Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis

Study Overview
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Brief Summary
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Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis

Detailed Description
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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.

Official Title
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Low Dose Whole Lung Radiotherapy for Older Patients With Coronavirus 19 Disease (COVID-19) Pneumonitis: Practical Protocol by the International Geriatric Radiotherapy Group

Conditions
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COVID-19 Pneumonitis

Intervention / Treatment
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* Radiation: Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia | One year | 
| Duration of hospitalization | Duration of hospitalization for the whole group and different groups with or without oxygen requirement | One year | 
| Time to recovery | Ordinal scale at the time of radiotherapy and 28 days later | One month | 
| Oxygen saturation rate | Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy | One year | 
| Patient inflammatory status | Biomarkers for inflammation such as Interleukin 6 will be monitored and correlated with ordinal scale at different times following radiotherapy | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, pneumonitis, whole lung radiotherapy, low dose