Lung Irradiation for COVID-19 Pneumonia

NCT04393948 | Withdrawn FDA Device

• 1 other identifier: 2020P001494
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV-2; Radiation Therapy; COVID-19

Outcome Measures

Primary Outcomes (2)

• Phase 1: Feasibility and safety of treating hospitalized patients with SARS-CoV-2 pneumonia with single or bilateral whole lung irradiation

  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

  4 days after randomization

• Phase 2: Proportion with clinical improvement on a 7-point ordinal scale on day 4 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

  4 days after randomization

Secondary Outcomes (8)

• Improvement or worsening on the 7-point ordinal scale over additional intervals

  Up to 30 days after randomization

• Rate and duration of use of supplemental oxygen

  Up to 30 days after randomization

• Rate and duration of fever > 38ºC

  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

Study Arms (3)

No irradiation

EXPERIMENTAL

Radiation: Phase 2

100 cGy single lung irradiation

EXPERIMENTAL

100 cGy single lung radiation

Radiation: Phase 1; Radiation: Phase 2

100 cGy bilateral lung irradiation

EXPERIMENTAL

100 cGy bilateral lung radiation

Radiation: Phase 1; Radiation: Phase 2

Interventions

Phase 1 RADIATION

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

100 cGy single lung irradiation

Phase 2 RADIATION

Arm A - No irradiation

No irradiation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David Kozono, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Radiation Oncologist

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: June 19, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)