Prednisolone and vitamin B1, B6, and B12 in patients with Post-COVID-19-Syndrome (PC19S) – a randomized controlled trial in primary care

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• 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,
ASS
• 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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1: feasibility of screening and recruitment in primary care (retention rate of at least 85% at day 28) <br>Phase 2: change of symptom severity as assessed by a specifically tailored Pa-tient Reported Outcomes Measurement Information System (PROMIS) total score referring to five symptom domains known to be typical for PC19S (fatigue, dyspnoea, cognition, anxiety, depression) from baseline to day 28

Secondary Outcome Measures

Name	Time	Method

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