EUCTR2020-001953-36-ES进行中（未招募）1 期
A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin® plus Standard Medical Treatment (SMT) versus SMT alone in Hospitalized Subjects with COVID-19.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1. Hospitalized male or female patient = 18 years of age at time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (= 48 hours) of hospital admission.
- •2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
- •3. COVID-19 illness (symptoms) of any duration, including both of the following:
- •a) Radiographic infiltrates by imaging (chest X-Ray, CT scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with SpO2 <94% on room air
- •b) Any One of the following related to COVID-19: i. Ferritin > 400ng/mL, ii. LDH > 300 U/L, iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 mg/L
- •4. Subject provides informed consent (ICF) prior to initiation of any study procedures.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Patients requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2 = 150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air]).
- •2. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
- •3. The subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known Selective IgA Deficiency with anti-IgA antibodies.
- •4. A medical condition in which the infusion of additional fluid is contraindicated (e.g., decompensated congestive heart failure or renal failure with fluid overload).
- •5. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
- •6. Known alpha-1 antitrypsin deficiency for which the patient is already receiving alpha1-proteinase inhibitor augmentation therapy.
- •7. Women who are pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.
- •8. Patients for whom there is limitation of therapeutic effort such as Do not resuscitate” status Note: If the decision is made not to apply treatments or therapeutic procedures that will provide little benefit for the suffering or agony the patient is experiencing, such a patient would not be appropriate for participation in this study and should be excluded.
- •9. Currently participating in another interventional clinical trial with investigational medical product or device
- •10. Patients previously requiring long-term oxygen therapy (home oxygen therapy)
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