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
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 |