E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Post-COVID syndrome | Post-COVID-Syndrom | |
E.1.1.1 | Medical condition in easily understood language | Permanent health limitations after COVID-19 | Bleibende gesundheitliche Einschränkungen nach COVID-19 | |
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10085505 | E.1.2 | Term | Post-COVID syndrome | E.1.2 | System Organ Class | 100000004862 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | to evaluate safety and tolerability of BC007 in patients with post-COVID syndrome | Untersuchung der Sicherheit und Verträglichkeit von BC007 bei Patienten mit Post-COVID-Syndrom | |
E.2.2 | Secondary objectives of the trial | to evaluate potential effects of BC007 in patients with post-COVD syndome on •fatigue •quality of life •physical resilience, exertional intolerance, dyspnea •microcirculation (capillary plexus macula, N. opticus) •evidence of functional GPCR-autoantibodies Investigation of the safety of BC 007 during the entire observation period (baseline to V 14 [day 90]) | Untersuchung möglicher Effekte von BC007 bei Patienten mit Post-COVID Syndrom auf •die Fatigue-Symptomatik •die Lebensqualität •die körperliche Belastbarkeit bzw. Belastungsintoleranz, Dyspnoe •die Mikrozirkulation der Kapillarplexus am Auge (bestimmt im Kapillargebiet der Makula und um den Sehnerv) •den Nachweis von funktionellen GPCR-Autoantikörpern im Serum Untersuchung der Sicherheit von BC 007 im gesamten Beobachtungszeitraum (Baseline bis V 14 [Tag 90]) | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | Condition after SARS-CoV-2 infection (confirmed by PCR testing) Condition after COVID-19 (at least 12 weeks prior to enrolment) Symptoms of post-COVID syndrome: clinically relevant fatigue (Bell score ≤ 60) and aditionally at least three of the following symptoms: - exertional intolerance - exertional dyspnoe - concentration disorders - brain fog - exhaustion - aisle insecurity - taste or smell disorders - headache Presence of functional anti-GPCR autoantibodies | Z.n. SARS-CoV-2 Infektion, die zum Zeitpunkt der akuten Infektion durch positiven PCR-Test bestätigt wurde Z.n. COVID-19 mit Erkrankungsbeginn mindestens 12 Wochen vor Studieneinschluss Nach COVID-19 fortbestehende* oder sich entwickelnde Symptome eines Post-COVID-Syndroms, mit klinisch relevanter Fatigue mit einem Bell Score ≤ 60 und anamnestisch mindestens drei der folgenden Symptome: - Belastungsintoleranz - Belastungsdyspnoe - Konzentrationsstörungen - sog. brain fog - Abgeschlagenheit - Gangunsicherheit - Störungen des Geschmacks- und/oder Geruchssinns - Kopfschmerzen Vorliegen von funktionellen GPCR-AAb | |
E.4 | Principal exclusion criteria | Therapeutic anticoagulation with heparine, vitamin k antagonists, DOAK or intake of other drugs with effects on coagulation on a regular basis during the last 2 weeks prior to screening Medical history of a neurological-psychiatric or other disease that can be the cause of fatigue, listlessness, depression and reduced resilience, such as multiple sclerosis, Parkinson's disease, anaemia Serious disease for which study enrolment would pose a disproportional risk to the patient Clinical evidence of severe acute or subacute heart or lung damage Any medicinal product which might interfere with the study procedures Eye disorders which cause changes in microcirculation Systemic disorders with eye involvement | Therapeutische Antikoagulation mit Heparin, Marcumar, DOAK oder regelmäßige Einnahme von anderen Arzneimitteln mit Einfluss auf die Blutgerinnung in den letzten 2 Wochen vor der Screening-Visite Anamnestisch bekannte neurologisch-psychiatrische oder andere Erkrankung, die Ursache für Müdigkeit, Antriebslosigkeit, Depressionen und verminderte Belastbarkeit sein kann, wie z.B. Multiple Sklerose, M. Parkinson, Anämie Vorliegen einer schwerwiegenden Erkrankung, durch welche nach Beurteilung des Prüfers ein Studieneinschluss ein unverhältnismäßig hohes Risiko für den betroffenen Patienten darstellen würde Klinische Hinweise auf Vorliegen schwerer akuter oder subakuter Organschäden an Herz und Lunge Einnahme von Arzneimitteln, die nach Einschätzung des Prüfers mit den studienbedingten Maßnahmen interferieren könnten Augenerkrankungen mit Veränderungen der Mikrozirkulation Systemische Erkrankungen mit Augenbeteiligung | |
E.5 End points |
E.5.1 | Primary end point(s) | Evidence of TEAE between V2 (after IMP administration) and V7 compared between arm A (verum/placebo) and arm B (placebo//verum) Co-primary endpoint: Incidence of treatment-emergent adverse events (TEAE) from V2 (after administration of the investigational product) to V13 [day70] comparing arm A (verum/placebo) and arm B (placebo/verum). | Auftreten therapiebedingter unerwünschter Ereignisse (TEAE) im Zeitraum von V2 (nach Gabe des Prüfpräparats) bis V7 im Vergleich zwischen Arm A (Verum/Placebo) und Arm B (Placebo/Verum) Co-primärer Endpunkt: Auftreten therapiebedingter unerwünschter Ereignisse (TEAE) im Zeitraum von V2 (nach Gabe des Prüfpräparats) bis V13 [Tag70] im Vergleich zwischen Arm A (Verum/Placebo) und Arm B (Placebo/Verum). | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | Visit 7 (day 28 ± 3 days) Visit 13 (day 70) co-primary endpoint | Visite 7 (Tag 28 ± 3 Tage) Visite 13 (day 70) co-primärer Endpunkt | |
E.5.2 | Secondary end point(s) | Mean change and cross-over differences - of fatigue symptoms determined using the o Bell scale (V2 [day 0; baseline] vs. V7 [day 28] or V8 [day 42] vs. V13 [day 70]) o Canadian Criteria (V2 [day 0; baseline] vs. V7 [day 28] or V8 [day 42] vs. V13 [day 70]) o Chalder Fatigue Scale (V2 [day 0; baseline] vs. V7 [day 28] or V8 [day 42] vs. V13 [day 70]) o FACIT Fatigue Scale (V2 [day 0; baseline] vs. V7 [day 28] or V8 [day 42] vs. V13 [day 70]) o FSS (Fatigue Severity Scale) (V2 [day 0; baseline] vs. V7 [day 28] or V8 [day 42] vs. V13 [day 70]) - Quality of life as measured by the SF-36 questionnaire (V2 [day 0; baseline] vs. V7 [day 28] or V8 [day 42] vs. V13 [day 70]) - exercise capacity determined by the 6-MWT (walking distance, Borg scales); (V2 [day 0; baseline] vs. V7 [day 28] and V8 [day 42] vs. V13 [day 70]) - Microcirculation based on vessel density in the capillary plexus of the macula and/or around the optic nerve in the OCT-A scan (V2 [day 0; baseline] vs. V7 [day 28] and V8 [day 42] vs. V13 [day 70]). Qualitative determination of functional GPCR autoantibodies (detectable/not detectable) (V1 [screening], V5 [day 7], V7 [day 28], V11 [day 49], V13 [day 70]) Occurrence of AEs, ARs, SAEs and SARs in the entire observation period (baseline to V14 [day 90]) | Mittlere Veränderung und Cross-Over-Differenzen •der Fatigue-Symptomatik bestimmt anhand der oBell-Skala (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) oCanadian Criteria (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) oChalder Fatigue Scale (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) oFACIT Fatigue Scale (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) oFSS (Fatigue Severity Scale) (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) •der Lebensqualität bestimmt anhand des SF-36-Fragebogens (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) •der körperlichen Belastbarkeit bestimmt anhand des 6-MWT (Gehstrecke, Borg-Skalen); (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) •der Mikrozirkulation anhand der Gefäßdichte (vessel density) in den Kapillarplexus der Makula und/oder um den Sehnerv im OCT-A Scan (V2 [Tag 0; Baseline] vs. V7 [Tag 28] bzw. V8 [Tag 42] vs. V13 [Tag 70]) Qualitative Bestimmung von funktionellen GPCR-Autoantikörpern (nachweisbar/nicht nachweisbar) (V1 (Screening), V5 [Tag7], V7[Tag 28], V11 [Tag 49], V13 [Tag 70]) Auftreten von AEs, ARs, SAEs und SARs im gesamten Beobachtungszeitraum (Baseline bis V14 [Tag 90]) | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | Visit 2 (day 0), visit 4 (day 2), visit 5 (day 7), visit 6 (day 14 ±2 days), visit 7 (day 28 ±3 days), Cross over: visit 8 (day 42 ±7 days), visit 10 (day 44), visit 11 (day 49), visit 12 (day 56 ±2 days), visit 13 (day 70 ±3 days), EoS: visit 14 (day 91 ±14 days) | Visite 2 (Tag 0), Visite 4 (Tag 2), Visite 5 (Tag 7), Visite 6 (Tag 14 ±2 Tage), Visite 7 (Tag 28 ±3 Tage), Cross over: Visite 8 (Tag 42 ±7 Tage), Visite 10 (Tag 44), Visite 11 (Tag 49), Visite 12 (Tag 56 ±2 Tage), Visite 13 (Tag 70 ±3 Tage), EoS: Visite 14 (Tag 91 ±14 Tage) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 | The trial involves single site in the Member State concerned | Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |