A Two-stage Randomized, Placebo-controlled, Double-blind, Phase 2a Study to Characterize the Safety and Pharmacokinetics of FBR-002 in Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Adverse events of FBR-002
研究概览
简要总结
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 dysgeusia, anosmia, fever, headache and cough to dyspnea and severe respiratory failure and even death. In order to obtain its pathogenic activity, the SARS-CoV-2 relies on its spike protein to enter the cells of the infected patient. This infection leads to a variable severity spectrum, with the majority of forms of mild entity (upper respiratory tract infection or lower respiratory tract without respiratory failure or insufficiency of other organs) despite the presence of a considerable share of severe infections in need hospitalization in sub-intensive or intensive area (up to 6% of cases) with invasive and non-invasive respiratory support. Approximately 14% of patients have experienced severe disease and 5% have been critically ill.
In the context of global pandemic, Fab'entech is currently developing polyclonal F(ab')2 equine fragments directed against the SARS-CoV-2 spike protein. Indeed, as virus entry within the cell requires this protein, Fab'entech proposes a way to block this event, neutralizing viral replication, and therefore inhibiting pathogenic activity of the virus.
The objective of this two-stage randomized, placebo-controlled, double blind, phase 2a study is to characterize the safety and pharmacokinetics of FBR-002 in patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Written informed consent provided by the patient or by a legal representative
- •Biologically confirmed SARS-CoV-2 infection ≤ 10 days before screening
- •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
- •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
- •Patient admitted to hospital for COVID-19, but outside of the Intensive Care Unit
- •Patient requiring low-flow O2 supplementation ≤ 6L/min by mask or nasal prongs at screening
- •The score of 5 on the WHO 11-point Clinical Progression Scale at screening
排除标准
- •Score ≥ 6 on the WHO 11-point Clinical Progression Scale at screening
- •Respiration rate > 30 breaths/min in adults under low-flow (⩽ 6 L/min) oxygen
- •Liver failure of stage 3 according to the Child-Pugh classification
- •Severe renal failure (≥ grade 3 according to KDIGO classification)
- •Treatment with anti-SARS-CoV-2 immunoglobulins or any blood-derived products in the last 90 days
- •Any anti-SARS-CoV-2 vaccine injection performed less than 21 days before screening
- •Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
- •Known allergy or hypersensitivity or intolerance to study product components
- •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
- •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
- •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
- •Septic shock
研究组 & 干预措施
Treatment Arm
FBR-002 at 4.3 EU/kg on D1 and D3 or FBR-002 at 5.7 EU/kg on D1 and D3
干预措施: FBR-002 (Drug)
Placebo Arm
Two administrations of placebo at D1 and D3
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events of FBR-002
时间窗: Day 1 to Day 14
The rate of treatment-emergent adverse events (serious and non-serious) of FBR-002 in the two groups of treated patients and vs. placebo over 14 days
次要结局
- Pharmacokinetics of FBR-002(Day 1 to Day 14)
- Efficacy of FBR-002(Day 8)
- Biomarkers(Day 1 to Day 14)
- Viral load(From Day 1 to Day 14)