Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05911009

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
See also
  Status Clinical Trial Phase
Recruiting NCT05926505 - Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syndrome Phase 2/Phase 3
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Completed NCT05552612 - Health-related Quality of Life and Long COVID
Completed NCT05531019 - COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A N/A
Not yet recruiting NCT04949386 - Safety, Tolerability and Efficacy of S-1226 in Post-COVID-19 Subjects With Persistent Respiratory Symptoms. Phase 2
Recruiting NCT06118112 - Living With Long COVID: LONGCOVID-EXPERIENCE
Completed NCT05185674 - Sociodemographic, Clinical, Quality of Life and Health Care Conditions in COVID-19 Survivors.
Active, not recruiting NCT05965752 - RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms N/A
Active, not recruiting NCT05965739 - RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms N/A
Completed NCT05812209 - Stellate Ganglion Block to Treat Long COVID 19 Case Series
Recruiting NCT05606211 - Pain in Long COVID-19: The Role of Sleep
Active, not recruiting NCT05713266 - Using Data From a Multisensor Rapid Health Assessment Device to Predict Decompensation in Long COVID (AIDI)
Completed NCT05601180 - Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID. N/A
Completed NCT05679505 - Vagus Nerve Stimulation for Post-COVID Syndrome N/A
Not yet recruiting NCT06045338 - Mind Body Intervention for Long COVID N/A
Recruiting NCT06091358 - Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation. N/A
Recruiting NCT05566392 - Longterm Influence of Pediatric Long COVID Syndrome
Recruiting NCT05855369 - Smell Training and Trigeminal Nerve Stimulation for COVID-related Smell Loss Phase 2/Phase 3
Recruiting NCT05572346 - Digital App for Telerehabilitation in Respiratory Diseases
Recruiting NCT06316843 - Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 Phase 2