Status:
UNKNOWN
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
Lead Sponsor:
Fab'entech
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the coronavirus associated with COVID-19 (Coronavirus Disease 2019), invading the respiratory tract, and leading to symptoms from dysgeu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05279352
Start Date
March 21 2022
End Date
July 15 2022
Last Update
April 4 2022
Active Locations (6)
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1
University General Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
2
"Sotiria" General Hospital of Chest Diseases of Athens
Athens, Greece, 115 27
3
University General Hospital of Athens ATTIKON
Athens, Greece, 12462
4
University General Hospital of Patras
Pátrai, Greece, 26504