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

NCT04366791 | Terminated Phase 1 DMC FDA Device

• 4 other identifiers: STUDY00000476NCI-2020-02676RAD5002-20P30CA138292
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening up to 28 days after radiation therapy

Secondary Outcomes (41)

• Clinical outcome - Temperature

  Screening up to 28 days after radiation therapy

• Clinical outcome - Heart Rate

  Screening up to 28 days after radiation therapy

• Clinical outcome - Systolic blood pressure

  Screening up to 28 days after radiation therapy

• Clinical outcome - Oxygenation

  Screening up to 28 days after radiation therapy

• Clinical outcome - Respirations

  Screening up to 28 days after radiation therapy

Study Arms (1)

Supportive care (low-dose radiation therapy)

EXPERIMENTAL

Patients undergo 1 fraction of low-dose radiation therapy.

Radiation: Low Dose Radiation Therapy

Interventions

Low Dose Radiation Therapy RADIATION

Undergo low-dose radiation therapy

Also known as: Low Dose Radiation

Supportive care (low-dose radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University Hospital Midtown/Winship Cancer Institute

Atlanta, Georgia, 30308, United States

Location

Emory Saint Joseph's Hosptial

Atlanta, Georgia, 30342, United States

Location

Related Publications (1)

• 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.

  PMID: 34653525 DERIVED

MeSH Terms

Conditions

Pneumonia; COVID-19; Severe Acute Respiratory Syndrome

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Mohammad Khan, MD, PhD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Study Start: April 24, 2020
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)