Lung Irradiation for COVID-19 Pneumonia
- Conditions
- SARS-CoV 2
- Interventions
- Radiation: Phase 1Radiation: Phase 2
- Registration Number
- NCT04393948
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
In this research study the investigators want to learn more about the potential benefit of radiation to the lung to improve the health of patients who are hospitalized with Coronavirus-19 (COVID-19) due to infection with a virus called SARS-CoV-2. This infection causes inflammation of the lung, which can make it difficult to breathe. As a result, patients may need supplemental oxygen or be placed on a ventilator. The investigators believe that low dose radiation therapy to the lung may reduce this inflammation and increase the likelihood that patients will need less oxygen support such as ventilation or supplemental oxygen, or be discharged from the hospital in fewer days, compared to without radiation therapy. The amount of radiation is much lower than what is typically used to treat other conditions such as cancer, although it is higher than the dose used for routine medical imaging.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 cGy single lung irradiation Phase 1 100 cGy single lung radiation 100 cGy bilateral lung irradiation Phase 1 100 cGy bilateral lung radiation 100 cGy bilateral lung irradiation Phase 2 100 cGy bilateral lung radiation No irradiation Phase 2 - 100 cGy single lung irradiation Phase 2 100 cGy single lung radiation
- Primary Outcome Measures
Name Time Method Phase 1: Feasibility and safety of treating hospitalized patients with SARS-CoV-2 pneumonia with single or bilateral whole lung irradiation 4 days after randomization Subjects will be treated with 100 cGy irradiation to a single (right-sided) lung (dose level 1) or 100 cGy irradiation to both lungs (dose level 2) following a 3 + 3 dose escalation scheme
Phase 2: Proportion with clinical improvement on a 7-point ordinal scale on day 4 after randomization 4 days after randomization The ordinal scale is an assessment of the clinical status on a given day. Each day, the worst (lowest) score from the previous day will be recorded as the score for that previous day.
The scale is as follows:
1. Death
2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO)
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
4. Hospitalized, requiring low flow supplemental oxygen
5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care
7. Not hospitalized
- Secondary Outcome Measures
Name Time Method Rate and duration of fever > 38ºC Up to 30 days after randomization Proportion of participants with overall survival up to 30 days after randomization Up to 30 days after randomization Treatment-emergent adverse events Up to 30 days after randomization Rate and duration of use of supplemental oxygen Up to 30 days after randomization Improvement or worsening on the 7-point ordinal scale over additional intervals Up to 30 days after randomization Improvement in radiographic findings related to infection/inflammation; comparisons include on study versus baseline scans and irradiated vs. unirradiated lung in subjects randomized to receive single lung irradiation Up to 30 days after randomization Rate and duration of invasive mechanical ventilation Up to 30 days after randomization Duration of hospitalization Up to 30 days after randomization
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States