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

Pneumonia Clinical Trial

— RESCUE 1-19  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04366791
• Other study ID #: STUDY00000476
• Secondary ID: NCI-2020-02676RA
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 24, 2020
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection in 2019 (COVID-19)
• Coronavirus Infections
• COVID-19
• Pneumonia
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome (SARS) Pneumonia

Intervention

Radiation:
• Low Dose Radiation Therapy
Undergo low-dose radiation therapy

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hosptial	Atlanta	Georgia
United States	Emory University Hospital Midtown/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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