COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000167-69/DE

AiCuris Anti-Infective Cures AG - Head of Regulatory Affairs

silvia.riffel-friedrich@Aicuris.com

2021-03-03

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed. Subject has given written consent to participation in the trial and has delivered the signed Informed Consent Form to the site/Investigator prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive) for SARS-CoV-2 non-vaccinated or not fully vaccinated, and between 18 and 65 years (inclusive) when SARS-CoV-2 fully vaccinated. Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction (qRT-PCR) testing from a throat swab on Day -1 (with ≥10^5 viral copies for SARS-CoV-2 non-vaccinated subjects or not fully vaccinated, qRT-PCR positive without threshold for SARS-CoV-2 fully vaccinated subjects), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. SARS-CoV-2 non-vaccinated subjects or not fully vaccinated subjects only: First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. As vomiting or diarrhoea may reduce the efficacy of oral contraceptives, women of childbearing potential should use other methods or avoid heterosexual intercourse during the timeframe of potentially reduced efficacy. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg

A subject will not be eligible for inclusion if any of the following criteria apply: Safety concerns 1. A known hypersensitivity to constituents of the IMP, including polygeline, patients with a history of allergies (severe drug allergies or severe insect bite allergy), hypersensitivities including asthma, chronic obstructive pulmonary disease (COPD), phaeochromocytomas, mastocytosis or mast cell activation disorders, patients with a history of anaphylactic/anaphylactoid reactions or existing anaphylactoid reactions and patients receiving histamine releasing agents. 2. Known history or current evidence of hypertension, diabetes mellitus, cardiovascular disease, cancer, chronic lung and acute or chronic kidney diseases. 3. Current evidence of being a smoker (defined as having smoked within 3 months prior to dosing) 4. History or current evidence of autoimmune diseases such as psoriasis, multiple sclerosis, systemic lupus erythematosus, etc 5. On treatment with interferons or other immunomodulatory/ immunosuppressive agents 6. Any vaccinations (including SARS-CoV-2) within 14 days prior to screening or planned during the trial 7. Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables on Day -1 8. Clinically relevant acute or chronic infections including HIV (exception SARS-CoV-2) 9. Moderate, Severe or Critical SARS-CoV-2 infection (see Section 6.6.2.2), including with Acute Respiratory Distress Syndrome (ARDS), treated in an intensive care unit (ICU) or on mechanical ventilation. 10. Moderate or severe cough and/or moderate (defined as ≥38.5°C) or severe fever. 11. Blood lymphocyte count below the normal range or lactate dehydrogenase (LDH) above the normal range 12. Clinically relevant elevation of serum inflammatory markers (eg, CRP, procalcitonin) 13. Subject is participating in other investigational therapy clinical trial(s) 14. Subject is lactating or breastfeeding. 15. Not able to communicate meaningfully with the Investigator and site staff. 16. Lack of ability or willingness to give informed consent. 17. Anticipated non-availability for trial visits/procedures. 18. Vulnerable subjects (eg, persons kept in detention or persons who have a dependent relationship to the Sponsor or Investigator).

2

AiCuris Anti-Infective Cures AG

18

55

South Africa;Germany

Mild disease at enrollment

1: Mild disease at enrollment

60

Safety and tolerability endpoints • The following safety variables will be recorded at regular intervals during the study: • Nature, frequency, duration, severity, and causality of adverse events (AEs) and serious adverse events (SAEs) • Clinical laboratory, tests (hematology, clinical chemistry and urinalysis) • Vital signs (supine blood pressure [BP], pulse rate, oxygen saturation (SpO2), body temperature and respiratory rate [RR]) • Standard 12-lead Electrocardiogram (ECG) • Concomitant medication assessments • Physical examinations • Local tolerance

Declared number of arm (3.0) differs from found arms (2.0)

Phase 1/Phase 2

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