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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-24

Study Completion Date

2022-03-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supportive care (low-dose radiation therapy)

Patients undergo 1 fraction of low-dose radiation therapy.

Group Type EXPERIMENTAL

Low Dose Radiation Therapy

Intervention Type RADIATION

Undergo low-dose radiation therapy

Interventions

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Low Dose Radiation Therapy

Undergo low-dose radiation therapy

Intervention Type RADIATION

Other Intervention Names

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Low Dose Radiation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No