long Covid MedDRA version: 25.1 Level: LLT Classification code 10087832 Term: COVID-19 rebound System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Berlin Cures GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 =65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 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 a major gastrointestinal, endocrinologic (e.g., insulin-dependent diabetes), cardiovascular, hematologic, hepatic, immunologic, metabolic (specifically gout), urologic, pulmonary (e.g., allergic or intrinsic asthma), neurologic, dermatologic, renal and/or other major disease, as judged by the Investigator. 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 longCOVID. • Mild hypertension (2× upper limit of normal (ULN). • International normalized ratio (INR) >1.2. 8. Female participant is pregnant and/or breast feeding. 9. Participant participated in a previous clinical study (within 30 days or 5 half-lives of the investigational drug, 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. 10. Participant is an employee of the Sponsor, or contract research organization (CRO) conducting the study. 11. 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). 12. Participant with an estimated glomerular filtration rate <60 mL/min/1,73 m². 13. Participan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy of BC 007 (double dose 1350 mg and double dose 1900 mg) with placebo based on fatigue symptomatic severity scale in long COVID participants. ;Secondary Objective: To compare GPCRAAB neutralizing effect of BC 007 1350 mg with that of placebo. To compare GPCRAAB neutralizing effect of BC 007 1900 mg with that of placebo. To compare GPCR-AAB neutralizing effect of BC 007 1350 mg with that of BC 007 1900 mg To compare efficacy of BC 007 (double dose, 1350 mg or 1900 mg) with placebo including patient outcome measures, and symptoms in participants with long COVID. To compare efficacy of BC 007 (double dose, 1350 mg or 1900 mg) with placebo based on symptoms (as assessed by COA symptom diary) in participants with long COVID To compare efficacy of BC 007 (double dose, 1350 mg or 1900 mg) with placebo based on performance levels in participants with long COVID To compare safety and tolerability of BC 007 (double dose, 1350 mg or 1900 mg) with respective placebo after two infusions separated by a 14-day interval (treatment phase) To assess the viral load in faeces To assess blood coagulation Blood sedimentation rate Quality of life ;Primary end point(s): Mean change from baseline in score on FACIT-FS at Day 30. ;Timepoint(s) of evaluation of this end point: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of participants sero-converting to negative for GPCR-AAB at Day 3, Day 15, Day 17, Day 30, Day 60, and Day 90 post first infusion of study intervention. The below outcome measures will be assessed at the following times: -Day 1 (baseline, all assessments) -Day 3 (COA symptom diary) -Day 15 (pre-dose, all assessments) -Day 17 (COA symptom diary) -Day 30 (all assessments; FACIT-F is primary end point) -Day 60 (all assessments) -Day 90 (all assessments) Results will be reported as: -Mean change from baseline in score on FACIT-FS. -Proportion of subjects with an increase from baseline in FACIT-FS score of at least 6 -Proportion of subjects with an increase from baseline in FACIT-FS score of at least 3. -Proportion of subjects with a FACIT-FS score greater than 34 -Mean change from baseline in cognitive impairment as measured by PDQ assessing attention/focus, retrospective and prospective memory, planning and organization ability. -Mean/median change from baseline in symptoms score calculated as sum of symptom scores/number of symptoms scored on Day 3, Day 15, Day 17, Day 30, Day 60, and Day 90. -Mean change from baseline in hours slept in the past 24 hours as measured by the sleep item as part of the COA symptom diary score sheet, reported on Day 15, Day 30, Day 60, and Day 90. -Mean change from baseline for the tiredness whilst being awake reported on the tiredness item as part of the COA symptom diary score sheet on Day 15, Day 30, Day 60, and Day 90. -Mean change in baseline on the quality of sleep reported on the quality of sleep item on Day 15, Day 30, Day 60, and Day 90. -6 MWT at Day 1, Day 3, Day 15, Day 17, Day 30, Day 60, and Day 90. -Evaluation of the safety of study intervention at Screening visit, during administration of study intervention, and during outpatient periods until the end of the treatment phase assessed at Day 3 and Day 15, the follow up period assessed at Day 17, Day 30, Day 60, and Day 90. - | — |
Countries
Austria, Finland, Germany, Spain, Switzerland
Contacts
Public ContactClinical Trial Department
Berlin Cures GmbH
Outcome results
None listed