DRKS00032237招募中2 期
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. - reCOVer
niversitätsklinikum Erlangen0 个研究点目标入组 30 人开始时间: 2023年9月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •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 gait unsteadiness
- •o disturbances of the sense of taste and/or smell
- •*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.
排除标准
- •- 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.
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