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

Long Covid Clinical Trial

Official title:
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

Clinical Trial Summary

This study is an interventional, randomized, multinational, multicenter, double-blind, phase 2 study with a follow-up period of circa 12 months. 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 330 days. Patients are required to visit the study center for follow-up visits at specified intervals. For the entire study duration of 395 days from screening to the end of the study, 11 site visits are planned.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05911009
Study type Interventional
Source Berlin Cures GmbH
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 16, 2023
Completion date May 31, 2025
View Details
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