Prospective, exploratory, randomized, controlled, double-blind, phase IIa clinical trial in a cross-over design to evaluate the safety and tolerability and potential clinical effects of BC007 in patients with post-COVID syndrome.
- Conditions
- Post-COVID-Syndrome
- Registration Number
- DRKS00032237
- Lead Sponsor
- niversitätsklinikum Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Age: 18-80 years
- Male or female
- The subject is mentally capable of understanding the nature and content of the clinical trial and of following the instructions of the study personnel.
- Presence of the subject's written informed consent from the investigator or a medical member of the study team.
- Z.n. SARS-CoV-2 infection confirmed by positive PCR test at the time of acute infection.
- Z.n. COVID-19 with onset of illness at least 12 weeks prior to study inclusion.
- Post-COVID-19 persisting* or developing symptoms of post-COVID syndrome, with clinically relevant fatigue with a Bell Score = 60 and history of at least three of the following symptoms:
o Exercise intolerance
o exertional dyspnea
o concentration disturbances
o so-called brain fog
o fatigue
o gait unsteadiness
o disturbances of the sense of taste and/or smell
o headache
*Persistence of symptoms > 12 weeks after onset of COVID-19.
- Presence of functional GPCR-Ab. Pre-existing findings from participation in the disCOVer health services research project, among others, may be used at the discretion of the investigator.
- Presence of a current negative SARS-CoV-2 antigen test (max. 24 hrs old).
- Participants must also meet at least one of the following criteria:
o Menopause (at least twelve months of natural amenorrhea or six months of amenorrhea with serum FSH >40mU/ml) or
o Status post bilateral ovariectomy or hysterectomy for at least six weeks prior to screening appointment (visit 1, day -7±6 days), or
o Regular, correct, and reliable use of a contraceptive method with a failure rate =1% per year (e.g., implants, depot injections, intrauterine devices, hormonal coils); or
o Vasectomy of the partner.
- Therapeutic anticoagulation with heparin, Marcumar, DOAK or regular use of other drugs with influence on blood coagulation in the last 2 weeks before the screening visit
- Known hypersensitivity to any of the ingredients of the investigational product or to drugs with similar chemical structure
- History of other known disease or cause of fatigue and decreased exercise tolerance, such as multiple sclerosis, anemia
- History of obstructive sleep apnea syndrome
- Obesity with a BMI = 30 kg/m2.
- Clinical evidence of presence of severe acute or subacute organ damage to the heart and lungs
- Presence of a serious medical condition that, in the judgment of the investigator, would make study inclusion a disproportionately high risk for the affected patient
- Malignant disease under ongoing oncological therapy
- Malignant disease in remission with moderate to high risk of recurrence within the last 2 years prior to screening
- Pregnancy and lactation
- Lack of willingness to use reliable methods of contraception during and up to 3 months after the end of study participation (applies to all participants)
- Persons in a dependent or employment relationship with the authorized representative of the sponsor or the study site (insofar no participation of employees of the Department of Ophthalmology of the University Hospital Erlangen)
- Planned prolonged stay outside the region that prevents compliance with the visit schedule.
- Participation in another clinical trial or administration of an unapproved agent within the last 4 weeks before the screening appointment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of treatment-emergent adverse events (TEAE) in the period from V2 (after administration of the investigational product) to V7 comparing arm A (verum -> placebo) and arm B (placebo -> verum).
- Secondary Outcome Measures
Name Time Method - Change in fatigue symptomatology determined using the <br>- Bell scale <br>- Canadian Criteria<br>- Chalder Fatigue Scale <br>- FACIT Fatigue Scale<br>- Fatigue Severity Scale<br>- Change in quality of life determined by the SF-36 questionnaire <br>- Change in exercise capacity determined by the 6-MWT (walking distance, Borg scales)<br>- Change in microcirculation determined by vessel density in the capillary plexus of the macula and/or around the optic nerve in the OCT-A scan. <br>- Qualitative determination of functional GPCR autoantibodies (detectable/not detectable) <br>- Occurrence of AEs, ARs, SAEs and SARs during the whole observation period