Safety and pharmacokinetics of FBR-002 for the treatment of patients hospitalized with COVID-19 need of supplemental oxygen and at risk of severe outcome

Phase 1

• Conditions: COVID-19 in hospitalized patients in need of supplemental oxygen and at risk of severe outcome; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002390-25-GR
• Lead Sponsor: Fab'entech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-01
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified