Low-dose whole thorax radiation therapy for COVID-19 pneumonia: inpatient onboarding process for a randomized controlled trial
Shearwood McClelland 3rd, Amy C Miller, Mark D Williams, Benjamin P Anthony, Arnab Chakravarti, Paul A Anthony, Shearwood McClelland 3rd, Amy C Miller, Mark D Williams, Benjamin P Anthony, Arnab Chakravarti, Paul A Anthony
Abstract
Background: The mortality of the SARS-CoV-2 virus (COVID-19) has been associated with a pulmonary inflammatory response resulting in hypoxemia and rapid clinical decline. PREVENT is an ongoing prospective multicenter Phase II randomized controlled trial where patients hospitalized with COVID-19 pneumonia are randomized to low dose radiation therapy (RT) versus control (clinicaltrials.gov, NCT04466683). We describe the inpatient onboarding process of the center contributing the largest number of patients to this trial.
Materials and methods: COVID-19 hospital admissions were attained by the clinical research manager and radiation oncologist daily. Text message contact was made with infectious disease, critical care, and nursing staff with reciprocal discussion of the trial protocol and approval for virtual consulting of the patient. Witnessed informed consent was obtained first by telephone and later in person. Simulation and treatment (performed without a computer plan) was performed on a linear accelerator with one personal protective equipment-protected therapist moving in and out of the treatment room, and a second therapist manning the console. Following on-site dose calculation by physics, the radiation oncologist approved the fields prior to treatment delivery.
Results: Between August 28, 2020 and October 6, 2020, the first 10 enrolled patients on this multicenter trial were randomized and treated at our institution; no team member (research staff, radiation oncology) contracted COVID-19 while employing this protocol.
Conclusion: This represents the first published protocol to address efficient and safe recruitment of COVID-19 patients for a radiation oncology trial, serving as a model for conducting recruitment of COVID-19 patients for clinical trials.
Keywords: COVID-19 pneumonia; patient recruitment; radiation therapy; randomized controlled trial.
Conflict of interest statement
Conflicts of interest No author has any conflicts of interest.
© 2021 Greater Poland Cancer Centre.
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References
- Sanders J, Monogue M, Jodlowski T, et al. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19) JAMA. 2020;323(18):1824–1836. doi: 10.1001/jama.2020.6019.
- Tian S, Hu W, Niu Li, et al. Pulmonary Pathology of Early-Phase 2019 Novel Coronavirus (COVID-19) Pneumonia in Two Patients With Lung Cancer. J Thorac Oncol. 2020;15(5):700–704. doi: 10.1016/j.jtho.2020.02.010.
- Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. doi: 10.1016/s0140-6736(20)30183-5.
- Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054–1062. doi: 10.1016/s0140-6736(20)30566-3.
- Gong J, Ou J, Qiu X, et al. A Tool for Early Prediction of Severe Coronavirus Disease 2019 (COVID-19): A Multicenter Study Using the Risk Nomogram in Wuhan and Guangdong, China. Clin Infect Dis. 2020;71(15):833–840. doi: 10.1093/cid/ciaa443.
- Richardson S, Hirsch J, Narasimhan M, et al. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020;323(20):2052. doi: 10.1001/jama.2020.6775.
- Oppenheimer A. Roentgen therapy of “virus” pneumonia. Am J Roentgenol Rad Ther. 1943;49:635–638.
- Oppenheimer A. Roentgen therapy of interstitial pneumonia. J Pediatr. 1943;23(5):534–538. doi: 10.1016/s0022-3476(43)80256-0.
- Papachristofilou A, Finazzi T, Blum A, et al. Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Randomized Double-Blind Study. Int J Radiat Oncol Biol Phys. 2021;110(5):1274–1282. doi: 10.1016/j.ijrobp.2021.02.054.
- Dracham CB, Shankar A, Madan R. Radiation induced secondary malignancies: a review article. Radiat Oncol J. 2018;36(2):85–94. doi: 10.3857/roj.2018.00290.
Source: PubMed