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Lung Irradiation for COVID-19 Pneumonia

Primary Purpose

SARS-CoV 2

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Phase 1

Phase 2

About this trial

This is an interventional treatment trial for SARS-CoV 2 focused on measuring SARS-CoV-2, Radiation Therapy, COVID-19

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

No irradiation

100 cGy single lung irradiation

100 cGy bilateral lung irradiation

Arm Description

100 cGy single lung radiation

100 cGy bilateral lung radiation

Outcomes

Primary Outcome Measures

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

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: Death Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring low flow supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care Not hospitalized

Secondary Outcome Measures

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

Rate and duration of use of supplemental oxygen

Rate and duration of fever > 38ºC

Rate and duration of invasive mechanical ventilation

Duration of hospitalization

Proportion of participants with overall survival 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

Treatment-emergent adverse events

Full Information

NCT ID

NCT04393948

First Posted

May 15, 2020

Last Updated

January 21, 2022

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04393948

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of accrual

Study Start Date

June 19, 2020 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV 2

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No irradiation

Arm Type

Experimental

Arm Title

100 cGy single lung irradiation

Arm Type

Experimental

Arm Description

100 cGy single lung radiation

Arm Title

100 cGy bilateral lung irradiation

Arm Type

Experimental

Arm Description

100 cGy bilateral lung radiation

Intervention Type

Radiation

Intervention Name(s)

Phase 1

Intervention Description

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

Intervention Name(s)

Phase 1

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Phase 2

Intervention Description

Arm A - No irradiation

Intervention Type

Radiation

Intervention Name(s)

Phase 2

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Phase 2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 days after randomization

Title

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

Description

Time Frame

4 days after randomization

Secondary Outcome Measure Information:

Title

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

Time Frame