Clinical Trial Page

Summary
EudraCT Number:2022-001781-35
Sponsor's Protocol Code Number:UKER-BC007-01
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2023-01-30
Trial results
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2022-001781-35
A.3Full title of the trial
Prospective, explorative, randomized, controlled, double-blind, cross-over phase IIa clinical trial to investigate safety and tolerability as well as potential clinical effects of BC007 in patients with post-COVID syndrome
Prospektive, explorative, randomisierte, kontrollierte, doppelblinde klinische Prüfung der Phase IIa im Cross-over Design zur Untersuchung der Sicherheit und Verträglichkeit sowie möglicher klinischer Effekte von BC007 bei Patienten mit Post-COVID-Syndrom
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Study to investigate tolerability and possible effects of BC007 in patients with post-COVID syndrome
Studie zur Untersuchung der Verträglichkeit sowie der möglichen Wirkung von BC007 bei Patienten mit Post-COVID-Syndrom
A.3.2Name or abbreviated title of the trial where available
reCOVer
reCOVer
A.4.1Sponsor's protocol code numberUKER-BC007-01
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorUniversitätsklinikum Erlangen
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportBMBF
B.4.2CountryGermany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationUniversitätsklinikum Erlangen
B.5.2Functional name of contact pointAugenklinik
B.5.3 Address:
B.5.3.1Street AddressSchwabachanlage 6
B.5.3.2Town/ cityErlangen
B.5.3.3Post code91054
B.5.3.4CountryGermany
B.5.4Telephone number004991318544497
B.5.6E-mailbettina.hohberger@uk-erlangen.de
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBC007
D.3.2Product code BC007
D.3.4Pharmaceutical form Lyophilisate for solution for infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNAP
D.3.9.1CAS number 145563-68-4
D.3.9.2Current sponsor codeBC 007
D.3.9.3Other descriptive named(GGTTGGTGTGGTTGG)
D.3.9.4EV Substance CodeSUB267654
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSolution for infusion
D.8.4Route of administration of the placeboIntravenous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Post-COVID syndrome
Post-COVID-Syndrom
E.1.1.1Medical condition in easily understood language
Permanent health limitations after COVID-19
Bleibende gesundheitliche Einschränkungen nach COVID-19
E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 24.0
E.1.2Level LLT
E.1.2Classification code 10085505
E.1.2Term Post-COVID syndrome
E.1.2System Organ Class 100000004862
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
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.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial 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
LSLV
LSLV
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years0
E.8.9.1In the Member State concerned months11
E.8.9.1In the Member State concerned days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 25
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 5
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state30
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
standard of care will be provided by the patient´s general practitioner
Die weitere Behandlung erfolgt durch den jeweiligen betreuenden Haus- bzw. Facharzt des Patienten
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2023-05-16
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-02-27
P. End of Trial
P.End of Trial StatusOngoing
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