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临床试验/NCT04374526
NCT04374526已完成2 期

Early transfusIon of COVID-19 Convalescent Plasma in Elderly COVID-19 Patients to Prevent Disease Progression.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS6 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年5月27日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
29
试验地点
6
主要终点
Rate of COVID-19 progression

研究概览

简要总结

Older age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality.

The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus.

The objective of this study are:

  • To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone
  • To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities
  • To decrease viral load
  • To raise anti-SARS-CoV-2 antibody titer in recipients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • pneumonia at CT scan
  • PaO2/FiO2 ≥300 mmHg
  • Presence of one or more comorbidities (consider the list provided in Appendix A)
  • Signed informed consent

排除标准

  • Age < 65
  • PaO2/FiO2 < 300 mmHg
  • pending cardiopulmonary arrest
  • refusal to blood product transfusions
  • Severe IgA deficiency
  • any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

结局指标

主要结局

Rate of COVID-19 progression

时间窗: days 1 to 14.

Proportion of patients without progression in severity of pulmonary disease defined as worsening of 2 points in the ordinal scale of WHO within day 14

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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