EUCTR2020-002460-31-RO进行中（未招募）1 期
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RECOMBINANT HUMAN PLASMA GELSOLIN (RHU-PGSN) ADDED TO STANDARD OF CARE FOR TREATMENT OF SUBJECTS WITH SEVERE COVID-19 PNEUMONIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •- Hospitalized with laboratory-confirmed (RT-PCR+) or highly suspected (compatible with at least bilobar lung involvement without another plausible diagnosis) COVID-19
- •- Age =18 years
- •- Weight =100 kg
- •- Within 24 hours of reaching a WHO severity score of 4-6 either:
- •- At admission
- •- While already hospitalized.
- •?Informed consent obtained from subject/next of kin/legal proxy
- •?Primary admitting diagnosis of pneumonia supported by a compatible clinical presentation with a documented infiltrate consistent with pneumonia on CXR or CT, as assessed by the admitting emergency department (ED), clinic, or ward physician or equivalent caregiver
- •?Recommended (not mandatory) guidance/discretionary criteria defining patients with pneumonia satisfying all 4 categories below:
- •- At least 2 symptoms: difficulty breathing, cough, production of purulent sputum, or chest pain
- •- At least 2 vital sign abnormalities: fever, tachycardia, or tachypnea (thresholds -- fever: oral or core temperature >100.4°F [38°C]; heart rate >100 beats/min; respiratory rate >24/min)
- •- At least one finding of other clinical signs and laboratory abnormalities: hypoxemia (O2 saturation <90%), clinical evidence of pulmonary consolidation, or leukocytosis =1.5x104 or leukopenia <4x103
- •- Chest imaging, or CT chest showing at least bilobar pulmonary infiltrates
- •?Principal Investigator (PI) to note radiologic findings in the electronic case report form (eCRF)
- •?Radiology report to be placed in the eCRF
- •?A copy of the radiograph attached to be saved for review
- •?A hyperinflammatory status (defined by increased ferritin =500 µg/L, D-dimer =1000 ng/mL, or CRP =75 mg/L)
- •?During the course of the study starting at screening and for at least 6 months after their final study treatment:
- •- Female subjects of childbearing potential must agree to use 2 medically accepted birth control methods
- •- Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner
- •- All subjects must agree not to donate sperm or eggs (ovocytes)
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- A negative RT-PCR test for COVID-19 during the evaluation of the present illness
- •- Extracorporeal membrane oxygenation (ECMO)
- •- Pregnant or lactating women
- •- Active underlying cancer treated with systemic chemotherapy or radiation therapy during the last 30 days
- •- Transplantation of hematopoietic or solid organs
- •- Chronic mechanical ventilation or dialysis
- •- Otherwise unsuitable for study participation because of chronic, severe, end-stage, and life-limiting underlying disease unrelated to COVID-19 likely to interfere with management and assessment of acute pneumonia, only comfort or limited (non-aggressive) care is to be given, or life expectancy <6 months unrelated to acute COVID infection in the opinion of the Investigator
研究者
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