COVID-19 和呼吸功能不全患者的低剂量全肺放射治疗 (VENTED)

实验性的：Radiation Arm

Each subject will receive a dose of whole lung radiation. A second optional dose of 80 cGy may be delivered if no improvement after 3-10 days.

辐射：放射治疗

患者将以一种简化的方式接受双侧肺部 80 cGy 的单剂量治疗，以便可以在一个疗程中快速设计和递送。 该协议中没有使用特定的正常组织约束。

其他名称：

• 直线加速器
• X光片

Mortality Rate of Subjects Treated With Whole Lung Low-dose Radiation.

Number of subjects who expire from the date of radiation up to 1 month post radiation dose. The date will be collected if subject expires

To Compare Total Hospital Stay and Length of Hospital Stay After Post Radiation Dose

number of days hospitalized before and after radiation

Evaluate Total and Post-ULD-WLRT ICU Length of Stay

Number of days in ICU after receiving radiation therapy

Number of Days Alive After RT in Days

Number of days subject survives Ultra Low Dose-Whole Lung Radiation Therapy, including hospital days and post discharge from hospital until lost to follow-up

Days of Supplemental Oxygen Therapy

To evaluate total supplemental oxygen therapy

Ventilator-free Days

number of days without mechanical ventilation

Oxygenation Index Post RT

Oxygenation index until extubated, for up to 47 days. Oxygenation Index (OI) in medicine (OI = FiO2 x MAP x100/ PaO2) assesses severe lung injury, with higher numbers meaning worse function. This is expressed as a fraction, with no units and is not a percentage

A normal Oxygenation Index (OI) measures the severity of respiratory failure. The ratio is for a healthy peron is 25 and lower. Oxygenation Index values of 25-40 indicate high mortality,

Definitions: Mean Airway Pressure (MAP); FiO2 (Fraction of Inspired Oxygen) is the concentration or percentage of oxygen a patient breathes; PaO2 (Partial pressure of oxygen) is a measurement from an Arterial Blood Gas (ABG) test that shows the pressure of oxygen dissolved in your arterial blood

Differences Between Ground Glass Opacities (GGO), Lung Infiltrates and Opacification Percentage

Quantitate post-ULD-WLRT the baseline and Day 7, 14, and 28 CT chest findings ( total number of GGO, lung infiltrates and opacification) and the percentage of each chest finding (GGO, lung infiltrates and opacification) found in a CT scan image.

Viral Titers at Days 0, 1 7, 14 and 28 Post RT

Evaluate SARS-CoV2 viral titers at baseline and post Ultra Low Dose-Whole Lung Radiation Therapy (ULD-WLRT) at Day 0, 1, 7, 14, and 28

Tolerability of Regimen

Establish safety and tolerability using number of days of survival

Molecular Markers

Molecular biomarker levels in COVID-19 patients upfront as well as after treatment with Ultra Low Dose-Whole Lung Radiation Therapy (ULD-WLRT) such as levels or inflammatory and DNA damage markers).

Baseline Molecular Biomarkers

Determine baseline molecular biomarkers that predict response to Ultra Low Dose-Whole Lung Radiation Therapy (ULD-WLRT) in COVID-19 patients.

Molecular Biomarker Level

Determine molecular biomarkers that change over the treatment course, correlating with disease status and resolution.

Evaluate Treatment Plan Evaluation Using CBCT Images

Retrospectively evaluate rapidly planned treatment using volumetric treatment plan evaluation based on Cone Beam CT (CBCT)

Compare Imaging Data

comparison of raw diagnostic and CBCT imaging data for machine-learning assessment of longitudinal progression in patients with COVID-19

Compare Raw Imaging Data for Diagnosis

Collect raw imaging data for further evaluation of the potential for identification of COVID-19 in diagnostic scans