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Recruiting
NCT05638633
Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome
Conditions: Post-COVID-19 Syndrome
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 340
Sponsor: Wuerzburg University Hospital
Location: Germany
Summary
This is a multicenter, randomized, placebo controlled, double-blind phase III trial with four parallel groups studying studying the feasibility of RCT in primary care as well as the effectiveness of treatment with prednisolone and/or vitamin B1/6/12 for PC19S.
Eligibility Criteria
Inclusion Criteria:adult patients (at least 18 years old)history of documented SARS-CoV-2 infection at least 12 weeks agosymptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depressionAbove 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 investigatorExclusion Criteria:acute Coronavirus disease (COVID-19) at baseline visitpatients who were treated in the intensive care unit because of COVID-19pregnancy/ breastfeedingdiabetes mellitushypertensionPC19S symptoms that can be explained by an alternative diagnosisHistory of severe medical conditions such asconcomitant acute infectious diseasegastrointestinal ulcerliver disease/liver cirrhosismalabsorption or condition after bariatric surgerychronic airway diseasechronic heart failure [New York Heart Association (NYHA) III and IV]neurological disordersuntreated hypothyroidismsignificantly impaired glucuronidationimmunodeficiency or a chronically weakened immune systemmental disordersactive cancerany other severe medical conditions that preclude participation as determined by responsible physiciancurrent use ofimmunosuppressive drugsnon-steroidal antiinflammatory drugs (NSAID)fluoroquinolonesanticoagulationany other drug with a possible interaction with the study medicationcurrent or previous systemic treatment with any of the treatment drugs for at least seven days since COVID-19 or any parenteral applicationknown allergy and contraindications to the intervention drugsneed of care and/or peer dependencynursing home residentsinability to understand the scope of the study, to follow study procedures and to give informed consent or to attend the study sitesparticipation in another interventional trial at the same time or within the past 3 months before enrolmentfemale patients considering to get pregnant during the first month of the trial and within 1 week after the last dose of study drug(s)
Source: ClinicalTrials.gov (NCT05638633). StuddyBuddy aggregates publicly available trial information.