long Covid MedDRA version: 25.1 Level: LLT Classification code 10087832 Term: COVID-19 rebound System Organ Class: 100000004862
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 during the intervention period, and at least 90 days from the time of receiving the last dose of the study intervention. 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 has a previous positive SARS-CoV-2 test result (PCR test or documented rapid antigen test) not older than 12 months at screening and reported long COVID symptoms starting no later than 12 weeks after the first positive test and might have had a symptom-free interval between the acute phase of infection and the occurrence of long COVID symptoms as defined by the WHO. 7. Participant is screened positive for GPCR-AAB activity. 8. Participant has not been intubated or received ECMO support during their acute COVID-19 infection. 9. Participant screens positive for fatigue (FACIT-F score =65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1. Any history or evidence of any clinically significant cardiovascular (specifically tachycardia including Postural Orthostatic Tachycardia Syndrome. 2. Any history of gastrointestinal, endocrinologic (Type 1 diabetes,), haematologic, hepatic, immunologic, metabolic (specifically gout), urologic, pulmonary (asthma), neurologic, dermatologic, renal and/or other major disease or malignancy, as judged by the Investigator before SARS-CoV-2 infection. 3. 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. 4. Any history of any other chronic neurological, or psychological disease such as, but not limited to, chronic fatigue syndrome, fibromyalgia, lupus, Sjogren’s syndrome; or history of allergic reactions, judged to be clinically significant by the Investigator. 5. Participant has a history of hypersensitivity to the study intervention or any of the excipients or to medicinal products with similar chemical structures. 6. Participant has any other condition, which in the opinion of the Investigator precludes the participant’s participation in the clinical study. 7. Participant shows clinically significant abnormalities in clinical chemistry or haematology at screening, as judged by the Investigator. 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, or whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s). 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. Participant has alcohol addiction or history of alcohol addiction. 14. Participant has drug addiction or history of drug addiction. 15. 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. 16. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the last 5 years. 17. Participant has had comparable and prolonged symptoms after other viral infections (e.g.,?after Epstein-Barr virus infection, influenza, infectious mononucleosis). 18. Previous diagnosis of sleep apnoea. 19. Current use of medications with psychoactive properties that have a deleterious effect on cognition.
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 Quality of life;Primary end point(s): Mean change from baseline in score on FACIT-F scale 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 Days 3, 15, 17, 30, 90, 180 and Day 360 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) -Day 180 (all assessments) -Day 270 (all assessments) -Day 360 (all assessments) Results will be reported as: -Mean change from baseline in score on FACIT-F scale. -Proportion of subjects with an increase from baseline in FACIT-F score of at least 6 -Proportion of subjects with an increase from baseline in FACIT-F score of at least 3. -Proportion of subjects with a FACIT-F 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 Days 3, 15, 17, 30, 60, 90, 180, 270 and 360. Mean change from baseline in hours slept during the night as measured by the sleep item as part of the COA symptom diary score sheet, reported on Day 15, Day 30, Day 60, Day 90, Day 180, Day 270 and Day 360. Mean change from baseline in hours slept during the night as measured by the sleep item as part of the level of severity of sleep during the day (insomnia/hypersomnia assessment), reported on Day 15, Day 30, Day 60, Day 90, Day 180, Day 270 and Day 360. Mean change in baseline on the quality of sleep reported on the quality of sleep item on Day 15, Day 30, Day 60, Day 90, Day 180, Day 270 and Day 360. 6MWT at Day 1, Day 3, Day 15, Day 17, Day 30, Day 60, Day 90, Day 180, Day 270, and Day 360. Evaluation of the safety of study intervention at scr | — |
Countries
Austria, Finland, Germany, Spain, Switzerland
Contacts
Public ContactClinical Trial Department
Berlin Cures GmbH
Outcome results
None listed