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

Phase 1

Terminated

• Conditions: Coronavirus Infection in 2019 (COVID-19); Pneumonia; Severe Acute Respiratory Syndrome (SARS) Pneumonia
• Interventions: Radiation: Low Dose Radiation Therapy

• Registration Number: NCT04366791
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-24
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-29
• Status Verified: 2022-03
• Primary Completion: 2022-03-11
• Study Completion: 2022-03-11
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (low-dose radiation therapy)	Low Dose Radiation Therapy	Patients undergo 1 fraction of low-dose radiation therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical outcome - FiO2	Screening up to 28 days after radiation therapy	FI02 in percentage
Serologic outcome - Procalcitonin	Screening up to 28 days after radiation therapy	Procalcitonin in ng/mL
Clinical outcome - Overall survival	Screening up to 28 days after radiation therapy	Survival in percentage
Clinical outcome - Intubation/Extubation events	Screening up to 28 days after radiation therapy	Extubation/intubation events in percentage
Radiographic outcome - CT can	Screening up to 28 days after radiation therapy	CT scans with volume of consolidation measured in cubic centimeters.
Serologic outcome - Hgb	Screening up to 28 days after radiation therapy	Hemoglobin in gm/dL
Serologic outcome - ANC	Screening up to 28 days after radiation therapy	Absolute neutrophil count in cell count x 10\^3/mcL
Serologic outcome - LDH	Screening up to 28 days after radiation therapy	Lactate Dehydrogenase in units/L
Clinical outcome - Oxygenation	Screening up to 28 days after radiation therapy	Oxygen saturation in percentage
Serologic outcome - PT/PTT	Screening up to 28 days after radiation therapy	Coagulation pathway time in seconds
Serologic outcome -Triglycerides	Screening up to 28 days after radiation therapy	Trygliciericdes in mg/dL
Serologic outcome - Potassium	Screening up to 28 days after radiation therapy	Potassium in mmol/L
Clinical outcome - Systolic blood pressure	Screening up to 28 days after radiation therapy	Systolic blood pressure in mm Hg
Clinical outcome - Temperature	Screening up to 28 days after radiation therapy	Temperature in degrees (F)
Clinical outcome - Respirations	Screening up to 28 days after radiation therapy	Respiratory rate in breaths per minute
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 -Fibrinogen	Screening up to 28 days after radiation therapy	Fibrinogen in mg/dL
Serologic outcome -Bilirubin	Screening up to 28 days after radiation therapy	Bilirubin in mg/dL
Serologic outcome - EGFR	Screening up to 28 days after radiation therapy	Estimated Glomerular Filtration Rate in mL/min/m2
Serologic outcome - AST	Screening up to 28 days after radiation therapy	Asparatate Aminotransferase in units/L
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)
Clinical outcome - Heart Rate	Screening up to 28 days after radiation therapy	Heart rate in beats per minutes
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
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.
Serologic outcome - WBC	Screening up to 28 days after radiation therapy	White blood cell count in cell count x 10\^3/mcL
Serologic outcome - D-Dimer	Screening up to 28 days after radiation therapy	D-Dimer in ng/mL
Serologic outcome - CRP	Screening up to 28 days after radiation therapy	C-Reactive Protein in mg/L
Serologic outcome - ALT	Screening up to 28 days after radiation therapy	Alanine Aminotransferase in units/L
Serologic outcome - GGT	Screening up to 28 days after radiation therapy	Gamma-glutamyl transferase in units/L
Serologic outcome -Ferritin	Screening up to 28 days after radiation therapy	Ferritin in ng/mL
Serologic Immune markers flow cytometry	Screening up to 28 days after radiation therapy	Immune marker flow cytometry (refractive index)
Serologic outcome - Creatinine	Screening up to 28 days after radiation therapy	Creatinine in mg/dL
Serologic outcome - Troponin-I	Screening up to 28 days after radiation therapy	Troponin-I in ng/mL
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 - Blood Gases pO2	Screening up to 28 days after radiation therapy	pressure of O2 in mm Hg
Serologic outcome - Blood Gases pCO2	Screening up to 28 days after radiation therapy	pressure of CO2 in mm Hg

Trial Locations

Locations (2)

Emory University Hospital Midtown/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory Saint Joseph's Hosptial; 🇺🇸 Atlanta, Georgia, United States