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临床试验/NCT04634370
NCT04634370Unknown1 期

Fase I Clinical Trial on Natural Killer Cells for COVID-19

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年1月2日最近更新:
适应症

试验速览

阶段
1 期
入组人数
24
试验地点
2
主要终点
Improvement in Liao's score (2020)

研究概览

简要总结

Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available.

This study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with COVID-19.

详细描述

In March 2020, the World Health Organization secreted COVID-19 as a pandemic. Although most infected individuals can develop effective immunity, the population at risk (elderly, obese and individual with comorbidities) develop a rapid and frequently fatal disease, with severe acute respiratory syndrome, cytokine storm and coagulopathies; for those who recover, severe pulmonary sequels are frequently observed. We propose a phase I clinical trial to test safety and feasibility of NK cells adoptive immunotherapy for COVID-19. Natural Killer cells are innate granular lymphocytes able to rapidly recognize and kill, without previous exposition, altered cells; it is widely recognized as immune effectors specialized in lysing virus infected cells releasing antigens and activating cytokines to antigen presenting cells and, by doing so, stimulating effective adaptive immunity. We hypothesize that the early infusion of highly activated NK cells will activate adaptive immune effectors preventing the severe clinical evolution of COVID-19 infection. Adoptive NK cell immunotherapy for severe virus infections is innovative. Our proposition is in line with the Brazilian Public Health system purposes, which is to offer secure and effective therapies for all COVID-19 infected individuals. Upon proving NK cell immunotherapy effectiveness for serious virus infections, we can evolve to test this strategy for common viruses that cause epidemics and endemics such as the ones caused by Dengue, Zika, Chikungunya, C and B hepatitis and HIV.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR);
  • The patient or legal donor agrees to participate in the study and signs the informed consent;
  • Patients with white or yellow criteria according to the score proposed by Liao et al (2020).

排除标准

  • Patient with pregnancy, are planning to become pregnant or breastfeeding;
  • Patients with malignant blood-borne diseases such as HIV or syphilis;
  • Not consenting for clinical trial;
  • Patients with other than white or yellow criteria according to the score proposed by Liao et al (2020).

结局指标

主要结局

Improvement in Liao's score (2020)

时间窗: 60 days

Improvement in Liao's score (2020)

Hospital stay

时间窗: 60 days

days of the patients in hospital

Changes on inflammatory C-reactive protein

时间窗: 60 days

To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)

Oxygenation index (PaO2/FiO2)

时间窗: 60 days

Evaluation of functional respiratory changes: PaO2 / FiO2 ratio

Overall survival

时间窗: 30 days

Assessment of Overall survival at 30 days post intervention

Radiological improvement

时间窗: 60 days

Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19

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 (2)

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