Viewing Study NCT05911009



Ignite Creation Date: 2024-05-06 @ 7:09 PM
Last Modification Date: 2024-10-26 @ 3:01 PM
Study NCT ID: NCT05911009
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-07-09
First Post: 2023-06-15

Brief Title: To Investigate Efficacy Pharmacodynamics and Safety of BC 007 in Participants With Long COVID
Sponsor: Berlin Cures GmbH
Organization: Berlin Cures GmbH

Study Overview

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
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BLOC
Brief 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 09 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2022-003452-14 EUDRACT_NUMBER None None