AzTrials
AzTrials

SARS-CoV 2NCT04393948

Lung Irradiation for COVID-19 Pneumonia

A study testing Phase 1 and Phase 2 in people with SARS-CoV 2, run by Brigham and Women's Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
SARS-CoV 2
What is being tested?
Phase 1 and Phase 2
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
19 Jun 2020to Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Pilot Study of Low-Dose Single or Bilateral Whole Lung Irradiation for SARS-CoV-2 Pneumonia

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
Being tested
Phase 1, Phase 2
Keywords
SARS-CoV-2, Radiation Therapy, COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phase 1Radiation

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

  • Phase 1Radiation

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

  • Phase 2Radiation

    Arm A - No irradiation

  • Phase 2Radiation

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

  • Phase 2Radiation

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

Study groups in NCT04393948
Study groupRoleWhat they receive
No irradiationExperimentalNot described
Receives: Radiation: Phase 2
100 cGy single lung irradiationExperimental100 cGy single lung radiation
Receives: Radiation: Phase 1; Radiation: Phase 2
100 cGy bilateral lung irradiationExperimental100 cGy bilateral lung radiation
Receives: Radiation: Phase 1; Radiation: Phase 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 days after randomization

  2. 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

    Measured: 4 days after randomization

Secondary outcomes (8)

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

    Measured: Up to 30 days after randomization

  2. Rate and duration of use of supplemental oxygen

    Measured: Up to 30 days after randomization

  3. Rate and duration of fever > 38ºC

    Measured: Up to 30 days after randomization

  4. Rate and duration of invasive mechanical ventilation

    Measured: Up to 30 days after randomization

  5. Duration of hospitalization

    Measured: Up to 30 days after randomization

  6. Proportion of participants with overall survival up to 30 days after randomization

    Measured: Up to 30 days after randomization

  7. 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

    Measured: Up to 30 days after randomization

  8. Treatment-emergent adverse events

    Measured: Up to 30 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start19 Jun 2020
  3. Primary completionJun 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04393948
Sponsor's protocol ID
2020P001494
Status last verified
Jan 2022
First submitted
15 May 2020
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Phase 1 and Phase 2 in people with SARS-CoV 2, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Feasibility and safety of treating hospitalized patients with SARS-CoV-2 pneumonia with single or bilateral whole lung irradiation (time frame: 4 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in