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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
Participants will be treated with two infusions of BC 007 or placebo two weeks apart, according to a double-blind design
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
...and 6 more locations
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.
Time frame: Day 30
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
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.
Proportion of participants sero-converting to negative for GPCR-AAB
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
Proportion of participants sero-converting to negative for GPCR-AAB
Time frame: at Days 3, 15, 17, 30, 60 and Day 90 post first infusion of study intervention.
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