Phase 2b/3 Trial to Evaluate the Safety and Efficacy of Plasma Transfusion From Convalescent Patients With SARS-CoV-2 Infection on Severity and Mortality of COVID-19 in Hospitalized Patients.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 410
- 试验地点
- 2
- 主要终点
- Severity and death
研究概览
简要总结
This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.
详细描述
A total of 410 patients with COVID 19 who fulfill inclusion criteria will be invited to receive:
Human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 hours or Normal saline solution in a similar plasma bag. Both products will be covered in an identical material to avoid identification of the infused product.
Primary endpoint:
Improvement on the 8 point WHO scale over 28 days.
Secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Encasement of plasma and saline bags with an identical material will be done in Blood bank
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age and older.
- •Confirmed SARS-CoV2 infection
- •Hospitalized for COVID 19
- •Severe disease or risk for severe disease
- •Informed consent from patient or responsible person.
排除标准
- •History of allergic reactions to blood products
- •SOFA scale >12 points
- •Absolute contraindication for administration of plasma
- •Participation in other blinded clinical trial
- •Projected life expectancy less than 3 months
- •Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.
结局指标
主要结局
Severity and death
时间窗: 28 days
Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.
Adverse events that require study treatment interruption
时间窗: During the 28 day of follow up
Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention that require interruption of study treatment. Including but not limited to: Severe allergic reactions (rash and fever), transfusion-associated lung injury (TRALI), transfusion-associated circulatory overload (TACO), and other severe unexpected events
次要结局
- Time to clinical improvement(28 days)
- Disease progression 1(28 days)
- Number of days with fever(28 days)
- Adverse events attributed to the study intervention(28 days)
- Severity and death(Days 1, 3, 5, 7, 12, 14, and 21.)
- Antibodies against SARS-CoV-2(Days 0, 3, 7, 14, 21, 28)
- Disease progression 2(Days 7,14, 21, 28)
- Time on mechanical ventilation(28 days)
研究者
Juan G. Sierra Madero
Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran