Clinical trial NCT04366791: Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pneumonia
Coronavirus Infection in 2019 (COVID-19)
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of extubation (for intubated patients)
timeFrame: Screening up to 28 days after radiation therapy
Secondary outcomes:
measure: Clinical outcome - Temperature
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Heart Rate
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Systolic blood pressure
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Oxygenation
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Respirations
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - FiO2
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - PEEP
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Tidal volume
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Intubation/Extubation events
timeFrame: Screening up to 28 days after radiation therapy
measure: Clinical outcome - Overall survival
timeFrame: Screening up to 28 days after radiation therapy
measure: Radiographic outcome - Chest xray
timeFrame: Screening up to 28 days after radiation therapy
measure: Radiographic outcome - CT can
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - WBC
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Hgb
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Procalcitonin
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - ANC
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Creatine kinase
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Myoglobin
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Albumin
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - PT/PTT
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - D-Dimer
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - GGT
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome -Triglycerides
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome -Ferritin
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome -Fibrinogen
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic Immune markers flow cytometry
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome -Bilirubin
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - LDH
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Creatinine
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - EGFR
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - CRP
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - ALT
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - AST
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Troponin-I
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - BNP
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Blood Gases pH
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Blood Gases pO2
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Blood Gases pCO2
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Lactic Acid
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - IL-6
timeFrame: Screening up to 28 days after radiation therapy
measure: Serologic outcome - Potassium
timeFrame: Screening up to 28 days after radiation therapy
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hosptial
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Mohammad Khan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.