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Radiation Therapy

Low-Dose Radiotherapy for COVID-19 Pneumonia (PREVENT Trial)

Phase 2

Waitlist Available

Led By Arnab Chakravarti, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Laboratory-confirmed diagnosis of SARS-CoV-2 pneumonia

Fever > 102 degrees Fahrenheit during index admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the discharge of the last patient enrolled is estimated to be about 2 years.

Awards & highlights

PREVENT Trial Summary

This trial is testing whether low doses of radiation can help treat pneumonia caused by the COVID-19 virus.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Historically, this type of low-dose chest radiation was effective without side effects but was replaced by cheaper treatments. Side effects are not detailed here but may include typical reactions to radiation.

PREVENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with COVID-19 pneumonia.

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I had a fever over 102°F during my hospital stay.

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I need oxygen therapy to keep my oxygen levels above 93%.

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I can lie down on a treatment table for radiation therapy.

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I have had symptoms like fever, cough, or difficulty breathing for less than 9 days.

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I am currently in the hospital due to COVID-19.

PREVENT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the discharge of the last patient enrolled is estimated to be about 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the discharge of the last patient enrolled is estimated to be about 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the discharge of the last patient enrolled is estimated to be about 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical benefit of Step 2 Radiation dose

Step 1 Dose selection

Secondary outcome measures

Changes of the cost of care for the control arm versus the radiation arms

Other outcome measures

Changes in blood C-reactive protein between control and experimental arms

Changes in blood D-Dimer levels between control and experimental arms

Changes in blood IL-6 levels between control and experimental arms

+5 more

PREVENT Trial Design

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,130 Total Patients Enrolled

Varian Medical SystemsIndustry Sponsor

58 Previous Clinical Trials

3,702 Total Patients Enrolled

1 Trials studying Pneumonia

60 Patients Enrolled for Pneumonia

Arnab Chakravarti, MDPrincipal Investigator - James Cancer Hospital, Department of Radiation Oncology

Ohio State University Comprehensive Cancer Center

3 Previous Clinical Trials

543 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical trial is currently recruiting patients for enrollment. The initial post was published on August 28th 2020 and the most recent update occurred in March 2021 with a requirement of 100 participants from 7 sites."

Answered by AI

What have been the observed effects of Low dose radiation 35 cGy on patients?

"Our team at Power judged Low dose radiation 35 cGy's safety to be a 2 due to existing evidence of its security, yet lack of data in regards to efficacy."

Answered by AI

How many healthcare centers are administering this examination in the city?

"Ohio State University James Cancer Hospital in Columbus, Ohio, Indiana University School of Medicine in Indianapolis, Indiana, and Loyola University Chicago in Maywood, Illinois are the primary locations for this trial. Additionally there are 7 other medical centres offering access to this research project."

Answered by AI

What is the capacity of this clinical trial in terms of patient participants?

"Affirmative. Per the information posted on clinicaltrials.gov, this trial is open for recruitment; it was first put up 8/28/2020 and last updated 3/11/2021. The study requires 100 patients to be sourced from multiple medical sites."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

Reports of Practical Oncology and RadiotherapyJournal

Low-dose Whole Thorax Radiation Therapy for COVID-19 Pneumonia: Inpatient Onboarding Process for a Randomized Controlled Trial

McClelland III, Shearwood, Amy C. Miller, Mark D. Williams, Benjamin P. Anthony, Arnab Chakravarti, and Paul A. Anthony. 2021. “Low-dose Whole Thorax Radiation Therapy for COVID-19 Pneumonia: Inpatient Onboarding Process for a Randomized Controlled Trial”. Reports of Practical Oncology and Radiotherapy. VM Media SP. zo.o VM Group SK. doi:10.5603/rpor.a2021.0112.

clinicaltrials.govStudy

Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia

Arnab Chakravarti 2020. "Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04466683.

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