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

COVID-19 Pneumonitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04493294
• Other study ID #: IGRG01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: International Geriatric Radiotherapy Group
• Contact: Nam p Nguyen, MD
• Phone: 202-865-1421
• Email: namphong.nguyen[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Pneumonitis
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
International Geriatric Radiotherapy Group	Brigitta G. Baumert

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Comparing mortality rate of the whole group of patients treated with low dose whole lung radiotherapy with historical data	One year
Secondary	Mortality rate	Comparison mortality rate of different ethnic groups treated with whole lung radiotherapy for COVID-19 pneumonia	One year
Secondary	Duration of hospitalization	Duration of hospitalization for the whole group and different groups with or without oxygen requirement	One year
Secondary	Time to recovery	Ordinal scale at the time of radiotherapy and 28 days later	One month
Secondary	Oxygen saturation rate	Correlation between oxygen saturation rate and ordinal scale at different times following radiotherapy	One year
Secondary	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