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COMPLETEDPHASE2

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

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

NCT05911009•Berlin Cures GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant is eligible to be included in the study only if all the following criteria apply:
•1. The participant provides written informed consent prior to any clinical study-specific procedures.
•2. The participant is a male or female, ≥18 years of age, at the time of signing the informed consent form.
•3. All male and female participants of childbearing potential must be willing to use effective methods of contraception from the start of Screening until EOS (Day 90). Male participants must refrain from donating sperm during this period.
•4. Acute phase of COVID-19 ended at least 3 months prior to dosing.
•5. The participant has a confirmed negative SARS-CoV-2 test result (polymerase chain reaction \[PCR\] test) at screening.
•6. The participant provides a documented positive SARS-CoV-2 test result (reverse transcriptase \[RT\]-PCR or rapid antigen test) at Screening. For participants with long COVID symptoms who cannot provide certified evidence, a positive antibody test for nucleocapsid protein IgG must demonstrate a history of SARS CoV 2 infection; this test can be performed as part of the Screening procedure. The participant reports persistence or new onset of symptoms after a SARS-CoV-2 infection, with these symptoms lasting for at least 2 consecutive months (being persistent, recurrent, or of varying severity within that period) with no other explanation, as defined by WHO, and not being present prior to COVID-19 infection.
•7. Participant is screened positive for GPCR-AAB activity by Berlin Cures laboratory.
•8. Participant has not been intubated or received ECMO support during their acute COVID-19 infection.
•9. Participant screens positive for fatigue (FACIT-FS score \<35) and presents with at least one additional symptom from the symptom score sheet (COA) which has persisted for more than 12 weeks.
+13 more criteria

Exclusion Criteria

•Participant is excluded from the study if any of the following criteria apply:
•1. Postural Orthostatic Tachycardia Syndrome existing prior to the initial SARS CoV 2 infection leading to long COVID, as per medical history. History or evidence of any clinically significant cardiovascular disease.
•2. Any history or presence of gastrointestinal, endocrinologic (Type 1 diabetes,), cardiovascular, haematologic, hepatic, immunologic, metabolic (specifically gout), urologic, pulmonary (asthma), neurologic, dermatologic, renal and/or other major disease , as judged by the Investigator before SARS-CoV-2 infection. Other clinically stable conditions, which do not affect the study assessments may be allowed as judged by the Investigator after discussion with the medical monitor.
•Possible allowed diseases are (if stable and well-controlled) include but are not limited to:
•* Respiratory disorders (e.g., asthma-like) that first appear with long COVID.
•* Mild hypertension (\<160 mmHg systolic, \<100 mmHg diastolic) without known organ or vessel damage.
•* Non-insulin-dependent diabetes mellitus without known organ or vessel damage.
•* Glaucoma.
•* Hypercholesterolemia/hypertriglyceridemia.
•* Hypothyreosis
+18 more criteria

Locations (16)

Klinik Favoriten - Wiener Gesundheitsverbund

Vienna, Austria

Klinik Floridsdorf - Wiener Gesundheitsverbund

Vienna, Austria

Terveystalo Helsinki Sleep Clinic

Helsinki, Nyland and Tavastehus County, Finland

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Universitätsklinikum Jena

Jena, Thuringia, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Key Dates

Start Date

June 16, 2023

Primary Completion Date

June 26, 2024

Completion Date

September 4, 2024

Last Updated

November 18, 2024

Enrollment

119

ACTUAL participants

Conditions

Long Covid

Interventions

BC 007 or matching placebo

DRUG

Taurine Supplementation in Long COVID

NCT06721949

Long COVID

View study

RECRUITINGPHASE3

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Taurine Supplementation in Long COVID

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome

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