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

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

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

Study Overview

• Status: Unknown
• Conditions: COVID-19 Pneumonitis
• Intervention / Treatment: Radiation: Low dose whole lung radiotherapy for 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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2; Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: International Geriatric Radiotherapy Group
• Collaborators: Brigitta G. Baumert
• Investigators: Principal Investigator: Brigitta G Baumert, M.D.Ph.D, Institute of Radiation Oncology, Cantonal hospital Graubuenden, Chur, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; pneumonitis; low dose; whole lung radiotherapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: IGRG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There are over 40 people involved in the study, we need their approval before data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No