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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366791
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Clayton Hess, 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.

Condition or disease Intervention/treatment Phase
Pneumonia Coronavirus Infection in 2019 (COVID-19) Severe Acute Respiratory Syndrome (SARS) Pneumonia Radiation: Low Dose Radiation Therapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The RESCUE 1-19 Trial: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : October 23, 2020
Estimated Study Completion Date : October 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Supportive care (low-dose radiation therapy)
Patients undergo 1 fraction of low-dose radiation therapy.
Radiation: Low Dose Radiation Therapy
Undergo low-dose radiation therapy
Other Name: Low Dose Radiation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical outcome - Temperature [ Time Frame: Screening up to 28 days after radiation therapy ]
    Temperature in degrees (F)

  2. Clinical outcome - Heart Rate [ Time Frame: Screening up to 28 days after radiation therapy ]
    Heart rate in beats per minutes

  3. Clinical outcome - Systolic blood pressure [ Time Frame: Screening up to 28 days after radiation therapy ]
    Systolic blood pressure in mm Hg

  4. Clinical outcome - Oxygenation [ Time Frame: Screening up to 28 days after radiation therapy ]
    Oxygen saturation in percentage

  5. Clinical outcome - Respirations [ Time Frame: Screening up to 28 days after radiation therapy ]
    Respiratory rate in breaths per minute

  6. Clinical outcome - FiO2 [ Time Frame: Screening up to 28 days after radiation therapy ]
    FI02 in percentage

  7. Clinical outcome - PEEP [ Time Frame: Screening up to 28 days after radiation therapy ]
    Positive end expiratory pressure (PEEP) in cm H20

  8. Clinical outcome - Tidal volume [ Time Frame: Screening up to 28 days after radiation therapy ]
    Tidal volume in mL

  9. Clinical outcome - Intubation/Extubation events [ Time Frame: Screening up to 28 days after radiation therapy ]
    Extubation/intubation events in percentage

  10. Clinical outcome - Overall survival [ Time Frame: Screening up to 28 days after radiation therapy ]
    Survival in percentage

  11. 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.

  12. Radiographic outcome - CT can [ Time Frame: Screening up to 28 days after radiation therapy ]
    CT scans with volume of consolidation measured in cubic centimeters.

  13. Serologic outcome - WBC [ Time Frame: Screening up to 28 days after radiation therapy ]
    White blood cell count in cell count x 10^3/mcL

  14. Serologic outcome - Hgb [ Time Frame: Screening up to 28 days after radiation therapy ]
    Hemoglobin in gm/dL

  15. Serologic outcome - Procalcitonin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Procalcitonin in ng/mL

  16. Serologic outcome - ANC [ Time Frame: Screening up to 28 days after radiation therapy ]
    Absolute neutrophil count in cell count x 10^3/mcL

  17. Serologic outcome - Creatine kinase [ Time Frame: Screening up to 28 days after radiation therapy ]
    Creatine kinase in units/L

  18. Serologic outcome - Myoglobin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Myoglobin in ng/mL

  19. Serologic outcome - Albumin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Albumin in gm/dL

  20. Serologic outcome - PT/PTT [ Time Frame: Screening up to 28 days after radiation therapy ]
    Coagulation pathway time in seconds

  21. Serologic outcome - D-Dimer [ Time Frame: Screening up to 28 days after radiation therapy ]
    D-Dimer in ng/mL

  22. Serologic outcome - GGT [ Time Frame: Screening up to 28 days after radiation therapy ]
    Gamma-glutamyl transferase in units/L

  23. Serologic outcome -Triglycerides [ Time Frame: Screening up to 28 days after radiation therapy ]
    Trygliciericdes in mg/dL

  24. Serologic outcome -Ferritin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Ferritin in ng/mL

  25. Serologic outcome -Fibrinogen [ Time Frame: Screening up to 28 days after radiation therapy ]
    Fibrinogen in mg/dL

  26. Serologic Immune markers flow cytometry [ Time Frame: Screening up to 28 days after radiation therapy ]
    Immune marker flow cytometry (refractive index)

  27. Serologic outcome -Bilirubin [ Time Frame: Screening up to 28 days after radiation therapy ]
    Bilirubin in mg/dL

  28. Serologic outcome - LDH [ Time Frame: Screening up to 28 days after radiation therapy ]
    Lactate Dehydrogenase in units/L

  29. Serologic outcome - Creatinine [ Time Frame: Screening up to 28 days after radiation therapy ]
    Creatinine in mg/dL

  30. Serologic outcome - EGFR [ Time Frame: Screening up to 28 days after radiation therapy ]
    Estimated Glomerular Filtration Rate in mL/min/m2

  31. Serologic outcome - CRP [ Time Frame: Screening up to 28 days after radiation therapy ]
    C-Reactive Protein in mg/L

  32. Serologic outcome - ALT [ Time Frame: Screening up to 28 days after radiation therapy ]
    Alanine Aminotransferase in units/L

  33. Serologic outcome - AST [ Time Frame: Screening up to 28 days after radiation therapy ]
    Asparatate Aminotransferase in units/L

  34. Serologic outcome - Troponin-I [ Time Frame: Screening up to 28 days after radiation therapy ]
    Troponin-I in ng/mL

  35. Serologic outcome - BNP [ Time Frame: Screening up to 28 days after radiation therapy ]
    B-Natriuretic Peptid in pg/mL

  36. Serologic outcome - Blood Gases pH [ Time Frame: Screening up to 28 days after radiation therapy ]
    pH (no unit)

  37. Serologic outcome - Blood Gases pO2 [ Time Frame: Screening up to 28 days after radiation therapy ]
    pressure of O2 in mm Hg

  38. Serologic outcome - Blood Gases pCO2 [ Time Frame: Screening up to 28 days after radiation therapy ]
    pressure of CO2 in mm Hg

  39. Serologic outcome - Lactic Acid [ Time Frame: Screening up to 28 days after radiation therapy ]
    Lactic Acid in mmol/L

  40. Serologic outcome - IL-6 [ Time Frame: Screening up to 28 days after radiation therapy ]
    Interleukin-6 in pg/mL

  41. Serologic outcome - Potassium [ Time Frame: Screening up to 28 days after radiation therapy ]
    Potassium in mmol/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366791


Contacts
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Contact: Clayton Hess, MD, MPH 404-686-2391 cbhess@emory.edu
Contact: Autumn Lunceford 404-686-1638 patricia.autumn.lee.lunceford@emory.edu

Locations
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United States, Georgia
Emory University Hospital Midtown/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30308
Contact: Clayton B. Hess       cbhess@emory.edu   
Principal Investigator: Clayton B. Hess, MD MPH         
Principal Investigator: Mohammad K. Khan, MD PhD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Clayton B Hess, MD, MPH Emory University Hospital/Winship Cancer Institute
Principal Investigator: Mohammad K Khan, MD, PhD Emory University Hospital/Winship Cancer Institute
  Study Documents (Full-Text)

Documents provided by Clayton Hess, Emory University:
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Responsible Party: Clayton Hess, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04366791    
Other Study ID Numbers: 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 )
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases