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Best Supportive Care With or Without Low Dose Whole Lung Radiation Therapy for the Treatment of COVID-19 (RESCUE1-19)

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: NCT04433949
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 22, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mohammad K. Khan, Emory University

Brief Summary:
This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.

Condition or disease Intervention/treatment Phase
Pneumonia Severe Acute Respiratory Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Other: Best Practice Radiation: Low Dose Radiation Therapy Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. Intubation-free survival (IFS) and (2) time to clinical recovery (TTCR) based on weaning off supplementary oxygenation or hospital discharge in COVID 19 patients.

SECONDARY OBJECTIVES:

I. To investigate (1) other clinical, (2) radiographic, (3) serologic markers, and (4) immune marker response to best supportive care plus provider's choice of pharmaceutical treatment either with or without whole-lung LD-RT

II. Secondary clinical improvements will look at time to hospital discharge, prevention of ICU admissions, and overall survival.

OUTLINE: Patients are blindly randomized to 1 of 2 arms.

ARM I: Patients receive best supportive care plus physician choice of treatment

ARM II: Patients receive best supportive care plus LDRT (experimental arm).

After completion of study, patients are followed up for 14 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III Trial of Best Supportive Care Plus Provider's Choice of Pharmaceutical Treatment With or Without Whole Lung Low-Dose Radiation Therapy (LD-RT) in Hospitalized Patients With COVID-19
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022


Arm Intervention/treatment
Active Comparator: Arm I (physician choice)
Patients get best supportive care + physician choice of treatment
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Experimental: Arm II (LDRT)
Patients receive best supportive care + low dose RT (whole lung)
Radiation: Low Dose Radiation Therapy
Undergo LDRT
Other Name: Low Dose Radiation




Primary Outcome Measures :
  1. Time to clinical recovery [ Time Frame: Up to follow-up day 14 after study start ]
    Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.


Secondary Outcome Measures :
  1. Freedom from ICU admission [ Time Frame: Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis. ]
    The rates from both cohort will be reported.

  2. Temperature [ Time Frame: Up to follow-up day 14 after study start ]
    Temperature in degrees (F)

  3. Heart rate [ Time Frame: Up to follow-up day 14 after study start ]
    Heart rate in beats per minutes

  4. Systolic Blood pressure [ Time Frame: Up to follow-up day 14 after study start ]
    Systolic blood pressure in mm Hg

  5. Oxygen saturation [ Time Frame: Up to follow-up day 14 after study start ]
    Oxygen saturation in percentage

  6. Supplemental oxygenation need [ Time Frame: Up to follow-up day 14 after study start ]
    Oxygen saturation in percentage

  7. Respiratory rate [ Time Frame: Up to follow-up day 14 after study start ]
    Respiratory rate in breaths per minute.

  8. Glasgow Comma Scale from minimum of 3 to maximum of 15. [ Time Frame: Up to follow-up day 14 after study start ]
    Pre and post intervention; Minimum of 3 (poor) to best (15)

  9. Performance status [ Time Frame: Up to follow-up day 14 after study start ]
    Easter Cooperative Oncology Group (ECOG) Performance Status Scale from 0-5; 0 being best; 5 being dead;

  10. Survival [ Time Frame: Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis. ]
    Survival in percentage

  11. Serial chest x-rays severe acute respiratory syndrome (SARS) scoring [ Time Frame: Up to follow-up day 14 after study start; ]
    Serial chest x-rays categorized using published scale into ordinal ranks 1-5 for SARS.

  12. Changes on computed tomography (CT) scans pre and post RT [ Time Frame: Baseline up to follow-up day 14 after study start ]
    CT scans with volume of consolidation measured in cubic centimeters.

  13. CRP [ Time Frame: Up to follow-up day 14 after study start ]
    C-Reactive Protein in mg/L

  14. Serum chemistry + complete blood cell (CBC) with differential [ Time Frame: Up to follow-up day 14 after study start ]
    Will be summarized descriptively.

  15. Blood gases pH(when available) [ Time Frame: Up to follow-up day 14 after study start ]
    pH (no unit)

  16. Albumin [ Time Frame: Up to follow-up day 14 after study start ]
    Albumin in gm/dL

  17. Procalcitonin [ Time Frame: Up to follow-up day 14 after study start ]
    Procalcitonin in ng/mL

  18. Aspartate aminotransferase (AST) [ Time Frame: Up to follow-up day 14 after study start ]
    Asparatate Aminotransferase in units/L

  19. Creatine kinase [ Time Frame: Up to follow-up day 14 after study start ]
    Creatinine in mg/dL

  20. Prothrombin time (PT)/partial thromboplastin time (PTT) [ Time Frame: Up to follow-up day 14 after study start ]
    Coagulation pathway time in seconds

  21. Troponin [ Time Frame: Up to follow-up day 14 after study start ]
    Troponin-I in ng/mL

  22. Lactate [ Time Frame: Up to follow-up day 14 after study start ]
    Lactic Acid in mmol/L

  23. NT-pBNP (cardiac injury) [ Time Frame: Up to follow-up day 14 after study start ]
    B-Natriuretic Peptid in pg/mL

  24. Gamma-glutamyl transferase (GGT) [ Time Frame: Up to follow-up day 14 after study start ]
    Gamma-glutamyl transferase in units/L

  25. Triglycerides [ Time Frame: Up to follow-up day 14 after study start ]
    Trygliciericdes in mg/dL

  26. Fibrinogen [ Time Frame: Up to follow-up day 14 after study start ]
    Fibrinogen in mg/dL

  27. Changes in CD8 T cells [ Time Frame: Up to follow-up day 14 after study start ]
    Will be summarized descriptively.

  28. Changes in CD4 T cells [ Time Frame: Up to follow-up day 14 after study start ]
    Will be summarized descriptively.

  29. Changes in serum antibodies against COVID-19 epitope [ Time Frame: Up to follow-up day 14 after study start ]
    Will be summarized descriptively.

  30. LDH [ Time Frame: Up to follow-up day 14 after study start ]
    Lactate Dehydrogenase in units/L

  31. D-Dimer [ Time Frame: Up to follow-up day 14 after study start ]
    D-Dimer in ng/mL

  32. IL-6 [ Time Frame: Up to follow-up day 14 after study start ]
    Interleukin-6 in pg/mL

  33. Myoglobin [ Time Frame: Up to follow-up day 14 after study start ]
    Myoglobin in ng/mL

  34. Potassium [ Time Frame: Up to follow-up day 14 after study start ]
    Potassium in mmol/L

  35. Ferritin [ Time Frame: Up to follow-up day 14 after study start ]
    Ferritin in ng/mL

  36. ALT [ Time Frame: Up to follow-up day 14 after study start ]
    Alanine Aminotransferase in units/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:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be age 50 or over; Not pregnant (will undergo pregnancy testing if below age 55);
  • Have had a positive PCR-based test confirming the diagnosis of COVID-19 within 5 days (+/-2 day)of study enrollment*
  • Have had clinical signs of severe acute respiratory syndrome or pneumonia (ie. dyspnea, cough,fever) that primary team feels like patient needs rescuing with LD-RT.**
  • Have visible bilateral consolidations/ground glass opacities on chest imaging
  • Require supplemental oxygen at the time of enrollment, defined by inability to wean from supplemental oxygen within 24 hours prior to enrollment.
  • Not require intubation within 12 hours of randomization (ie, not screen fail). Intubation after enrollment but within 12 hours of randomization will be defined as a screen failure for both the LD-RT and control cohorts.
  • Be enrolled within 5 days (+/- 2) of first hospitalization for COVID-19. Prior hospitalization for COVID-19 will be an exclusion criteria (prior ED visits are permissible).
  • 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:

  • Pregnant and/or planned to be pregnant within in next 6 months
  • Age 49 or younger at time of enrollment
  • Prior inpatient hospitalization for COVID-19 (prior emergency department [ED] visits are not an exclusion criteria)
  • Prior enrollment on a separate COVID-19-related therapeutric trial (subsequent co-enrollment is permitted for patinets randomized to the control arm).
  • Notably, concurrent use of COVID-directed therapies is no longer an exclusion criteria for this trial. This includes azithromycin, dexamethasone, remdesevir, convalescent plasma, or any other COVIDdirected drug therapy.

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): NCT04433949


Contacts
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Contact: Mohammad K Khan, MD, PhD 404-778-3473 drkhurram2000@gmail.com
Contact: Clayton B Hess, MD, MPH 404-616-3947 cbhess@emory.edu

Locations
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United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Allyson Anderson    404-251-2854    allyson.anderson@emory.edu   
Contact: Autumn Lunceford    404-686-1855    patricia.autumn.lee.lunceford@emory.edu   
Principal Investigator: Mohammad K. Khan, MD, PhD         
Principal Investigator: Clayton B. Hess, MD,MPH         
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mohammad K Khan, MD, PhD Emory University Hospital/Winship Cancer Institute
Additional Information:
Publications:
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Responsible Party: Mohammad K. Khan, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04433949    
Other Study ID Numbers: STUDY00000781
NCI-2020-04061 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD5049-20 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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
Keywords provided by Mohammad K. Khan, Emory University:
Radiotherapy
COVID-19
low dose radiotherapy
anti-inflammatory
cytokine storm
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Laboratory Infection
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Occupational Diseases