search
Back to results

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

Primary Purpose

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

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low Dose Radiation Therapy
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University Hospital Midtown/Winship Cancer Institute
  • Emory Saint Joseph's Hosptial

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (low-dose radiation therapy)

Arm Description

Patients undergo 1 fraction of low-dose radiation therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2020
Last Updated
March 14, 2022
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04366791
Brief Title
Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
PI does not plan on putting any new patients on study. All patients completed this trial.
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Coronavirus Infection in 2019 (COVID-19), Severe Acute Respiratory Syndrome (SARS) Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Khan, MD, PhD
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Saint Joseph's Hosptial
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
34653525
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs