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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366791
Recruitment Status : Terminated (PI does not plan on putting any new patients on study. All patients completed this trial.)
First Posted : April 29, 2020
Last Update Posted : March 29, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mohammad K. Khan, Emory University

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE April 29, 2020
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE April 24, 2020
Actual Primary Completion Date March 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
Rate of extubation (for intubated patients) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Clinical outcome - Temperature [ Time Frame: Screening up to 28 days after radiation therapy ]
    Temperature in degrees (F)
  • Clinical outcome - Heart Rate [ Time Frame: Screening up to 28 days after radiation therapy ]
    Heart rate in beats per minutes
  • Clinical outcome - Systolic blood pressure [ Time Frame: Screening up to 28 days after radiation therapy ]
    Systolic blood pressure in mm Hg
  • Clinical outcome - Oxygenation [ Time Frame: Screening up to 28 days after radiation therapy ]
    Oxygen saturation in percentage
  • Clinical outcome - Respirations [ Time Frame: Screening up to 28 days after radiation therapy ]
    Respiratory rate in breaths per minute
  • Clinical outcome - FiO2 [ Time Frame: Screening up to 28 days after radiation therapy ]
    FI02 in percentage
  • Clinical outcome - PEEP [ Time Frame: Screening up to 28 days after radiation therapy ]
    Positive end expiratory pressure (PEEP) in cm H20
  • Clinical outcome - Tidal volume [ Time Frame: Screening up to 28 days after radiation therapy ]
    Tidal volume in mL
  • Clinical outcome - Intubation/Extubation events [ Time Frame: Screening up to 28 days after radiation therapy ]
    Extubation/intubation events in percentage
  • Clinical outcome - Overall survival [ Time Frame: Screening up to 28 days after radiation therapy ]
    Survival in percentage
  • Radiographic outcome - Chest xray [ Time Frame: 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 [ Time Frame: Screening up to 28 days after radiation therapy ]
    CT scans with volume of consolidation measured in cubic centimeters.
  • Serologic outcome - WBC [ Time Frame: Screening up to 28 days after radiation therapy ]
    White blood cell count in cell count x 10^3/mcL
  • Serologic outcome - Hgb [ Time Frame: Screening up to 28 days after radiation therapy ]
    Hemoglobin in gm/dL
  • Serologic outcome - Procalcitonin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Procalcitonin in ng/mL
  • Serologic outcome - ANC [ Time Frame: Screening up to 28 days after radiation therapy ]
    Absolute neutrophil count in cell count x 10^3/mcL
  • Serologic outcome - Creatine kinase [ Time Frame: Screening up to 28 days after radiation therapy ]
    Creatine kinase in units/L
  • Serologic outcome - Myoglobin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Myoglobin in ng/mL
  • Serologic outcome - Albumin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Albumin in gm/dL
  • Serologic outcome - PT/PTT [ Time Frame: Screening up to 28 days after radiation therapy ]
    Coagulation pathway time in seconds
  • Serologic outcome - D-Dimer [ Time Frame: Screening up to 28 days after radiation therapy ]
    D-Dimer in ng/mL
  • Serologic outcome - GGT [ Time Frame: Screening up to 28 days after radiation therapy ]
    Gamma-glutamyl transferase in units/L
  • Serologic outcome -Triglycerides [ Time Frame: Screening up to 28 days after radiation therapy ]
    Trygliciericdes in mg/dL
  • Serologic outcome -Ferritin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Ferritin in ng/mL
  • Serologic outcome -Fibrinogen [ Time Frame: Screening up to 28 days after radiation therapy ]
    Fibrinogen in mg/dL
  • Serologic Immune markers flow cytometry [ Time Frame: Screening up to 28 days after radiation therapy ]
    Immune marker flow cytometry (refractive index)
  • Serologic outcome -Bilirubin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Bilirubin in mg/dL
  • Serologic outcome - LDH [ Time Frame: Screening up to 28 days after radiation therapy ]
    Lactate Dehydrogenase in units/L
  • Serologic outcome - Creatinine [ Time Frame: Screening up to 28 days after radiation therapy ]
    Creatinine in mg/dL
  • Serologic outcome - EGFR [ Time Frame: Screening up to 28 days after radiation therapy ]
    Estimated Glomerular Filtration Rate in mL/min/m2
  • Serologic outcome - CRP [ Time Frame: Screening up to 28 days after radiation therapy ]
    C-Reactive Protein in mg/L
  • Serologic outcome - ALT [ Time Frame: Screening up to 28 days after radiation therapy ]
    Alanine Aminotransferase in units/L
  • Serologic outcome - AST [ Time Frame: Screening up to 28 days after radiation therapy ]
    Asparatate Aminotransferase in units/L
  • Serologic outcome - Troponin-I [ Time Frame: Screening up to 28 days after radiation therapy ]
    Troponin-I in ng/mL
  • Serologic outcome - BNP [ Time Frame: Screening up to 28 days after radiation therapy ]
    B-Natriuretic Peptid in pg/mL
  • Serologic outcome - Blood Gases pH [ Time Frame: Screening up to 28 days after radiation therapy ]
    pH (no unit)
  • Serologic outcome - Blood Gases pO2 [ Time Frame: Screening up to 28 days after radiation therapy ]
    pressure of O2 in mm Hg
  • Serologic outcome - Blood Gases pCO2 [ Time Frame: Screening up to 28 days after radiation therapy ]
    pressure of CO2 in mm Hg
  • Serologic outcome - Lactic Acid [ Time Frame: Screening up to 28 days after radiation therapy ]
    Lactic Acid in mmol/L
  • Serologic outcome - IL-6 [ Time Frame: Screening up to 28 days after radiation therapy ]
    Interleukin-6 in pg/mL
  • Serologic outcome - Potassium [ Time Frame: Screening up to 28 days after radiation therapy ]
    Potassium in mmol/L
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
Official Title  ICMJE The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pneumonia
  • Coronavirus Infection in 2019 (COVID-19)
  • Severe Acute Respiratory Syndrome (SARS) Pneumonia
Intervention  ICMJE Radiation: Low Dose Radiation Therapy
Undergo low-dose radiation therapy
Other Name: Low Dose Radiation
Study Arms  ICMJE Experimental: Supportive care (low-dose radiation therapy)
Patients undergo 1 fraction of low-dose radiation therapy.
Intervention: Radiation: Low Dose Radiation Therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 14, 2022)
47
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
10
Actual Study Completion Date  ICMJE March 11, 2022
Actual Primary Completion Date March 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04366791
Other Study ID Numbers  ICMJE STUDY00000476
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.

Responsible Party Mohammad K. Khan, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mohammad Khan, MD, PhD Emory University Hospital/Winship Cancer Institute
PRS Account Emory University
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP