Long CovidPhase 2BLOCNCT05911009
To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID
A Phase 2 study of Long Covid, run by Berlin Cures GmbH at 16 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 16 Jun 2023to 4 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- Antihypertensives (β-blockers are NOT allowed)
- Lipid lowering agents.
- Antidiabetics (insulin is NOT allowed)
- Thyroid hormone replacement.
- Topical treatments.
- Low dose acetylsalicylic acid (up to 100 mg/day).
- Ivabradine.
- Participant reports that his/her activity level was not impaired prior to acute COVID-19 infection.
Who cannot join
- 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.
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- 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.
- Participant shows clinically significant abnormalities in clinical chemistry or haematology at screening, as judged by the Investigator.
- Female participant is pregnant and/or breast feeding.
- Participant participated in a previous clinical study (within 30 days or 5 half-lives of the investigational drug, or whichever is longer prior to start of Screening) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s),or participant previously participated in this study and received study intervention.
- Participant is an employee of the Sponsor, or contract research organization (CRO) conducting the study.
- Participant has a close affiliation with the investigational site, e.g., a close relative of the Investigator, dependent person (e.g., employee or student of the investigational site).
- Participant with an estimated glomerular filtration rate <60 mL/min/1,73 m².
- Participant has alcohol addiction or history of alcohol addiction.
- Participant has drug addiction or history of drug addiction.
- Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent or limit the ability of the participant to comply with the protocol requirements.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the last 5 years.
- Participant has had comparable and prolonged symptoms after other viral infections (e.g., after Epstein-Barr virus infection, influenza, infectious mononucleosis).
- Previous diagnosis of sleep apnoea.
- Current use of medications with psychoactive properties that have a deleterious effect on cognition.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Germany8 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Krankenhaus Havelhöhe
Berlin, 14089
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum Jena
Jena, Thuringia, 07747
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Spain4 sites
Hospital General Universitario de Alicante
Alicante, Valencia, 03010
Hospitalario Universitario Quironsalud Madrid
Madrid, 28223
Hospital General de Málaga
Málaga, 29010
University Hospital Virgen Del Rocio S.L.
Seville, 41013
Austria2 sites
Klinik Favoriten - Wiener Gesundheitsverbund
Vienna, 1100
Klinik Floridsdorf - Wiener Gesundheitsverbund
Vienna, 1210
Finland1 site
Terveystalo Helsinki Sleep Clinic
Helsinki, Nyland and Tavastehus County, 00380
About this study
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
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).
Read more
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
- Being tested
- BC 007 or matching placebo
- Keywords
- Long Covid, Autoantibodies, Post-acute COVID-19 syndrome, BC 007, PASC
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC 007 or matching placeboDrug
Participants will be treated with two infusions of BC 007 or placebo two weeks apart, according to a double-blind design
| Study group | Role | What they receive |
|---|---|---|
| 1350mg BC 007 solution for infusion for 75-minutes intravenous infusion | Experimental | Not described Receives: Drug: BC 007 or matching placebo |
| 0.9% NaCl solution for infusion for 75-minutes intravenous infusion | Placebo comparator | Not described Receives: Drug: BC 007 or matching placebo |
| 1900mg BC 007 solution for infusion for 105-minutes intravenous infusion | Experimental | Not described Receives: Drug: BC 007 or matching placebo |
| 0.9% NaCl solution for infusion for 105-minutes intravenous infusion | Placebo comparator | Not described Receives: Drug: BC 007 or matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (3)
To compare GPCR AAB neutralizing effect of BC 007 1350 mg with that of placebo.
Proportion of participants sero-converting to negative for GPCR-AAB
Measured: 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.
Proportion of participants sero-converting to negative for GPCR-AAB
Measured: 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
Proportion of participants sero-converting to negative for GPCR-AAB
Measured: at Days 3, 15, 17, 30, 60 and Day 90 post first infusion of study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start16 Jun 2023
- Primary completion26 Jun 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long CovidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, parallel group, placebo controlled, multicentric
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin Cures GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Mescheder, Dr., Study director, CMO Berlin Cures GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911009
- Sponsor's protocol ID
- SBC007C401
- Other IDs
- 2022-003452-14
- Acronym
- BLOC
- Status last verified
- Nov 2024
- First submitted
- 15 Jun 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05911009
- Acronym / sponsor ID
- BLOC / SBC007C401
- Conditions
- Long Covid
- Keywords
- Long Covid, Autoantibodies, Post-acute COVID-19 syndrome, BC 007, PASC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Berlin Cures GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- double-blind, randomized, parallel group, placebo controlled, multicentric
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BC 007 or matching placeboParticipants will be treated with two infusions of BC 007 or placebo two weeks apart, according to a double-blind design | Drug | 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 |
Primary outcome
Mean change from baseline in score on FACIT-FS scale at Day 30.
Time frame: 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.
3 secondary outcomes
To compare GPCR AAB neutralizing effect of BC 007 1350 mg with that of placebo.
Time frame: 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.
Time frame: 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
Time frame: at Days 3, 15, 17, 30, 60 and Day 90 post first infusion of study intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Mescheder, Dr. study director
CMO Berlin Cures GmbH
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Long Covid, run by Berlin Cures GmbH at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Spain, Austria, Finland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in score on FACIT-FS scale at Day 30. (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.