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

Phase 1

• Conditions: COVID-19 Pneumonitis

• Registration Number: NCT04493294
• Lead Sponsor: International Geriatric Radiotherapy Group

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Last Update Submitted: 2020-07-29
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Study Start: 2020-11
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mortality rate	One year	Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data

Secondary Outcome Measures

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