COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002390-25/GR

Fab'entech - Head of Research and Development

Cecile.Herbreteau-Delale@fabentech.com

2021-12-01

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

I1. Male or female ≥ 18 years : - ≥ 70 years of age without any risk factor - or < 70 years of age and the presence of at least one of the following risk factors: - Arterial hypertension under treatment (all stages) - Obesity (Body mass index [BMI] ≥30 kg/m²) or severe obesity (BMI of ≥40 kg/m²) -Diabetes (all types) - Any history of heart conditions disease (such as heart failure, coronary artery disease, cardiomyopathies or hypertension) - Stroke or cerebrovascular disease history - Chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension - Malignancies (solid tumors or blood malignancies) that are progressive or were diagnosed less than 5 years ago - Immunocompromised state (this includes patients who are suffering from primary immunodeficiencies, patients under treatment with corticosteroids either oral or parenteral, patients receiving active chemotherapy, patients on biological treatment or treatment with JAK inhibitors) - Solid organ or blood stem cell transplant - Down syndrome - Known HIV infection - Liver failure of stage 1 and 2 based on the Child-Pugh classification - Renal failure (grade 1 and 2 according to KDIGO classification) - Haemoglobin blood disorders (like Thalassemia, Sickle Cell Disease…) - Dementia or other neurological conditions - Absence of anti-SARS-CoV2 IgM or IgG at screening I2. Written informed consent provided by the patient or by a legal representative, I3. Biologically confirmed SARS-CoV-2 infection ≤ 10 days before screening, I4. First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache, myalgias, cough, shortness of breath, fatigue, new loss of taste or smell, I5. Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection (precision for imaging: typical imaging features related to COVID-19), I6. Patient admitted to hospital for COVID-19, but outside of the Intensive Care Unit, I7. Patient requiring low-flow O2 supplement ≤ 6L/min by mask or nasal prongs at screening I8. Score of 5 on the WHO 11-point Clinical Progression Scale at screening.

E1. Score ≥ 6 on the WHO 11-point Clinical Progression Scale at screening, E2. Respiration rate > 30 breaths/min in adults under adequate oxygen, E3. Liver failure > stage 3 according to the Child-Pugh classification) E4. Severe renal failure (≥ grade 3 according to KDIGO classification) E5. Treatment with anti-SARS-CoV-2 immunoglobulins or any blood derived products in the last 90 days, E6. Any anti-SARS-CoV-2 vaccine injection performed less than 21 days before screening , E7. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study, E8. Known allergy or hypersensitivity or intolerance to study product components, E9. History of anaphylaxis during a prior administration of equine serum (i.e., anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum or anti-rabies serum) or allergic reaction due to contact or exposure to horses, E10. No parallel participation to any other investigational clinical study, E11. Patients with short life expectancy or with any severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study, E12. Septic shock.

3

Fab'entech

18

100

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

30

The primary study endpoint is to assess the safety and tolerability of two different dose regimens of FBR-002, when given to patients with COVID-19 need of oxygen supplementation at screening, until day 14. This will be measured by the comparaison of the rate of serious and non-serious treatment-emergent adverse events between patients treated with placebo and patient treated with each of the two doses of FBR-002.

Declared number of arm (5.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1152, "treatment_name": "Sars-cov-2 equine antiserum immunoglobulin (purified f(ab)2 fragment)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1152, "treatment_name": "Sars-cov-2 equine antiserum immunoglobulin (purified f(ab)2 fragment)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]