Clinical trial NCT04393948: Lung Irradiation for COVID-19 Pneumonia
Official title: Pilot Study of Low-Dose Single or Bilateral Whole Lung Irradiation for SARS-CoV-2 Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: SARS-CoV 2
Keywords: SARS-CoV-2
Radiation Therapy
COVID-19
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria

* Diagnosis of SARS-CoV-2 infection by RT-PCR or another approved laboratory test ≤ 3 days before enrollment or ≤ 14 days before enrollment with progressive disease suggestive of ongoing SARS-CoV-2 infection; retesting allowed
* Current hospitalization for ≤ 14 days with SARS-CoV-2 infection at the time of enrollment
* Use of supplemental oxygen or oxygen saturation ≤ 94% on room air
* Age ≥ 40
* May receive antiviral medication (e.g., remdesivir, lopinavir/ritonavir, oseltamivir, favipiravir), antibiotics (e.g., azithromycin), chloroquine, hydroxychloroquine, corticosteroids, statins, anticoagulation, antiplatelet agents (e.g., aspirin) and/or convalescent plasma from recovered individuals off study and/or on study if permitted by the other protocol

Exclusion criteria

* Prior or planned treatment with interleukin inhibitors (e.g., tocilizumab, canakinumab, sarilumab) or TNF-α inhibitors within 14 days of enrollment
* Prior lobectomy or pneumonectomy
* Prior thoracic radiotherapy with cumulative lung V20 \> 15% to either lung within 1 year of enrollment, or any radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment
* Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radiosensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin or gemcitabine
* Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment
* Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class ≥ 3 congestive heart failure
* History of bone marrow or solid organ transplantation
* Known history of autoimmune collagen vascular disease, e.g., scleroderma
* Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia
* Pregnancy
* Inability to be positioned supine and flat for radiation planning and delivery
* Inability to provide informed consent or lack of an authorized representative who can provide informed consent

Primary outcomes:
measure: Phase 1: Feasibility and safety of treating hospitalized patients with SARS-CoV-2 pneumonia with single or bilateral whole lung irradiation
timeFrame: 4 days after randomization
measure: Phase 2: Proportion with clinical improvement on a 7-point ordinal scale on day 4 after randomization
timeFrame: 4 days after randomization
Secondary outcomes:
measure: Improvement or worsening on the 7-point ordinal scale over additional intervals
timeFrame: Up to 30 days after randomization
measure: Rate and duration of use of supplemental oxygen
timeFrame: Up to 30 days after randomization
measure: Rate and duration of fever > 38ºC
timeFrame: Up to 30 days after randomization
measure: Rate and duration of invasive mechanical ventilation
timeFrame: Up to 30 days after randomization
measure: Duration of hospitalization
timeFrame: Up to 30 days after randomization
measure: Proportion of participants with overall survival up to 30 days after randomization
timeFrame: Up to 30 days after randomization
measure: 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
timeFrame: Up to 30 days after randomization
measure: Treatment-emergent adverse events
timeFrame: Up to 30 days after randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David Kozono, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: