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
Overview
- Phase
- Phase 2
- Intervention
- BC 007 or matching placebo
- Conditions
- Long Covid
- Sponsor
- Berlin Cures GmbH
- Enrollment
- 119
- Locations
- 16
- Primary Endpoint
- Mean change from baseline in score on FACIT-FS scale at Day 30.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
1350mg BC 007 solution for infusion for 75-minutes intravenous infusion
Intervention: BC 007 or matching placebo
0.9% NaCl solution for infusion for 75-minutes intravenous infusion
Intervention: BC 007 or matching placebo
1900mg BC 007 solution for infusion for 105-minutes intravenous infusion
Intervention: BC 007 or matching placebo
0.9% NaCl solution for infusion for 105-minutes intravenous infusion
Intervention: BC 007 or matching placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.)