NCT05911009

To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID

A Prospective, Double-blind, Randomized, Parallel Group, Placebo Controlled, Multicentre, Phase II Study to Investigate the Efficacy, GPCR Autoantibody Neutralizing Effect, Safety, and Tolerability of BC 007 in Participants With Long COVID

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Berlin Cures GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an interventional, randomized, multinational, multicenter, double-blind, phase 2 study with a follow-up period of 90 days. The intension of this clinical trial is to investigate the long-term sequelae (named Long COVID syndrome; post COVID or PASC) of an infection with Corona Virus Type 2 that has resulted in a condition known as Severe Acute Respiratory Syndrome Corona Virus Type 2 (SARS-CoV-2). The purpose of this study is to evaluate the efficacy and safety of BC 007 as a treatment for long-lasting COVID-symptoms in patients who were neither intubated nor supported with extracorporeal blood oxygenation (ECMO) during their acute COVID-19 infection. The study drug acts by neutralizing functional autoantibodies directed against G-protein coupled receptors (GPCRs). Neutralization of the autoantibodies is expected to induce a beneficial effect on symptoms typically seen in patients with long COVID syndrome. Functional autoantibodies are proteins belonging to the class of G-type immunoglobulins that can be synthesized by activation of the immune system and can induce various pathogenic activities by binding to one of the extracellular loops of G-proteins (GPCR-AAB). The study consists of a screening phase of up to 35 days, treatment (two administrations by intravenous infusion at two-week intervals either with the study drug (BC 007) or with placebo (NaCl 0.9%), with an initial follow-up period of 15 days after each administration and an extended follow-up period of 60 days. Patients are required to visit the study center for follow-up visits at specified intervals. For the entire study duration of 125 days from screening to the end of the study, 8 site visits are planned.

Conditions

• Long Covid

Interventions

Type	Name	Description
DRUG	BC 007 or matching placebo	Participants will be treated with two infusions of BC 007 or placebo two weeks apart, according to a double-blind design

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-06-26
• Completion: 2024-09-04
• First posted: 2023-06-20
• Last updated: 2024-11-18

Locations

16 sites across 5 countries: Austria, Finland, Germany, Spain, Switzerland