37 Participants Needed

Low-Dose Radiotherapy for COVID-19 Pneumonia

(PREVENT Trial)

Recruiting at 7 trial locations
AC
KM
Overseen ByKimberly Mahler
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What data supports the effectiveness of the treatment Low-Dose Radiotherapy for COVID-19 Pneumonia?

Research suggests that low-dose radiation therapy, typically between 0.5 to 1.5 Gy, may help improve viral pneumonia, including COVID-19 pneumonia, by reducing inflammation in the lungs. Studies have shown that this approach is considered feasible and safe, with potential benefits outweighing the risks of radiation exposure.12345

Is low-dose radiotherapy safe for treating COVID-19 pneumonia?

There are ongoing studies on low-dose radiotherapy for COVID-19 pneumonia, but the safety is uncertain due to potential risks like cancer and circulatory disease. Some evidence suggests anti-inflammatory benefits, but the overall safety in humans remains unclear.16789

How does low-dose radiotherapy differ from other treatments for COVID-19 pneumonia?

Low-dose radiotherapy for COVID-19 pneumonia is unique because it uses small doses of radiation to potentially reduce inflammation in the lungs, unlike standard drug treatments. This approach is based on historical data suggesting that low doses of radiation can help with viral pneumonia, and it is being explored due to the lack of effective drug treatments for COVID-19 pneumonia.1231011

What is the purpose of this trial?

Low doses of radiation in the form of chest x-rays has been in the past to treat people with pneumonia. This treatment was thought to reduce inflammation and was found to be effective without side effects. However, it was an expensive treatment and was eventually replaced with less expensive treatment options like penicillin.The COVID-19 virus has emerged recently, causing high rates of pneumonia in people. The authors believe that giving a small dose of radiation to the lungs may reduce inflammation and neutralize the pneumonia caused by COVID-19. For this study, the x-ray given is called radiation therapy. Radiation therapy uses high-energy X-ray beams from a large machine to target the lungs and reduce inflammation. Usually, it is given at much higher doses to treat cancers.The purpose of this study is to find out if adding a single treatment of low-dose x-rays to the lungs might reduce the amount of inflammation in the lungs from COVID-19 infection, which could reduce the need for a ventilator or breathing tube.

Research Team

AC

Arnab Chakravarti, MD

Principal Investigator

James Cancer Hospital, Department of Radiation Oncology

Eligibility Criteria

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

I have been diagnosed with COVID-19 pneumonia.
I had a fever over 102°F during my hospital stay.
I need oxygen therapy to keep my oxygen levels above 93%.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 week
1 visit (in-person)

Evaluation and Dose Selection

Evaluation of clinical benefit, risk profile, and biomarker changes to select the best radiotherapy dose-arm for Step 2

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in blood markers and clinical outcomes

Up to 2 years
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • High dose radiation 100 cGy
  • Low dose radiation 35 cGy
Trial Overview The trial tests if low-dose radiation therapy (35 cGy) can reduce lung inflammation in COVID-19 pneumonia, potentially decreasing ventilator reliance. It's compared against a higher dose (100 cGy). The x-ray beams target the lungs in a single session.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Low radiation armExperimental Treatment1 Intervention
A single dose of 35 cGY delivered to the whole thorax
Group II: High radiation armExperimental Treatment1 Intervention
A single dose of 100 cGY delivered to the whole thorax
Group III: Control armActive Control1 Intervention
Patients will receive no radiation therapy but will have research samples collected and best supportive care

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Varian Medical Systems

Industry Sponsor

Trials
63
Recruited
3,700+

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

References

Pneumonia After Bacterial or Viral Infection Preceded or Followed by Radiation Exposure: A Reanalysis of Older Radiobiologic Data and Implications for Low-Dose Radiation Therapy for Coronavirus Disease 2019 Pneumonia. [2022]
Low-Dose Radiotherapy for Patients with Pneumonia Due to COVID-19: A Single-Institution Prospective Study. [2023]
Efficacy of low-dose lung radiotherapy in the management of COVID-19 patients: a randomised, open-label study. [2023]
The Theoretical Value of Whole-Lung Irradiation for COVID-19 Pneumonia: A Reasonable and Safe Solution until Targeted Treatments are Developed. [2021]
Low-dose Lung Radiotherapy for COVID-19-related Pneumonia: Preliminary Results of the Italian Mono-institutional COLOR-19 Trial. [2022]
Estimating cancer risks due to whole lungs low dose radiotherapy with different techniques for treating COVID-19 pneumonia. [2022]
Effectiveness of low-dose radiation therapy to improve mortality of COVID-19. [2022]
Is there any supportive evidence for low dose radiotherapy for COVID-19 pneumonia? [2020]
Low-Dose Radiation Therapy (LDRT) for COVID-19: Benefits or Risks? [2023]
Low-dose radiation therapy for COVID-19 pneumopathy: what is the evidence? [2020]
Saving time in the radiotherapy procedures for COVID-19 pneumonia treatment. A single-institution experience. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security