Prospective, exploratory, randomized, controlled, double-blind, phase IIa clinical trial in a cross-over design to evaluate the safety and tolerability and potential clinical effects of BC007 in patients with post-COVID syndrome

Project description

reCOVer is a prospective, exploratory, placebo-controlled, double-blind, randomised phase IIa clinical investigator initiated trial with 1350 mg rovunaptabin with additional cross-over. Screening was done between 21 November 2023 and 25 June 2024. Eligible participants (18–80 years) showed G-protein coupled receptor (GPCR) antiboides, at least 3/8 defined post-COVID syndrome symptoms persisting ≥3 months after COVID-19 and fatigue as a major symptom.

Participants were randomly assigned (1:1) to either receive rovunaptabin or placebo at day 0 and 48, with a follow-up of 28 days, respectively. Primary endpoint was the number of treatment emergent adverse events (TEAE) at day 28, secondary endpoints focused on fatigue and quality of life.

Description adapted from publication: see link below.