Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- Clinical deterioration or death
研究概览
简要总结
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world.
There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people.
It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.
详细描述
Objetive:
Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the clinical progresion and mortality of hospitalized COVID-19 patients.
Metodology:
Fase II, controled clinical trial, double blinded, compared with placebo, with paralel groups, and one to one asignation. It will be included patients between 18 and 79 years old, hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis. It will be excluded those who have indication for management in Intensive Care Unit, have any condition that seriusly affect their survival, pregnant whomen or breast feeding, those who have an advanced hearth failure, HIV infected, those who have a bacterial or fungal uncontroled infection, those who require permanent immunosupresive therapy or have had an organ trasplant, those who have no possibility to sign the informed consent format or are involved in another clinical trial with drugs or interventions.
It will vinculate 30 patients randomly assigned, by centralized electronic assignation sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human umbilical cord or to placebo group.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe COVID-
- •Infection confirmed by PCR test.
- •Hospitalized in general room (respiratory isolation area).
排除标准
- •Shock or multiorgan disfunction that require continous vital signs monitorization
- •Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
- •Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
- •Pregnant women or breast feeding.
- •Advanced hearth failure.
- •VIH/AIDS.
- •Bacterial or fungical uncontroled infection.
- •Permanente use of immunosupresants or have had received an organ trasnplanted in the past six months.
- •Imposibility to sign the informent consent format.
- •Patients involved in another clinical trial with drugs or interventions.
结局指标
主要结局
Clinical deterioration or death
时间窗: 4 weeks
Change in two or more degrees in the NEWS scale
次要结局
未报告次要终点