ISRCTN33578935进行中（未招募）2 期
Rationale and investigational study for the treatment of COVID-19 with severe viral pneumonia with isolated, placental, mesenchymal stem cell exosomes
Kimera Labs0 个研究点目标入组 64 人开始时间: 2020年6月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. COVID-19 patients requiring invasive mechanical ventilation for respiratory failure due to pneumonia
- •2. Requiring treatment with vasopressors
- •3. Requiring artificial ventilation and PaO2/FiO2 < 300 mmHg
排除标准
- •1. Recent administration of hydroxychloroquine, chloroquine, or steroids
- •2. Recent administration of tocilizumab (IL-6 antibody)
- •3. Hospital acquired (HAP)-, Health Care acquired (HCAP)- or Ventilator associated-pneumonia (VAP)
- •4. Pneumonia exclusively of bacterial or fungal origin* bacterial pneumonia co-infected with viruses and/or other microorganisms may be entered into the study. *Due to the short time window (up to 18 hours) between fulfillment of severity criteria (ie initiation of invasive mechanical ventilation or vasopressors administration, whichever comes first) and the start of the first dose of study treatment, patients with a pneumonia of suspected viral origin by any established standard diagnostic method routinely applied at the study site (eg oral swap antigen test, rt-PCR) can be entered into the study (confirmation of viral origin must be obtained afterwards)
- •5. Known or suspected Pneumocystis jirovecii (formerly known as Pneumocystis carinii) pneumonia
- •6. Aspiration pneumonia
- •7. Known active tuberculosis
- •8. A history of post-obstructive pneumonia
- •9. Cystic fibrosis
- •10. Any chronic lung disease requiring oxygen therapy at home
- •11. Presence of infection in another organ location caused by same pathogen (eg
- •12. Pneumococcal meningitis in the context of pneumococcal pneumonia)
- •13. Expected to have rapidly fatal disease within 72 hours after randomization
- •14. Inability to maintain a mean arterial pressure 50 mmHg prior to Screening despite the presence of vasopressors and intravenous fluids
- •15. Not expected to survive for 3 months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases
- •16. A history of malignancy in the 5 years prior to screening, except for successfully surgically treated non-melanoma skin malignancies
- •17. Known primary immunodeficiency disorder or with HIV infection and acquired immune deficiency syndrome (AIDS) with CD4 count <200 cells/mm3 or not receiving highly active antiretroviral therapy (HAART) for HIV
- •18. Receiving immunosuppressant therapy (including chronic treatment with anti-TNFa) or on chronic high doses of steroids (single administration of 2 mg/kg body weight or 20 mg/day of prednisone or equivalent for 2 weeks)
- •19. Granulocyotopenia, not due to sepsis, as evidenced by leukocyte absolute neutrophil count <500 per µL>21 days prior to onset of pneumonia symptoms
- •20. Received stem cell therapy, or allogeneic transplantation (organ or bone marrow transplant) within the past 6 months
- •21. Receiving treatment with a biological agent (eg antibodies, cells), immunotherapy or plasma exchange treatment within the last 8 weeks
- •22. A known liver function impairment associated with liver cirrhosis (Child Pugh C) or known esophageal varices
- •23. Hospitalized within the previous 15 days
- •24. Conditions resulting in a New York Heart Association or Canadian Cardiovascular Society Class IV functional status
- •25. End-stage neuromuscular disorders (eg motor neuron diseases, myasthenia gravis, etc) or cerebral disorders that impair weaning
- •26. Patients with quadriplegi
研究者
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