Status:
ACTIVE_NOT_RECRUITING
Low-Dose Radiotherapy For Patients With SARS-COV-2 (COVID-19) Pneumonia
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Covid-19
Sars-CoV2
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Low doses of radiation in the form of chest x-rays has been in the past to treat people with pneumonia. This treatment was thought to reduce inflammation and was found to be effective without side eff...
Detailed Description
The authors propose a two-step randomized Phase II study to determine if single fraction low dose whole thorax megavoltage radiotherapy (LD-WTRT) can produce meaningful clinical benefit in COVID-19 pa...
Eligibility Criteria
Inclusion
- Laboratory-confirmed diagnosis of SARS-CoV-2 pneumonia
- Currently hospitalized with COVID-19
- Symptomatic fever, cough and/or dyspnea for \< 9 days
- Patient or legal/authorized representative can understand and sign the study informed consent document
- Able to be positioned on a linear-accelerator couch for Radiation Therapy delivery
- And at least one of the following risk factors for significant pulmonary compromise:
- Fever \> 102 degrees Fahrenheit during index admission
- Respiratory rate of ≥ 26 / minute within 24 hours of screening
- SpO2 ≤ 95% on room air within 24 hours of screening
- Any patient requiring 4 L/min oxygen therapy to maintain SpO2 \>93% within 24 hours of screening
- Ratio of partial pressure of arterial oxygen to fraction of inspired air \< 320.
- Patients may be enrolled on this trial while concurrently enrolled on other COVID-19 clinical trials.
Exclusion
- Currently requiring mechanical ventilation
- Prior thoracic radiotherapy, with the exception of the following:
- Breast or post-mastectomy chest wall radiation (without regional nodal irradiation) may be included at the discretion of the site primary investigator, and
- Thoracic skin radiation therapy (without regional nodal irradiation) is allowed.
- Known hereditary syndrome with increased sensitivity to radiotherapy, including ataxia-telangiectasia, xeroderma pigmentosum, and Nijmegen Breakage Syndrome
- Known prior systemic use of the following drugs: Bleomycin, Carmustine, Methotrexate, Busulfan, Cyclophosphamide, or Amiodarone
- History of or current diagnosis of pulmonary fibrosis, or an alternative pulmonary condition responsible for significant lung compromise at the discretion of the site primary investigator
- History of lung lobectomy or pneumonectomy
- Known history of pulmonary sarcoidosis, Wegener's granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, polymyositis/dermatomyositis, Sjögren's syndrome, mixed connective tissue disease, Churg-Strauss syndrome, Goodpasture's syndrome, or ankylosing spondylitis.
- Symptomatic congestive heart failure within the past 6 months including during current hospitalization
- History of recent or current malignancy receiving any cytotoxic chemotherapy or immunotherapy within the past 6 months.
- History of bone marrow transplantation.
- History of any solid organ transplant (renal, cardiac, liver, lung) requiring immunosuppressive therapy.
- Females who are pregnant or breast feeding.
- Inability to undergo radiotherapy for any other medical or cognitive issues.
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04466683
Start Date
August 28 2020
End Date
December 31 2025
Last Update
March 21 2025
Active Locations (7)
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1
Boca Raton Regional Hospital Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
2
Miami Cancer Institute
Miami, Florida, United States, 33176
3
Loyola University Chicago
Maywood, Illinois, United States, 60153
4
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202