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

  • STATUS
    Recruiting
  • participants needed
    52
  • sponsor
    Emory University
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Updated on 16 February 2024
See if I qualify
fever
dyspnea
pneumonia
blood tests
cough
covid-19
chest imaging
discomforts
acute respiratory syndrome (sars)

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.

Description

PRIMARY OBJECTIVE:

I. Time to clinical recovery based on reducing the need of supplementary oxygenation in COVID 19 patients.

SECONDARY OBJECTIVES:

I. To investigate (1) clinical, (2) radiographic, and (3) immune marker response to whole-lung LDRT compared to best standard of care.

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.

Details
Condition Pulmonary Disease, Upper respiratory infection, Pneumonia, Pneumonia, Severe Acute Respiratory Syndrome, Symptomatic COVID-19 Infection Laboratory-Confirmed
Age 18years - 100years
Treatment Best Practice, Low Dose Radiation Therapy
Clinical Study IdentifierNCT04433949
SponsorEmory University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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, fever) that primary team feels like needs rescuing with treatments
Have visible consolidations/ground glass opacities on chest imaging
Requiring supplemental oxygen
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 prior to randomization: Remdesivir or whatever drug may have been approved as standard of care to treat COVID patients. After consenting and randomization, patient could get remdesivir and/or other approved standard of care treatments on the standard of care arm as physician's choice. However, they would not be allowed to receive this on the radiotherapy arm until interim analysis is completed (i.e., after the first 8 patients enrolled on both arms with at least 14 day follow-up. This would especially be the case, if we see a vast superiority of one arm over another for the primary endpoints, that puts patients at risks from obtaining the standard of care treatments) However, patient could recieve such therapy if they are mechanically ventilated
Pregnant and/or planned to be pregnant within in next 6 months
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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