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

NCT05911009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-11-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Berlin Cures GmbH

    lead INDUSTRY

Principal Investigators

  • Axel Mescheder, Dr. · CMO Berlin Cures GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2024-06-26
Completion
2024-09-04

Countries

  • Austria
  • Finland
  • Germany
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911009 on ClinicalTrials.gov