Low-Dose Radiotherapy for COVID-19 Pneumonia
(PREVENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether low-dose x-ray treatments can reduce lung inflammation caused by COVID-19 pneumonia. By using radiation therapy, typically applied in higher doses for cancer, researchers aim to decrease pneumonia symptoms and reduce ventilator use. Participants will receive either a low dose (35 cGy), high dose (100 cGy), or no radiation to compare effects. Individuals who have tested positive for COVID-19, are hospitalized with pneumonia symptoms, and have specific breathing difficulties might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking findings.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude those with a history of using certain drugs like Bleomycin and Methotrexate, so it's best to discuss your medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that low-dose radiation therapy has been safely used for lung conditions in the past. Early results suggest it might help reduce lung inflammation in COVID-19 patients. Studies indicate that low-dose whole-lung radiation is safe and shows promise in treating COVID-19 pneumonia. At these low doses, much lower than those used for cancer treatment, no significant side effects have been reported.
For the higher dose of 100 cGy, past research has examined similar treatments. Although specific safety data for this exact dose isn't detailed, studies of higher doses in other contexts have not reported major safety issues. These findings offer some reassurance about the safety of these doses, but ongoing trials are important to confirm these results.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using low-dose radiotherapy for COVID-19 pneumonia because it offers a novel approach compared to standard treatments like antivirals and corticosteroids. Unlike these conventional methods, low-dose radiation targets inflammation directly in the lungs, which may help reduce severe symptoms more quickly. Additionally, this approach may work rapidly, potentially providing relief in just a few days, which is crucial for patients experiencing acute respiratory distress. By exploring both low and high doses of radiation, researchers aim to pinpoint the most effective and safest way to harness this technology for treating COVID-19 pneumonia.
What evidence suggests that this trial's treatments could be effective for COVID-19 pneumonia?
This trial will compare low-dose and high-dose radiation therapy for COVID-19 pneumonia. Research has shown that low-dose radiation therapy, which participants in the low radiation arm will receive, might help reduce lung inflammation caused by COVID-19 pneumonia. Studies have found that small amounts of radiation, like 35 cGy, can lower inflammation without causing side effects. Participants in the high radiation arm will receive a higher dose of 100 cGy, where earlier research observed early improvements in oxygen levels and quicker recovery times. The main idea is that radiation targets the lungs to stop excessive inflammation, the primary issue in COVID-19 pneumonia. This method has worked in the past for other types of pneumonia and is now being tested for COVID-19.13567
Who Is on the Research Team?
Arnab Chakravarti, MD
Principal Investigator
James Cancer Hospital, Department of Radiation Oncology
Are You a Good Fit for This Trial?
This trial is for hospitalized COVID-19 patients with confirmed pneumonia, experiencing symptoms like fever and cough for less than 9 days. They must have a high respiratory rate or need oxygen to maintain blood oxygen levels. Participants should be able to lie on the treatment couch and consent to the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Initial Treatment
Participants are randomized to receive either standard care or low-dose whole thorax megavoltage radiotherapy (LD-WTRT) at 35 cGy or 100 cGy
Evaluation and Dose Selection
Evaluation of clinical benefit, risk profile, and biomarker changes to select the best radiotherapy dose-arm for Step 2
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in blood markers and clinical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- High dose radiation 100 cGy
- Low dose radiation 35 cGy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Varian Medical Systems
Industry Sponsor
Dow R. Wilson
Varian Medical Systems
Chief Executive Officer since 2012
MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University
Dr. Deepak Khuntia
Varian Medical Systems
Chief Medical Officer since 2020
MD from the University of Cambridge, PhD from the University of Leicester