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

NCT05911009 | Completed Phase 2 DMC

• 2 other identifiers: SBC007C4012022-003452-14
• Study Type: interventional
• Target: 119
• Locations: 5 countries
• Sites: 16

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 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

Long Covid

Keywords

Long Covid; Autoantibodies; Post-acute COVID-19 syndrome; BC 007; PASC

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in score on FACIT-FS scale at Day 30.

  To compare efficacy of BC 007 (double dose 1350 mg and double dose 1900 mg) with placebo based on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale in long COVID participants. FACIT-F is a five-point scale from 0 (not at all) to 4 (very much). The maximum composite scale is 52 (range 0 to 52). Higher scores mean a better outcome.

  Day 30

Secondary Outcomes (3)

• To compare GPCR AAB neutralizing effect of BC 007 1350 mg with that of placebo.

  at Days 3, 15, 17, 30, 60 and Day 90 post first infusion of study intervention.

• To compare GPCR AAB neutralizing effect of BC 007 1900 mg with that of placebo.

  at Days 3, 15, 17, 30, 60 and Day 90 post first infusion of study intervention.

• To compare GPCR-AAB neutralizing effect of BC 007 1350 mg with that of BC 007 1900 mg

  at Days 3, 15, 17, 30, 60 and Day 90 post first infusion of study intervention.

Study Arms (4)

1350mg BC 007 solution for infusion for 75-minutes intravenous infusion

EXPERIMENTAL

Drug: BC 007 or matching placebo

0.9% NaCl solution for infusion for 75-minutes intravenous infusion

PLACEBO COMPARATOR

Drug: BC 007 or matching placebo

1900mg BC 007 solution for infusion for 105-minutes intravenous infusion

EXPERIMENTAL

Drug: BC 007 or matching placebo

0.9% NaCl solution for infusion for 105-minutes intravenous infusion

PLACEBO COMPARATOR

Drug: BC 007 or matching placebo

Interventions

BC 007 or matching placebo DRUG

Participants will be treated with two infusions of BC 007 or placebo two weeks apart, according to a double-blind design

0.9% NaCl solution for infusion for 105-minutes intravenous infusion; 0.9% NaCl solution for infusion for 75-minutes intravenous infusion; 1350mg BC 007 solution for infusion for 75-minutes intravenous infusion; 1900mg BC 007 solution for infusion for 105-minutes intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is eligible to be included in the study only if all the following criteria apply:
• The participant provides written informed consent prior to any clinical study-specific procedures.
• The participant is a male or female, ≥18 years of age, at the time of signing the informed consent form.
• 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.
• Acute phase of COVID-19 ended at least 3 months prior to dosing.
• The participant has a confirmed negative SARS-CoV-2 test result (polymerase chain reaction \[PCR\] test) at screening.
• 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.
• Participant is screened positive for GPCR-AAB activity by Berlin Cures laboratory.
• Participant has not been intubated or received ECMO support during their acute COVID-19 infection.
• 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.
• Participant is not on any permanent medication(s) to treat chronic diseases that existed prior to COVID 19 infection. Exceptions are clinically stable conditions, which do not affect the study assessments and may be allowed as judged by the Investigator after discussion with the medical monitor. Clinically unstable is defined as a diagnosis or condition requiring changes in disease management within 2 months prior to start of Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. Concomitant treatment may be permitted, if
• A treatment (type and dose) remained unchanged within the 2 months before the start of Screening.
• No change in treatment is expected or required between Screening visit and Day 30 of the study.
• A treatment does not affect any of the study assessments, in particular by (e.g.,) causing fatigue or by impairing concentration ability.
• As judged by the Investigator and after discussion with the medical monitor, possible allowed concomitant medications include but are not limited to:

You may not qualify if:

• Participant is excluded from the study if any of the following criteria apply:
• 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.
• 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
• Participants with history of major active or chronic unstable psychiatric illness (e.g., but not limited to, depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year.
• Any history of any other chronic neurological, or psychological disease such as, but not limited to, chronic fatigue syndrome, fibromyalgia, lupus, Sjogren's syndrome.
• Any history or presence of relevant allergic reactions (e.g., requiring hospital stay, intravenous \[i.v.\] treatment or treatment with systemic steroids). A participant will not be included if it is likely that seasonal allergic symptoms will require any kind of systemic treatment until Day 30 of the study.
• Participant has a history of hypersensitivity to the study intervention or any of the excipients or to medicinal products with similar chemical structures.
• Participant has any other condition, which in the opinion of the Investigator precludes the participant's participation in the clinical study.

Sponsors & Collaborators

• Berlin Cures GmbH: lead

Study Sites (16)

Klinik Favoriten - Wiener Gesundheitsverbund

Vienna, 1100, Austria

Location

Klinik Floridsdorf - Wiener Gesundheitsverbund

Vienna, 1210, Austria

Location

Terveystalo Helsinki Sleep Clinic

Helsinki, Nyland and Tavastehus County, 00380, Finland

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Krankenhaus Havelhöhe

Berlin, 14089, Germany

Location

Hospital General Universitario de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospitalario Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital General de Málaga

Málaga, 29010, Spain

Location

University Hospital Virgen Del Rocio S.L.

Seville, 41013, Spain

Location

Stadtspital Zurich Waid

Zurich, 8037, Switzerland

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Axel Mescheder, Dr.

  CMO Berlin Cures GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, parallel group, placebo controlled, multicentric

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 20, 2023
• Study Start: June 16, 2023
• Primary Completion: June 26, 2024
• Study Completion: September 4, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

FI (1); CH (1); DE (8); AU (2); ES (4)