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)Research in context
Summary: 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 clinica...
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2025-08-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Bettina Hohberger |
| collection | DOAJ |
| description | Summary: 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. |
| format | Article |
| id | doaj-art-8dbb632a597040cfaa4f067cfd38b53b |
| institution | Kabale University |
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| publishDate | 2025-08-01 |
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| spelling | doaj-art-8dbb632a597040cfaa4f067cfd38b53b2025-08-20T03:25:52ZengElsevierEClinicalMedicine2589-53702025-08-018610335810.1016/j.eclinm.2025.103358Safety, 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)Research in contextBettina Hohberger0Marion Ganslmayer1Thomas Harrer2Friedrich Kruse3Stefanie Maas4Tobias Borst5Ralph Heimke-Brinck6Andreas Stog7Thomas Knauer8Eva Rühl9Victoria Zeisberg10Adam Skornia11Alexander Bartsch12Armin Ströbel13Monika Wytopil14Caroline Merkel15Sophia Hofmann16Katja G. Schmidt17Petra Lakatos18Julia Schottenhamml19Martin Herrmann20Christian Mardin21Jürgen Rech22Department of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany; Deutsches Zentrum für Immuntherapie (DZI), Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Germany; Corresponding author. Department of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany.Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDeutsches Zentrum für Immuntherapie (DZI), Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Germany; Infectious Diseases and Immunodeficiency Section, Department of Medicine 3, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany; Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyCentre for Clinical Studies (CCS), Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyPharmacy of the University Hospital Erlangen, Uniklinikum Erlangen, Erlangen, GermanyPharmacy of the University Hospital Erlangen, Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyCentre for Clinical Studies (CCS), Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany; Institute of Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Medicine 2, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany; Infectious Diseases and Immunodeficiency Section, Department of Medicine 3, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany; Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDeutsches Zentrum für Immuntherapie (DZI), Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Germany; Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDepartment of Ophthalmology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanyDeutsches Zentrum für Immuntherapie (DZI), Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Germany; Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, GermanySummary: 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.http://www.sciencedirect.com/science/article/pii/S2589537025002901Post-COVID syndromeLong-COVIDRovunaptabinPCS subtypesGPCRFunctional autoantibody |
| spellingShingle | 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 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)Research in context EClinicalMedicine Post-COVID syndrome Long-COVID Rovunaptabin PCS subtypes GPCR Functional autoantibody |
| title | 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)Research in context |
| title_full | 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)Research in context |
| title_fullStr | 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)Research in context |
| title_full_unstemmed | 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)Research in context |
| title_short | 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)Research in context |
| title_sort | 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 research in context |
| topic | Post-COVID syndrome Long-COVID Rovunaptabin PCS subtypes GPCR Functional autoantibody |
| url | http://www.sciencedirect.com/science/article/pii/S2589537025002901 |
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