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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02676 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RAD5002-20 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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PI does not plan on putting any new patients on study. All patients completed this trial.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (low-dose radiation therapy) | Experimental | Patients undergo 1 fraction of low-dose radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Radiation Therapy | Radiation | Undergo low-dose radiation therapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Khan, MD, PhD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown/Winship Cancer Institute | Atlanta | Georgia | 30308 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34653525 | Derived | Hess CB, Eng TY, Nasti TH, Dhere VR, Kleber TJ, Switchenko JM, Weinberg BD, Rouphael N, Tian S, Rudra S, Taverna LS, Daisson AP, Ahmed R, Khan MK. Whole-lung low-dose radiation therapy (LD-RT) for non-intubated oxygen-dependent patients with COVID-19-related pneumonia receiving dexamethasone and/or remdesevir. Radiother Oncol. 2021 Dec;165:20-31. doi: 10.1016/j.radonc.2021.10.003. Epub 2021 Oct 13. |
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No
Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2020 |
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| 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 |
| Emory Saint Joseph's Hosptial |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Jun 12, 2020 |
| Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2023 | May 23, 2023 | 7 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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