The following is a summary of “Feasibility, safety, and effectiveness of prednisolone and vitamin B1, B6, and B12 in patients with post-COVID-19-syndrome (PreVitaCOV) – protocol of a randomized, double-blind, placebo-controlled multicentre trial in primary care (phase IIIb),” published in the January 2024 issue of Infectious Disease by Tengelmann et al.
Following SARS-CoV-2 infection, a notable proportion of individuals experience lingering symptoms known as post-COVID-19 syndrome (PC19S). There is ongoing exploration into potential treatments, including neurotropic vitamins and anti-inflammatory substances. The PreVitaCOV trial aims to evaluate the feasibility, safety, and effectiveness of administering prednisolone and/or vitamin B1, B6, and B12 to patients in primary care settings.
The trial, designed as a phase IIIb, multicenter, randomized, double-blind, and placebo-controlled study, adopts a two-phase approach with a factorial design. A preliminary pilot phase assessed feasibility and safety, establishing a confirmatory phase to assess effectiveness after confirming feasibility. Eligible adult patients with PC19S, documented at least 12 weeks after a SARS-CoV-2 infection, are randomly assigned to four treatment groups: prednisolone 20 mg for five days followed by 5 mg for 23 days (trial drug 1), B vitamins (B1 [100 mg OD], B6 [50 mg OD], and B12 [500 µg OD]) for 28 days (trial drug 2), a combination of trial drugs 1 and 2, or placebo.
The pilot phase’s primary outcome was the retention rate of the initial 100 patients, which surpassed the confirmation criterion of ≥85%, achieving a rate of 98%. Consequently, the confirmatory phase involves enrolling an additional 240 patients. The primary outcome measure evaluates the change in symptom severity from baseline to day 28, focusing on fatigue, dyspnea, cognition, anxiety, and depression using a tailored Patient Reported Outcomes Measurement Information System (PROMIS) total score. The confirmatory phase aims to show the superiority of any treatment over placebo, indicating an improvement of at least 3 points on the PROMIS total score.
The PreVitaCOV trial’s findings are expected to offer insights into therapeutic strategies for PC19S within primary care contexts.
Source: bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-023-08925-2
