Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome

Prior treatment

• 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
  • chronic heart failure \[New York Heart Association (NYHA) III and IV\]
  • neurological disorders
  • untreated hypothyroidism
  • significantly impaired glucuronidation
  • immunodeficiency or a chronically weakened immune system
  • mental disorders
  • active cancer
  • any other severe medical conditions that preclude participation as determined by responsible physician
• current use of
  • immunosuppressive drugs
  • non-steroidal antiinflammatory drugs (NSAID)
  • fluoroquinolones
  • anticoagulation
  • 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 medi-cation 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
• 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)

Other illness

• acute Coronavirus disease (COVID-19) at baseline visit
• patients who were treated in the intensive care unit because of COVID-19
• diabetes mellitus
• known allergies and contraindications to the intervention drugs

Other

• pregnancy/ breastfeeding
• PC19S symptoms that can be explained by an alternative diagnosis
• 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

• adult patients (at least 18 years old)
• history of SARS-CoV-2 infection at least 12 weeks ago (the infection must be documented by either a positive PCR or antibody-Test or be confirmed by the patient's GP)
• symptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depression
• 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' general practitioner or the local investigator