Study to investigate tolerability and possible effects of BC007 in patients with post-COVID syndrome

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 - reCOVer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001781-35-DE

Enrollment

Registered

2023-01-30

Start date

2023-05-16

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-COVID syndrome MedDRA version: 24.0 Level: LLT Classification code 10085505 Term: Post-COVID syndrome System Organ Class: 100000004862

Interventions

Product Name: BC007 Product Code: BC007 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: NAP CAS Number: 145563-68-4 Current Sponsor code: BC 007 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate safety and tolerability of BC007 in patients with post-COVID syndrome;Secondary Objective: 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]);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).;Timepoint(s) of evaluation of this end point: Visit 7 (day 28 ± 3 days) Visit 13 (day 70) co-primary endpoint	—

Measure

Time frame

Main Objective: to evaluate safety and tolerability of BC007 in patients with post-COVID syndrome;Secondary Objective: 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]);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).;Timepoint(s) of evaluation of this end point: Visit 7 (day 28 ± 3 days) Visit 13 (day 70) co-primary endpoint

—

Secondary

Measure	Time frame
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);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])	—

Measure

Time frame

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);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])

—

Countries

Germany

Contacts

Public ContactAugenklinik

Universitätsklinikum Erlangen

bettina.hohberger@uk-erlangen.de004991318544497

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026