Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19

Study Overview
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Brief Summary
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This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.

Detailed Description
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PRIMARY OBJECTIVE: I. To compare treatment of COVID-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy OUTLINE: Patients undergo 1 fraction of low-dose radiation therapy. After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Official Title
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The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19

Conditions
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Pneumonia, Coronavirus Infection in 2019 (COVID-19), Severe Acute Respiratory Syndrome (SARS) Pneumonia

Intervention / Treatment
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* Radiation: Low Dose Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have had a positive test confirming the diagnosis of COVID-19 Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment) Have visible consolidations/ground glass opacities on chest x-ray or computed tomography Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy. Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions 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 Exclusion Criteria: No use of disallowed medications 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications Pregnant and/or planned to be pregnant within in next 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (low-dose radiation therapy)<br>Patients undergo 1 fraction of low-dose radiation therapy. | Radiation: Low Dose Radiation Therapy<br>* Undergo low-dose radiation therapy<br>* Other names: Low Dose Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of extubation (for intubated patients) | The rate will be reported, along with a two-sided 95% exact binomial confidence interval, using the Clopper-Pearson method. The observed extubation rate will be compared to the null rate of 20% using a two-sided binomial test. Statistical significance is assessed at the 0.05 level. | Screening up to 28 days after radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome - Temperature | Temperature in degrees (F) | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Heart Rate | Heart rate in beats per minutes | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Systolic blood pressure | Systolic blood pressure in mm Hg | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Oxygenation | Oxygen saturation in percentage | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Respirations | Respiratory rate in breaths per minute | Screening up to 28 days after radiation therapy | 
| Clinical outcome - FiO2 | FI02 in percentage | Screening up to 28 days after radiation therapy | 
| Clinical outcome - PEEP | Positive end expiratory pressure (PEEP) in cm H20 | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Tidal volume | Tidal volume in mL | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Intubation/Extubation events | Extubation/intubation events in percentage | Screening up to 28 days after radiation therapy | 
| Clinical outcome - Overall survival | Survival in percentage | Screening up to 28 days after radiation therapy | 
| Radiographic outcome - Chest xray | Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS. | Screening up to 28 days after radiation therapy | 
| Radiographic outcome - CT can | CT scans with volume of consolidation measured in cubic centimeters. | Screening up to 28 days after radiation therapy | 
| Serologic outcome - WBC | White blood cell count in cell count x 10^3/mcL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Hgb | Hemoglobin in gm/dL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Procalcitonin | Procalcitonin in ng/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - ANC | Absolute neutrophil count in cell count x 10^3/mcL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Creatine kinase | Creatine kinase in units/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Myoglobin | Myoglobin in ng/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Albumin | Albumin in gm/dL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - PT/PTT | Coagulation pathway time in seconds | Screening up to 28 days after radiation therapy | 
| Serologic outcome - D-Dimer | D-Dimer in ng/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - GGT | Gamma-glutamyl transferase in units/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome -Triglycerides | Trygliciericdes in mg/dL | Screening up to 28 days after radiation therapy | 
| Serologic outcome -Ferritin | Ferritin in ng/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome -Fibrinogen | Fibrinogen in mg/dL | Screening up to 28 days after radiation therapy | 
| Serologic Immune markers flow cytometry | Immune marker flow cytometry (refractive index) | Screening up to 28 days after radiation therapy | 
| Serologic outcome -Bilirubin | Bilirubin in mg/dL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - LDH | Lactate Dehydrogenase in units/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Creatinine | Creatinine in mg/dL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - EGFR | Estimated Glomerular Filtration Rate in mL/min/m2 | Screening up to 28 days after radiation therapy | 
| Serologic outcome - CRP | C-Reactive Protein in mg/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome - ALT | Alanine Aminotransferase in units/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome - AST | Asparatate Aminotransferase in units/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Troponin-I | Troponin-I in ng/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - BNP | B-Natriuretic Peptid in pg/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Blood Gases pH | pH (no unit) | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Blood Gases pO2 | pressure of O2 in mm Hg | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Blood Gases pCO2 | pressure of CO2 in mm Hg | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Lactic Acid | Lactic Acid in mmol/L | Screening up to 28 days after radiation therapy | 
| Serologic outcome - IL-6 | Interleukin-6 in pg/mL | Screening up to 28 days after radiation therapy | 
| Serologic outcome - Potassium | Potassium in mmol/L | Screening up to 28 days after radiation therapy |