BridgeMD
New treatment option for COVID-19
Official title Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
ClinicalTrials.gov ID: NCT04427566
What this study is testing
- What it's testing
- Low doses of radiation in the form of chest X-rays have been used to treat people with pneumonia. This treatment was found to be effective by reducing inflammation and with minimal side effects.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.