To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID

Inclusion Criteria:

Participant is eligible to be included in the study only if all the following criteria apply:

1. The participant provides written informed consent prior to any clinicalstudy-specific procedures.

2. The participant is a male or female, ≥18 years of age, at the time of signing theinformed consent form.

3. All male and female participants of childbearing potential must be willing to useeffective 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 chainreaction [PCR] test) at screening.

6. The participant provides a documented positive SARS-CoV-2 test result (reversetranscriptase [RT]-PCR or rapid antigen test) at Screening. For participants withlong COVID symptoms who cannot provide certified evidence, a positive antibody testfor nucleocapsid protein IgG must demonstrate a history of SARS CoV 2 infection;this test can be performed as part of the Screening procedure. The participantreports persistence or new onset of symptoms after a SARS-CoV-2 infection, withthese symptoms lasting for at least 2 consecutive months (being persistent,recurrent, or of varying severity within that period) with no other explanation, asdefined by WHO, and not being present prior to COVID-19 infection.

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 acuteCOVID-19 infection.

9. Participant screens positive for fatigue (FACIT-FS score <35) and presents with atleast one additional symptom from the symptom score sheet (COA) which has persistedfor more than 12 weeks.

10. Participant is not on any permanent medication(s) to treat chronic diseases thatexisted prior to COVID 19 infection. Exceptions are clinically stable conditions,which do not affect the study assessments and may be allowed as judged by theInvestigator after discussion with the medical monitor. Clinically unstable isdefined as a diagnosis or condition requiring changes in disease management within 2months prior to start of Screening and includes ongoing workup of an undiagnosedillness that could lead to a new diagnosis or condition. Concomitant treatment maybe permitted, if

• A treatment (type and dose) remained unchanged within the 2 months before thestart 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.

11. Participant reports that his/her activity level was not impaired prior to acuteCOVID-19 infection.

Exclusion Criteria:

Participant is excluded from the study if any of the following criteria apply:

1. Postural Orthostatic Tachycardia Syndrome existing prior to the initial SARS CoV 2infection leading to long COVID, as per medical history. History or evidence of anyclinically significant cardiovascular disease.

2. 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 majordisease , as judged by the Investigator before SARS-CoV-2 infection. Otherclinically stable conditions, which do not affect the study assessments may beallowed as judged by the Investigator after discussion with the medical monitor. Possible allowed diseases are (if stable and well-controlled) include but are notlimited to:

• Respiratory disorders (e.g., asthma-like) that first appear with long COVID.

• Mild hypertension (<160 mmHg systolic, <100 mmHg diastolic) without known organor vessel damage.

• Non-insulin-dependent diabetes mellitus without known organ or vessel damage.

• Glaucoma.

• Hypercholesterolemia/hypertriglyceridemia.

• Hypothyreosis

3. Participants with history of major active or chronic unstable psychiatric illness (e.g., but not limited to, depression, bipolar disorder, obsessive compulsivedisorder, schizophrenia) within the previous year.

4. Any history of any other chronic neurological, or psychological disease such as, butnot limited to, chronic fatigue syndrome, fibromyalgia, lupus, Sjogren's syndrome. Any history or presence of relevant allergic reactions (e.g., requiring hospitalstay, intravenous [i.v.] treatment or treatment with systemic steroids). Aparticipant will not be included if it is likely that seasonal allergic symptomswill require any kind of systemic treatment until Day 30 of the study.

5. Participant has a history of hypersensitivity to the study intervention or any ofthe excipients or to medicinal products with similar chemical structures.

6. Participant has any other condition, which in the opinion of the Investigatorprecludes the participant's participation in the clinical study.

7. Participant shows clinically significant abnormalities in clinical chemistry orhaematology 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 5half-lives of the investigational drug, or whichever is longer prior to start ofScreening) or concomitant participation in another clinical study withinvestigational medicinal product(s) or device(s),or participant previouslyparticipated 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 closerelative of the Investigator, dependent person (e.g., employee or student of theinvestigational 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 islikely to invalidate informed consent or limit the ability of the participant tocomply with the protocol requirements.

16. History of malignancy of any organ system (other than localized basal cell carcinomaof 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 deleteriouseffect on cognition.