Efficacy and Safety of Convalescent Plasma vs Human Immunoglobulin for the Treatment of COVID-19 Pneumonia: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Mean hospitalization time
研究概览
简要总结
Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives.
Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection.
Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin.
Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.
详细描述
I. Background:
In late December 2019, the health authorities of the Popular Republic of China reported several cases of pneumonia of unknown origin in Wuhan City, Hubei Province, China. On December 31, 2019, the Chinese Center for Disease Control and Prevention began etiological and epidemiological research on this disease. Three samples of bronchoalveolar lavage were taken from patients from the Jinyintan hospital in Wuhan and through various processes they came to identify a new coronavirus that they initially called on January 7, 2020 as: 2019-nCoV. On January 2020, the World Health Organization (WHO) made the first recommendations on the epidemiological surveillance of this new coronavirus.
On January 22, 2020, the first session of the Emergencies Committee was convened by WHO in Geneva, Switzerland and on January 30 a Public Health Emergency of International Importance (ESPII) was declared.
On February 11, the International Committee on Virus Taxonomy named this new coronavirus as SARS-CoV-2 and responds to "Severe Acute Respiratory Syndrome Coronavirus 2 "(Severe Acute Respiratory Syndrome CoronaVirus 2), the WHO proposes that same day to call the disease caused by SARS-CoV-2 as COVID-19.
The first case reported in Latin America was in Brazil on February 26 and on the 28th of the same month, Mexico communicates its first confirmed case of the new coronavirus in a 35-year-old patient from a trip to Italy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria:
- •Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
- •Requiring invasive mechanical ventilation.
排除标准
- •Patients with a viral infection other than COVID-19
研究组 & 干预措施
Severe pneumonia due to COVID-19
Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria:
- Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
- Requiring invasive mechanical ventilation.
干预措施: Plasma from COVID-19 convalescent patient (Drug)
Severe pnemonia due to COVID-19
Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria:
- Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (FiO2 = 100%)]
- Requiring invasive mechanical ventilation.
干预措施: Human immunoglobulin (Drug)
结局指标
主要结局
Mean hospitalization time
时间窗: Through study completion, an average of 3 months
Mean days from admission as a suspected case of COVID with hospitalization criteria until discharge
Rate of severe ARDS
时间窗: Through study completion, an average of 3 months
Rate of patients with evolution to severe ARDS (PaO2/FiO2 \< 100)
Mean Oxigenation index evolution
时间窗: Through study completion, an average of 3 months
Mean of delta of oxigenation index (PaO2/FiO2)
Rate and time to dead
时间窗: Through study completion, an average of 3 months
Rate of Dead caused by COVID-19 related complications and time to dead caused by COVID-19 complication
Mean time with invasive mechanical ventilation
时间窗: Through study completion, an average of 3 months
Mean time with invasive mechanical ventilation
次要结局
- Time to Viral PCR Negativization(Through study completion, an average of 3 months.)