EUCTR2021-002390-25-GR进行中（未招募）1 期
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 need of supplemental oxygen and at risk of vere outcome
Fab'entech0 个研究点目标入组 30 人开始时间: 2021年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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