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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
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with COVID-19 pneumonia.
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I had a fever over 102°F during my hospital stay.
Select...
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.
Select...
I am currently in the hospital due to COVID-19.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit of Step 2 Radiation dose
Step 1 Dose selection
Secondary study objectives
Changes of the cost of care for the control arm versus the radiation arms
Other study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
293,273 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
62 Previous Clinical Trials
3,747 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