Coronavirus Infection in 2019 (COVID-19), Pneumonia, Severe Acute Respiratory Syndrome (SARS) Pneumonia
Conditions
Brief summary
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
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.
Interventions
RADIATIONLow Dose Radiation Therapy
Undergo low-dose radiation therapy
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of extubation (for intubated patients) | Screening up to 28 days after radiation therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serologic outcome - ALT | Screening up to 28 days after radiation therapy | Alanine Aminotransferase in units/L |
| Serologic outcome - AST | Screening up to 28 days after radiation therapy | Asparatate Aminotransferase in units/L |
| Serologic outcome - Troponin-I | Screening up to 28 days after radiation therapy | Troponin-I in ng/mL |
| Clinical outcome - Temperature | Screening up to 28 days after radiation therapy | Temperature in degrees (F) |
| Clinical outcome - Heart Rate | Screening up to 28 days after radiation therapy | Heart rate in beats per minutes |
| Clinical outcome - Systolic blood pressure | Screening up to 28 days after radiation therapy | Systolic blood pressure in mm Hg |
| Clinical outcome - Oxygenation | Screening up to 28 days after radiation therapy | Oxygen saturation in percentage |
| Clinical outcome - Respirations | Screening up to 28 days after radiation therapy | Respiratory rate in breaths per minute |
| Clinical outcome - FiO2 | Screening up to 28 days after radiation therapy | FI02 in percentage |
| Clinical outcome - PEEP | Screening up to 28 days after radiation therapy | Positive end expiratory pressure (PEEP) in cm H20 |
| Clinical outcome - Tidal volume | Screening up to 28 days after radiation therapy | Tidal volume in mL |
| Clinical outcome - Intubation/Extubation events | Screening up to 28 days after radiation therapy | Extubation/intubation events in percentage |
| Clinical outcome - Overall survival | Screening up to 28 days after radiation therapy | Survival in percentage |
| Radiographic outcome - Chest xray | Screening up to 28 days after radiation therapy | Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS. |
| Radiographic outcome - CT can | Screening up to 28 days after radiation therapy | CT scans with volume of consolidation measured in cubic centimeters. |
| Serologic outcome - WBC | Screening up to 28 days after radiation therapy | White blood cell count in cell count x 10\^3/mcL |
| Serologic outcome - Hgb | Screening up to 28 days after radiation therapy | Hemoglobin in gm/dL |
| Serologic outcome - Procalcitonin | Screening up to 28 days after radiation therapy | Procalcitonin in ng/mL |
| Serologic outcome - ANC | Screening up to 28 days after radiation therapy | Absolute neutrophil count in cell count x 10\^3/mcL |
| Serologic outcome - Creatine kinase | Screening up to 28 days after radiation therapy | Creatine kinase in units/L |
| Serologic outcome - Myoglobin | Screening up to 28 days after radiation therapy | Myoglobin in ng/mL |
| Serologic outcome - Albumin | Screening up to 28 days after radiation therapy | Albumin in gm/dL |
| Serologic outcome - PT/PTT | Screening up to 28 days after radiation therapy | Coagulation pathway time in seconds |
| Serologic outcome - D-Dimer | Screening up to 28 days after radiation therapy | D-Dimer in ng/mL |
| Serologic outcome - GGT | Screening up to 28 days after radiation therapy | Gamma-glutamyl transferase in units/L |
| Serologic outcome -Triglycerides | Screening up to 28 days after radiation therapy | Trygliciericdes in mg/dL |
| Serologic outcome -Ferritin | Screening up to 28 days after radiation therapy | Ferritin in ng/mL |
| Serologic outcome -Fibrinogen | Screening up to 28 days after radiation therapy | Fibrinogen in mg/dL |
| Serologic Immune markers flow cytometry | Screening up to 28 days after radiation therapy | Immune marker flow cytometry (refractive index) |
| Serologic outcome -Bilirubin | Screening up to 28 days after radiation therapy | Bilirubin in mg/dL |
| Serologic outcome - LDH | Screening up to 28 days after radiation therapy | Lactate Dehydrogenase in units/L |
| Serologic outcome - Creatinine | Screening up to 28 days after radiation therapy | Creatinine in mg/dL |
| Serologic outcome - EGFR | Screening up to 28 days after radiation therapy | Estimated Glomerular Filtration Rate in mL/min/m2 |
| Serologic outcome - BNP | Screening up to 28 days after radiation therapy | B-Natriuretic Peptid in pg/mL |
| Serologic outcome - Blood Gases pH | Screening up to 28 days after radiation therapy | pH (no unit) |
| Serologic outcome - CRP | Screening up to 28 days after radiation therapy | C-Reactive Protein in mg/L |
| Serologic outcome - Blood Gases pCO2 | Screening up to 28 days after radiation therapy | pressure of CO2 in mm Hg |
| Serologic outcome - Lactic Acid | Screening up to 28 days after radiation therapy | Lactic Acid in mmol/L |
| Serologic outcome - IL-6 | Screening up to 28 days after radiation therapy | Interleukin-6 in pg/mL |
| Serologic outcome - Potassium | Screening up to 28 days after radiation therapy | Potassium in mmol/L |
| Serologic outcome - Blood Gases pO2 | Screening up to 28 days after radiation therapy | pressure of O2 in mm Hg |
Countries
United States
Outcome results
None listed