Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis
Primary Purpose
COVID-19 Pneumonitis
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonitis focused on measuring COVID-19, pneumonitis, whole lung radiotherapy, low dose
Eligibility Criteria
Inclusion Criteria:
- 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen
Exclusion Criteria:
- Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial
Sites / Locations
Outcomes
Primary Outcome Measures
Mortality rate
Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data
Secondary Outcome Measures
Mortality rate
Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia
Duration of hospitalization
Duration of hospitalization for the whole group and different groups with or without oxygen requirement
Time to recovery
Ordinal scale at the time of radiotherapy and 28 days later
Oxygen saturation rate
Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy
Patient inflammatory status
Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy
Full Information
NCT ID
NCT04493294
First Posted
July 29, 2020
Last Updated
July 29, 2020
Sponsor
International Geriatric Radiotherapy Group
Collaborators
Brigitta G. Baumert
1. Study Identification
Unique Protocol Identification Number
NCT04493294
Brief Title
Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis
Official Title
Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Geriatric Radiotherapy Group
Collaborators
Brigitta G. Baumert
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis
Detailed Description
Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity.
Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate.
Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities.
Discussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonitis
Keywords
COVID-19, pneumonitis, whole lung radiotherapy, low dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Using low dose whole lung radiotherapy to older patients who develop COVID-19 pneumonitis to improve their survival compared to historical data
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis
Intervention Description
Low dose whole lung radiotherapy may decrease the cytokines storm related to the viral infection and may improve survival by decreasing the need for artificial ventilation
Primary Outcome Measure Information:
Title
Mortality rate
Description
Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data
Time Frame
One year
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia
Time Frame
One year
Title
Duration of hospitalization
Description
Duration of hospitalization for the whole group and different groups with or without oxygen requirement
Time Frame
One year
Title
Time to recovery
Description
Ordinal scale at the time of radiotherapy and 28 days later
Time Frame
One month
Title
Oxygen saturation rate
Description
Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy
Time Frame
One year
Title
Patient inflammatory status
Description
Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen
Exclusion Criteria:
Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nam p Nguyen, MD
Phone
202-865-1421
Email
namphong.nguyen@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitta G Baumert, M.D.Ph.D
Organizational Affiliation
Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There are over 40 people involved in the study, we need their approval before data sharing
Citations:
PubMed Identifier
32373721
Citation
Lara PC, Burgos J, Macias D. Low dose lung radiotherapy for COVID-19 pneumonia. The rationale for a cost-effective anti-inflammatory treatment. Clin Transl Radiat Oncol. 2020 Apr 25;23:27-29. doi: 10.1016/j.ctro.2020.04.006. eCollection 2020 Jul.
Results Reference
background
PubMed Identifier
32489696
Citation
Lara PC, Nguyen NP, Macias-Verde D, Burgos-Burgos J, Arenas M, Zamagni A, Vinh-Hung V, Baumert BG, Motta M, Myint AS, Bonet M, Popescu T, Vuong T, Appalanaido GK, Trigo L, Karlsson U, Thariat J. Whole-lung Low Dose Irradiation for SARS-Cov2 Induced Pneumonia in the Geriatric Population: An Old Effective Treatment for a New Disease? Recommendation of the International Geriatric Radiotherapy Group. Aging Dis. 2020 May 9;11(3):489-493. doi: 10.14336/AD.2020.0506. eCollection 2020 May.
Results Reference
background
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Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis
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