CompletedPhase 3

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

Germany321 participantsStarted 2022-11-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. acute Coronavirus disease (COVID-19) at baseline visit
✕. 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
✕. History of severe medical conditions such as
✕. current use of
✕. 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

What they're measuring

Pilot phase: Proportion of participants retained after 28 days

Timeframe: 4 weeks

Confirmatory phase: Mean difference in PROMIS Total Score from day 0 to day 28

Timeframe: 4 weeks

Trial details

NCT IDNCT05638633

SponsorWuerzburg University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Post-COVID-19 Syndrome trials