Low dose radiation therapy for COVID-19 patients with lung issues
Vented COVID: A Phase II Study Of The Use Of Ultra Low-Dose Bilateral Whole Lung Radiation Therapy in the Treatment Of Critically Ill Patients With COVID-19 Respiratory Compromise
This study is testing if low-dose radiation therapy can help COVID-19 patients with lung problems who need breathing support to survive better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04427566 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of low-dose radiation therapy to treat patients with COVID-19 who are experiencing respiratory compromise and require mechanical ventilation. The approach aims to reduce lung inflammation caused by the virus and the immune response, potentially improving survival rates. Patients will receive a single treatment of ultralow dose whole lung radiation therapy (ULD-WLRT), and the primary outcome will be the mortality rate 30 days after starting mechanical ventilation. An interim analysis will determine if the trial continues based on the survival of initial participants.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with COVID-19 pneumonia who are currently receiving ICU-based mechanical ventilation.
Not a fit: Patients who are moribund with a life expectancy of less than 24 hours or those not committed to full disease-specific therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in critically ill COVID-19 patients requiring ventilation.
How similar studies have performed: While the use of radiation therapy for pneumonia has historical precedent, this specific application for COVID-19 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laboratory Diagnosis of COVID-19 based within 14 days of enrollment. * CT or radiographic findings typical of COVID-19 pneumonia within 5 days of enrollment * Receiving ICU-based mechanical ventilation * Life expectancy ≥ 24 hours, as judged by investigator * Hypoxemia defined as a Pa/FIO2 ratio \< 300 or SpO2/FiO2 \< 315 * Signed informed consent by patient or his or her legal/authorized representative Exclusion Criteria: * Moribund with survival expected \< 24 hours, as judged by investigator and treating team * Expected survival \< 30 days, as judged by investigator and treating team, due to chronic illness present prior to COVID infection * Patient or legal representative not committed to full disease specific therapy, i.e. comfort care (DNRCCA is allowed) * Treatment with immune suppressing medications in the last 30 days (steroids for acute respiratory distress syndrome or septic shock allowed) * Presumed COVID-associated illness greater than 14-days * Inpatient admission greater than 14-days * Patient deemed unsafe for travel for radiation therapy * Chronic hypoxemia requiring supplemental oxygen at baseline * Documented active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis * History of prior radiation therapy resulting in ≥grade 2 radiation pneumonitis within 365 days of enrollment * Active or history of prior radiation to the thorax completed within 180 days of enrollment (skin or surface only skin treatments are acceptable) * Known active uncontrolled bacterial or fungal infections of the lung. * Active cytotoxic chemotherapy * Females who are pregnant or have a positive pregnancy test * Breast feeding * Note: concurrent administration of convalescent immune plasma therapy either on clinical trial or as a standard therapy not an exclusion criterion, but will be noted
Where this trial is running
Columbus, Ohio
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Arnab Chakravarti — James Cancer Hospital, Department of Radiation Oncology
- Study coordinator: Arnab Chakravarti
- Email: Arnab.Chakravarti@osumc.edu
- Phone: 614-293-0672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.