Safety and Pharmacokinetics of FBR-002 for the Treatment of Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome

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 riskfactors:
• 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, andpulmonary hypertension
• Malignancies (solid tumors or blood malignancies) that are progressive or werediagnosed less than 5 years ago
• Immunocompromised state (this includes patients who are suffering from primaryimmunodeficiencies; patients under treatment with corticosteroids either oral orparenteral; patients receiving active chemotherapy; patients on biologicaltreatment 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 (AppendixC)
• Hemoglobin blood disorders (Thalassemia, Sickle Cell Disease, etc)
• Renal disease (grade 1 and 2 according to Kidney Disease Improving GlobalOutcomes (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 lowerrespiratory tract infection* * precision for imaging: typical imaging features relatedto 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 atscreening
• I8. The score of 5 on the WHO 11-point Clinical Progression Scale at screening

Exclusion Criteria:

• 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 inthe 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 aurine 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 productin 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'sparticipation in the study
• E12. Septic shock