EUCTR2022-002724-12-GR进行中（未招募）1 期
A phase IIb randomized, placebo-controlled, double-blind study, to evaluate the efficacy and safety of FBR-002 in participants hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome
Fab'entech0 个研究点目标入组 70 人开始时间: 2022年10月18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
- 70
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 old and = 90 years old
- •=70 years old with or without any risk factor
- •Or <70 years old and the presence of at least one of the following risk factors from the medical history:
- •oTreated arterial hypertension (all stages);
- •oObesity (Body Mass Index [BMI] = 30kg/m²) or severe obesity (BMI = 40 kg/m²);
- •oAll types of diabetes (type 1 and type 2);
- •oAny history of heart conditions disease (such as heart failure, coronary artery disease, cardiomyopathies or hypertension);
- •oStroke or cerebrovascular disease history;
- •oChronic lung diseases, including but not limited to COPD (chronic obstructive pulmonary disease), asthma (moderate to severe), interstitial
- •lung disease, cystic fibrosis and pulmonary hypertension;
- •oMalignancies: solid tumor that are progressive or treated within the year prior to participant screening/or blood malignancies that are
- •progressive or treated within the 3 years prior to participant screening in the study;
- •oImmunocompromised state (this includes participants who are suffering from primary immunodeficiencies; participants under treatment with
- •corticosteroids either oral or parenteral (at least 10 mg per day prednisone-equivalent for at least 14 days prior to randomization);
- •participants receiving active chemotherapy; participants on biological treatment or treatment with JAK inhibitors);
- •oSolid organ or blood stem cell transplant;
- •oDown syndrome;
- •oKnown HIV infection;
- •oLiver failure of stage 1 and 2 based on the Child-Pugh classification;
- •oRenal failure (grade 1, 2, 3a and 3b according to KDIGO classification);
- •oHemoglobin blood disorders (like Thalassemia, Sickle Cell Disease…);
- •oDementia or other neurological conditions;
- •oAbsence of anti-SARS-CoV2 IgM or IgG at screening;
- •I2. Participant must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provide written informed consent (provided by the participant or by a legal representative);
- •I3. Biologically confirmed SARS-CoV-2 infection = 10 days before screening (either by PCR or antigenic test);
- •I4. First onset of COVID-19 symptoms = 10 days, like fever and/or chills, headache, myalgia, 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. Participant admitted to hospital for COVID-19, but outside of the Intensive Care Unit;
- •I7. Participant 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;
- •I9. Female of childbearing potential must have a serum negative pregnancy test at screening. Male and female of childbearing potential must use a highly effective method of contraception during treatment and at least for 1 month after the last dose of study treatment;
- •I10. Participant must not be receiving therapy in a concurrent clinical trial at the time of screening and also 30 days prior to the screening and must agree not to participate in any other interventional clinical studies during their participation in this trial.
- •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 subje
排除标准
- •E1. Score <5 or =6 on the WHO 11-point Clinical Progression Scale at screening;
- •E2. Respiratory 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 4 according to KDIGO classification);
- •E5. Any anti-SARS-CoV-2 vaccine injection performed less than 21 days prior to screening;
- •E6. Known allergy or hypersensitivity or intolerance to study product components;
- •E7. History of anaphylaxis during or prior administration of equine serum (i.e anti-tetanus serum or anti-ophidic serum or anti-arachnid toxic serum or anti-rabies serum) or allergic reaction due to contact or exposure to horses;
- •E8. Participants with short life expectancy or with any severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the participant’s participation to the study;
- •E9. Septic shock ongoing at the time of screening or within the last 30 days of screening.
研究者
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