DRKS00029617招募中2 期
Prednisolone and vitamin B1, B6, and B12 in patients with Post-COVID-19-Syndrome (PC19S) – a randomized controlled trial in primary care - PreVitaCOV
niversitätsklinikum Würzburg, Institut für Allgemeinmedizin0 个研究点目标入组 300 人开始时间: 2022年11月10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
- 300
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 one（—）
- 性别
- All
入选标准
- •1. adult patients (at least 18 years old)
- •2. history of SARS-CoV-2 infection at least 12 weeks ago (if patients had more than one infection with SARS-CoV-2 the 12 weeks refer to the infection causing the Post-COVID-19 symptoms); the infection must be documented by either a positive PCR or Antibody-Test or be confirmed by the patient’s General Practitioner
- •3. symptoms concerning at least one of the following domains: fatigue, dyspnea,
- •cognition, anxiety, depression
- •4. Above mentioned symptom(s) that developed during or after the SARS-CoV-2
- •infection, that persist until study inclusion, and that are associated with COVID-
- •19 as assessed by the patients’ GP or the local investigator
排除标准
- •acute Coronavirus disease (COVID-19) at baseline visit (rapid SARS-CoV-
- •2 antigen test)
- •patients who were treated in the intensive care unit because of COVID-19
- •pregnancy/ breastfeeding
- •diabetes mellitus
- •PC19S symptoms that can be explained by an alternative diagnosis (e.g.,
- •chronic fatigue syndrome, depression, active or preceding cancer therapy,
- •severe anemia, sleep apnea syndrome) as assessed by the patients’ GP or
- •the investigator
- •History of severe medical conditions such as
- •concomitant acute infectious disease
- •gastrointestinal ulcer
- •liver disease/ liver cirrhosis
- •malabsorption or condition after bariatric surgery
- •chronic airway disease [e.g., Chronic Obstructive Pulmonary Disease
- •(COPD), Asthma)
- •chronic heart failure [New York Heart Association (NYHA) III and IV]
- •neurological disorders
- •untreated hypothyroidism
- •significantly impaired glucuronidation (e.g., Gilbert-Meulengracht, ROTOR,
- •or Crigler-Najjar syndrome)
- •immunodeficiency or a chronically weakened immune system [e.g., acquired
- •immunodeficiency syndrome (AIDS), HIV, lymphoma, chemo-radiotherapy,
- •immunosuppressive pathology]
- •mental disorders
- •active cancer
- •any other severe medical conditions that preclude participation as determined
- •by responsible physiciancurrent use of
- •immunosuppressive drugs
- •non-steroidal antiinflammatory drugs (NSAID)
- •fluoroquinolones
- •anticoagulation: phenprocoumon or other cumarin derivates, direct oral anticoagulants,
- •any other drug that could exhibit clinically relevant interactions with the study medication (as described in Fachinformation Prednisolon STADA®, Predni H Tablinen® Zentiva or Fachinformation Vitamin B komplex Hevert). The decision on the clinical relevance of the interactions is at the discretion of the clinical investigator.
- •systemic treatment with prednisolone for at least 7 days or any parenteral application since the end of the acute phase of COVID-19; treatment with vitamins B1, B6, or B12 in doses equivalent to the dose of the study medication for at least 7 days or any parenteral application since the end of the
- •acute phase of COVID-19; vitamin supplements containing vitamin B1, B6, or B12 should have been ceased at least 4 weeks prior to the inclusion of the study.
- •known allergy and contraindications to the intervention drugs
- •need of care and/or peer dependency
- •nursing home residents
- •inability to understand the scope of the study, to follow study procedures
- •and to give informed consent or to attend the study sites
- •participation in another interventional trial at the same time or within the past
- •3 months before enrolment
- •female patients considering to get pregnant during the first month of the trial
- •and within 1 week after the last dose of study drug(s)
研究者
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