Safety, tolerability and clinical effects of rovunaptabin, also known as BC007 on fatigue and quality of life in patients with Post-COVID syndrome (reCOVer): a prospective, exploratory, placebo-controlled, double-blind, randomised phase IIa clinical trial (RCT).

IF 10 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

EClinicalMedicine Pub Date : 2025-07-22 eCollection Date: 2025-08-01 DOI:10.1016/j.eclinm.2025.103358

Bettina Hohberger, Marion Ganslmayer, Thomas Harrer, Friedrich Kruse, Stefanie Maas, Tobias Borst, Ralph Heimke-Brinck, Andreas Stog, Thomas Knauer, Eva Rühl, Victoria Zeisberg, Adam Skornia, Alexander Bartsch, Armin Ströbel, Monika Wytopil, Caroline Merkel, Sophia Hofmann, Katja G Schmidt, Petra Lakatos, Julia Schottenhamml, Martin Herrmann, Christian Mardin, Jürgen Rech

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引用次数: 0

Abstract

Background: Rovunaptabin neutralises functional autoantibodies targeting G-Protein coupled receptors (GPCR-fAAbs), observed in patients with Post-COVID syndrome. As we hypothesise an improvement of PCS by rovunaptabin, the aim of reCOVer was to investigate safety, tolerability, and clinical effects of rovunaptabin in PCS patients.

Methods: reCOVer is a prospective, exploratory, placebo-controlled, double-blind, randomised phase IIa clinical investigator initiated trial with 1350 mg rovunaptabin with additional cross-over at the Universitätsklinikum Erlangen, Germany. The trial was registered in EudraCT, 2022-001781-35. Screening was done between 21·11·2023 and 25·06·2024. Eligible participants (18-80 years) showed GPCR-fAAbs, at least 3/8 defined PCS symptoms persisting ≥3 months after COVID-19 and fatigue as major symptom. Participants were randomly assigned (1:1) to either receive rovunaptabin or placebo at day 0 (d0) and d48 with a follow-up of 28 days, respectively. Primary endpoint was the number of treatment emergent adverse events (TEAE) at d28 (co-primary endpoint: TEAE at d70); secondary endpoint focused on fatigue and quality of life.

Findings: Thirty PCS patients were randomised and analysed. RCT analysis showed nine (rovunaptabin) and five TEAEs (placebo), yet without statistically significance (p = 0·1299; CI -14·80%; 63·02%); one serious adverse event, not related to treatment, was recorded. Rovunaptabin showed a neutralisation of GPCR-fAAb and a significant improvement of FACIT Fatigue Scale (effect size = 2·10, p = 0·0378), Bell score (effect size = 3·64, p = 0·0004), Fatigue Severity Scale (effect size = -2·66, p = 0·0088), and quality of life (4/8 items).

Interpretation: As this proof-of-concept study showed effects on the patient-centred endpoint PCS and a good safety profil, subsequent studies are needed to confirm these results in a larger cohort.

Funding: German Federal Ministry of Education and Research, German Research Foundation.

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rovunaptabin（也称为BC007）对covid后综合征（reCOVer）患者疲劳和生活质量的安全性、耐受性和临床影响：一项前瞻性、探索性、安慰剂对照、双盲、随机IIa期临床试验（RCT）。

背景：在covid后综合征患者中观察到Rovunaptabin中和针对g蛋白偶联受体（GPCR-fAAbs）的功能性自身抗体。由于我们假设罗韦那他滨可以改善PCS，因此reCOVer的目的是研究罗韦那他滨在PCS患者中的安全性、耐受性和临床效果。方法：reCOVer是一项前瞻性、探索性、安慰剂对照、双盲、随机IIa期临床研究者启动的试验，在Universitätsklinikum Erlangen，使用1350 mg rovunaptabin进行额外交叉。该试验已在EudraCT注册，编号为2022-001781-35。筛查时间为2023年11月21日至2024年6月25日。符合条件的参与者（18-80岁）显示GPCR-fAAbs，至少3/8的定义的PCS症状在COVID-19后持续≥3个月，疲劳是主要症状。参与者被随机分配（1:1），分别在第0天（d0）和第48天接受rovunaptabin或安慰剂，随访28天。主要终点是28 d28时的治疗紧急不良事件（TEAE）数量（共同主要终点：70 d70时的TEAE）；次要终点关注疲劳和生活质量。结果：随机选取30例PCS患者进行分析。RCT分析显示9个teae（罗那他滨）和5个teae（安慰剂），但无统计学意义(p = 0.1299；CI -14·80%;63·02%);记录了一个与治疗无关的严重不良事件。Rovunaptabin对GPCR-fAAb有中和作用，对FACIT疲劳量表（效应量= 2.10,p = 0.0378）、Bell评分（效应量= 3.64,p = 0.00004）、疲劳严重程度量表（效应量= -2·66,p = 0.0088）和生活质量（4/8项）有显著改善。解释：由于这项概念验证研究显示了对以患者为中心的终点PCS的影响和良好的安全性，因此需要后续研究在更大的队列中证实这些结果。资助：德国联邦教育和研究部，德国研究基金会。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.