Lung Irradiation for COVID-19 Pneumonia

NCT ID: NCT04393948

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-19
• Study Completion Date: 2021-09-30

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.

Conditions

SARS-CoV 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No irradiation

Group Type: EXPERIMENTAL

Phase 2

Intervention Type: RADIATION

Arm A - No irradiation

100 cGy single lung irradiation

100 cGy single lung radiation

Group Type: EXPERIMENTAL

Phase 1

Intervention Type: RADIATION

Dose Level 1 - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator

Phase 2

Intervention Type: RADIATION

Arm B - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator

100 cGy bilateral lung irradiation

100 cGy bilateral lung radiation

Group Type: EXPERIMENTAL

Phase 1

Intervention Type: RADIATION

Dose Level 2 - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator

Phase 2

Intervention Type: RADIATION

Arm C - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator

Interventions

Phase 1

Dose Level 1 - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator

Intervention Type: RADIATION

Phase 1

Dose Level 2 - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator

Intervention Type: RADIATION

Phase 2

Arm A - No irradiation

Intervention Type: RADIATION

Phase 2

Arm B - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator

Intervention Type: RADIATION

Phase 2

Arm C - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator

Intervention Type: RADIATION

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David E. Kozono

Associate Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kozono, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P001494

Identifier Type: -

Identifier Source: org_study_id