Feasibility, Safety, and Effectiveness of Prednisolone and Vitamin B1, B6, and B12 in Patients with Post-COVID-19 Syndrome (PreVitaCOV): A Multicenter Randomized Controlled Trial in Primary Care

Andreas Klug, Alexander Schwager, Karl Georg Häusler, Cornelia Fießler, Peter Heuschmann, Hanna Kaduszkiewicz, Walter Maetzler, Stefanie Joos, Christian Förster, Oliver Zolk, Ildikó Gágyor

Keywords: Post-COVID-19-Syndrome, Prednisolone, Vitamin B, primary care, RCT

Background:

Post-COVID-19 syndrome (PC19S) is characterized by persistent symptoms such as fatigue, dyspnea and cognitive impairment. Despite increased prevalence, evidence-based treatment options remain scarce. PreVitaCOV aimed to evaluate the feasibility of a randomized controlled therapeutic trial (RCT) in primary care and the effect of prednisolone and/or vitamin B complex in patients with PC19S.

Research questions:

Is administering vitamin B1/B6/B12, and/or prednisolone for patients with PC19S within a RCT feasible in primary care? Are these interventions effective in reducing symptoms and improving quality of life?

Method:

This double-blind multicenter RCT was conducted at three sites in Germany. Adult patients with documented SARS-CoV-2 infection ≥12 weeks ago and persistent symptoms were randomized into one of four treatment arms: prednisolone, vitamin B complex, both or placebo for 28 days. The study was divided into two phases: (1) a pilot phase assessing the feasibility of recruitment in primary care, defined by a retention rate of ≥85% at day 28 (2) a confirmatory phase evaluating the treatment effect. Primary outcome of the confirmatory phase was change in symptom severity from baseline to day 28 (PROMIS). Secondary outcomes included quality of life (EQ-5D), functional status (PCFS), depression (PHQ-8), fatigue (Chalder Fatigue Scale), physical performance (1-minute sit-to-stand test) and pain intensity (NRS).

Results:

2435 patients were screened, 321 included. 64% of participants were female. In the pilot phase, 100 patients were enrolled. A 97% retention rate was achieved at day 28. Adherence to the treatment protocol was high, with 92% of participants taking at least 26 of 28 doses as required. Further results will be reported at the conference.

Conclusions:

The pilot phase of PreVitaCOV demonstrated the feasibility of the RCT with PC19S patients in primary care. Its success and ongoing analysis of the confirmatory phase address a critical gap in evidence-based treatment options for this challenging condition.

Points for discussion:

What factors contributed to the high retention and adherence rates in this trial, and how can these be replicated in future primary care-based RCTs?

How do the outcomes (e.g., symptom severity, quality of life, functional status) align with the health limitations of patients suffering from PC19S?

What implications does the gender disparity have for understanding the prevalence and impact of PC19S?

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