EUCTR2020-005305-54-DE进行中（未招募）1 期
Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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. Participants must be = 18 years of age at the time of signing the informed consent.
- •2. Confirmed positive by PCR or antigen test for SARS-CoV-2 with sample collection = 10 days prior to the day of randomization. PCR is the preferred method; however other tests for SARS-CoV-2 are allowed if authorized for use in the country.
- •3. Covid-19 illness of any duration of symptoms.
- •4. Participant capable of understanding the study and giving informed consent. Participant capable of signing and dating the written ICF. Participant must understand and agree to comply with planned study procedures for the duration of the study. The study visits beyond Day 28 will be optional and require a separate consent.
- •5. Hospitalized for Covid-19 illness for = 5 days with mild to moderate Covid-19 symptoms including:
- •- Mild: Symptoms of Covid-19 including fever, rhinorrhea, mild cough, sore throat, headache, muscle pain, malaise but not requiring supplemental oxygen
- •- Moderate: Lower respiratory symptoms: shortness of breath (SOB) or signs of pneumonia or lung infiltrates based on X-ray or computed tomography (CT) scan < 50% present
- •And Meets the criteria for:
- •- Category 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise) OR
- •- Category 5 - Hospitalized, requiring supplemental oxygen, OR
- •- Category 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices per 8-point ordinal scale.
- •6. Adequate organ function
- •7. Eligible participants of child-bearing age (male or female) must agree to use adequate contraception for a total of 6 weeks after study treatment administration.
- •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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening (and randomization) or anticipated impending need for mechanical ventilation.
- •2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
- •3. Any uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit (ICU).
- •4. Participants with malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of Screening.
- •5. Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited to) biologics such as anti-CD20, anti-TNF, anti-IL6, anti-IL6 receptor; alkylating agents (e.g., cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use equivalent to prednisone >10 mg/day, during preceding 2 months.
- •Note: Steroids for treatment of Covid-19 are acceptable.
- •6. Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered less than 24 hours prior to randomization. Participants must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study.
- •7. Patients who are participating in other clinical trials including participants in an extended access program.
- •8. Active deep vein thrombosis or pulmonary embolism as confirmed by the investigator within last 6 months.
- •9. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours of admission as confirmed by the investigator.
- •10. Any active uncontrolled co-morbid disease that might interfere with study conduct or interpretation of findings.
- •11. Known to be positive for HIV or positive test for chronic HBV infection (defined as positive hepatitis B surface antigen [HbsAg]) or positive test for hepatitis C antibody.
- •12. Pregnancy or breast feeding.
- •13. Persons under legal protection or currently incarcerated.
研究者
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