Study of the Efficacy of Reinforcing of the Standard Therapy in COVID-19 Patients With Repeated Transfusion of Immune Plasma From COVID-19 Convalescents vs Exclusive Standard Therapy in Hospitalized COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.
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
- None
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
- •Ability to understand the HIP and sign the study IC
- •male or female =/> 18 years
- •Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample.
- •Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days.
- •Presence of pneumonia on chest X-ray and / or SatO2 <94% aa.
- •Sequential Organ Failure Assessment (SOFA) score ≤
- •Accept the condition of complying with the procedures established in the protocol.
排除标准
- •Patients with a previous history of allergic transfusion reaction.
- •Lactating or pregnant women and a positive pregnancy test.
- •Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit.
- •Patients who are at the time of study, participating in another clinical trial.
- •Patients who haven't completed all study procedures.
结局指标
主要结局
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II
时间窗: Day 14
The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.
次要结局
- Anti-SARS-CoV-2 S IgG Serum Titer(At inclusion, Day 21)
- Time of Hospitalization(Day 21)
- Time to Negativization of RT-PCR(Day 21)
- Diastolic Blood Pressure(At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21)
- Systolic Blood Pressure(At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21)
- Temperature(At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21)
- Absolute Lymphocytes(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Fibrinogen Level(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Cardiac Frequency(At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21)
- Respiratory Frequency(At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21)
- Neutrophils(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Glomerular Filtration Rate Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Troponin I Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Oxygen Saturation(At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21)
- Hemoglobin(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Leucocytes(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Activated Partial Thromboplastin Time(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Procalcitonin Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Lactate Dehydrogenase (LDH) Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Percentage of Patients Requiring Admission to Intensive Care Units.(Day 21)
- Fragment D-dimer Assessment(At inclusion, Day 3, Day 7, Day 14)
- C-reactive Protein Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Interleukin-6 Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Ferritin Blood Assessment(At inclusion, Day 3, Day 7, Day 14, Day 21)
- Mortality Rate at 15 Days(Day 15)
- Mortality Rate at 30 Days(Day 30)
研究者
Maria Arrizabalaga Asenjo
Principal Investigator
Hospital Son Llatzer