EUCTR2020-001936-86-DE进行中（未招募）1 期
A prospective, randomized, open label Phase 2 clinical trial to evaluate superiority of anti-SARS-CoV-2 convalescent plasma versus standard-of-care in hospitalized patients with mild COVID-19 - Convalescent Plasma in Mild Covid-19 for Early Treatment
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
- 340
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
- •Patients infected with SARS-CoV-2 virus and
- •1.age = 18 years and = 75 years
- •2.fulfills RKI case definition including a positive verification of a SARS-CoV-2 infection from any specimen (e.g. respiratory, blood, other bodily fluid)*
- •* confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
- •3.mild disease defined by the following criteria:
- •- Hospitalized (score 3 or 4 of WHO R&D Blueprint ordinal scale for clinical improvement)
- •4.signed written informed consent and willingness to comply with treatment and follow-up procedures
- •? women without childbearing potential defined as follows:
- •at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy,
- •hysterectomy or uterine agenesis,
- •= 50 years and in postmenopausal state > 1 year, or
- •< 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening;
- •? women with childbearing potential:
- •who are practicing true abstinence from sexual intercourse (periodic abstinence and withdrawal are not acceptable),
- •who have sexual relationship with female partners only and/or with sterile male partners, or
- •who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical 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 subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months
- •2.In the opinion of the clinical team, progression to death is imminent and inevitable with-in the next 24 hours, irrespective of the provision of treatment
- •3.Chronic obstructive lung disease (COPD), stage 4
- •4.Lung fibrosis with UIP pattern in CT und severe emphysema
- •5.Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to = 30%
- •6.Liver cirrhosis Child C
- •7.Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN).
- •8.End stage renal failure requiring hemodialysis
- •9.Organ or bone marrow transplant in the three month prior to screening
- •10.History of adverse reactions to plasma proteins
- •11.Known deficiency of immunoglobulin A
- •12.Pregnancy and breastfeeding women
- •13.Volume overload until sufficiently treated
- •14.Pulmonary edema
- •15.Body mass index (BMI) > 40 kg/m2
- •16.Participation in another clinical trial, especially for treatment of COVID-19
- •17.Allergy or other contraindication to one of the investigational products
- •18.Previous treatment with SARS-CoV-2 convalescent plasma
研究者
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