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NCT04466683 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia
A Phase 2 study of COVID-19 and Pneumonia, sponsored by Ohio State University Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 7
- Study locations
NCT04466683: Active Phase 2 study of COVID-19 and Pneumonia, sponsored by Ohio State University Comprehensive Cancer Center.
NCT04466683 is a Phase 2 study of COVID-19 and Pneumonia that is active but no longer recruiting, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 37 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04466683, a Phase 2 study of COVID-19 and Pneumonia, is active but no longer recruiting, sponsored by Ohio State University Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
The rate of grade 4 toxicity, the rate of mechanical ventilation, the rate of hospital stay greater than 10 days, and the crude all-cause mortality rate will be used to calculate the clinically meaningful event rate (CMER). The rates range would be from 0 to 100% with a lower rate indicating a more favorable dose.
Conditions Studied
Interventions
- RADIATION Low dose radiation 35 cGy
- RADIATION High dose radiation 100 cGy
Study Locations (7)
Florida
- Boca Raton Regional Hospital Lynn Cancer Institute - Boca Raton
- Miami Cancer Institute - Miami
Illinois
- Loyola University Chicago - Maywood
Indiana
- Indiana University School of Medicine - Indianapolis
Massachusetts
- Lowell General Hospital Cancer Center - Lowell
Ohio
- Ohio State University James Cancer Hospital - Columbus
Other
- Hospital Universitario San Ignacio - Bogotá
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04466683 still lists
NCT04466683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Low dose radiation 35 cGy is the first listed.
NCT04466683 lists 7 locations in 6 states (Florida, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT04466683 about?
NCT04466683 is a clinical study titled "Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia". 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 treatme...
What is the current status of trial NCT04466683?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2020-08-28. Estimated completion is 2025-12-31.
What conditions does trial NCT04466683 study?
This clinical trial studies the following conditions: COVID-19, Pneumonia, SARS-CoV-2.
What interventions are being tested in trial NCT04466683?
The interventions under investigation include: Low dose radiation 35 cGy (RADIATION), High dose radiation 100 cGy (RADIATION).
Who is sponsoring clinical trial NCT04466683?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04466683 being conducted?
This trial has 7 study locations across Florida, Illinois, Indiana, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04466683's enrollment target sits among peer trials
37 261st of 298 higher than 38 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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