily with 24-h recall from Day 1–21, and at Day 29. Intensity and duration of COVID-19 symptoms were determined from area under the curve (AUC) and mean change in total and individual domain scores through Days 7, 14, and 21. Time to symptom alleviation was assessed.ResultsIn total, 1057 patients were randomized to sotrovimab (n = 528) or placebo (n = 529). At Day 7, mean decrease in FLU-PRO Plus total score (measured by AUC) was statistically significantly greater for patients on sotrovimab (–3.05 [95% confidence interval (CI) –3.27 to –2.83]) than placebo (–1.98 [95% CI –2.20 to –1.76]; difference –1.07 [95% CI –1.38 to –0.76]; p < 0.001). Significant differences were also observed at Days 14 and 21. A more rapid decline in symptom severity was observed with sotrovimab versus placebo through Week 1 and the first 21 days post-treatment. By Day 21, 41% of patients on sotrovimab and 34% on placebo reported symptom resolution. In a post-hoc analysis, median time to symptom alleviation was 4 and 6 days, respectively.ConclusionsSotrovimab provides significant and rapid improvements in patient-reported COVID-19 symptoms, as measured by the FLU-PRO Plus. These results further show the benefits of sotrovimab in alleviating symptoms among high-risk patients with COVID-19.Trial registration ClinicalTrials.Gov: NCT04545060 (https://clinicaltrials.gov/ct2/show/NCT04545060). Date of registration: September 10, 2020 (retrospectively registered).

【 授权许可】

CC BY   
© International Society for Quality of Life Research (ISOQOL) 2023

【 图 表 】

42004_2023_990_Article_IEq37.gif

Fig. 1

Fig. 7

13690_2023_1170_Article_IEq31.gif