COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05279352

Cécile Herbreteau-Delale

cecile.herbreteau-delale@fabentech.com

2022-03-15

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: i1. male or female ≥ 18 years greater than or equal to 70 years of age with or without any risk factor or less than 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) heart conditions (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 janus kinase (jak) inhibitors) solid organ or blood stem cell transplant down syndrome known human immunodeficiency virus (hiv) infection liver disease of stage 1 and 2 based on the child-pugh classification (appendix c) hemoglobin blood disorders (thalassemia, sickle cell disease, etc) renal disease (grade 1 and 2 according to kidney disease improving global outcomes (kdigo) classification) (see appendix d) 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, the new loss of taste or smell i5. findings in chest-x-ray or 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 supplementation ≤ 6l/min by mask or nasal prongs at screening i8. the 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 low-flow (⩽ 6 l/min) oxygen e3. liver failure of 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. participation in any other interventional study with an investigational product in the last 30 days or within 5 half-lives of receiving the investigational product 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

2

Fab'entech

18

100

Greece

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

30

Adverse events of FBR-002

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 2400, "treatment_name": "Fbr-002", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]