PACTR202009769021840尚未招募2 期
A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) in the treatment of severe Covid 19 pneumonia patients on (or requiring) mechanical ventilatory support. COVID-19
Agakhan University Hospital Nairobi0 个研究点目标入组 20 人开始时间: 2020年8月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •a.Be age 18 or over
- •b.Have had a positive rtPCR test confirming the diagnosis of COVID-19 from nasopharyngeal swab, Sputum or lower respiratory tract sample
- •c.Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrolment)
- •d.Documented pO2 < 94% while on ambient air on admission, and requires supplemental oxygen to maintain pO2 = 94%.
- •1.Cohort 1: currently not on mechanical ventilation but would need mechanical ventilation if condition worsens (pre-Vent)
- •2.Cohort 2: currently on mechanical ventilation for = 5 days (on-Vent)
- •e.Have visible consolidations/ground glass opacities on chest x-ray or computed tomography consisted with Covid 19 pneumonia.
- •f.The patient, according to the treating physician, has received medical treatment considered best practice as per the institution’s guidelines, and does not show improvement
- •g.Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions.
- •h.Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
排除标准
- •a.Pre-existing lung comorbidity such as severe COPD, severe uncontrolled asthma or heart failure or concomitant active systemic infection.
- •b.Pre-existing dependency on supplemental oxygen prior to diagnosis of Covid 19 pneumonia
- •c.Patients on mechanical ventilation requiring 100% FIO2 and > 8mm PEEP to maintain pO2 > 94% will not be eligible
- •d.Unwilling or unable to following protocol procedures
- •e.Pregnant and/or planned to be pregnant within in next 6 months
- •f.Hemodynamic and Ventilatory instability precluding transfer to Radiation Oncology department
研究者
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