Purpose/Objective(s) Low-Dose Radiation Therapy (LD-RT) is an emerging treatment option for patients with COVID-19 related pneumonia. Infectivity of the SARS-CoV-2 virus complicates incorporation of LD-RT into existing radiation oncology clinics. Materials/Methods The first phase I/II trial of LD-RT for COVID-19-related pneumonia implemented novel operational protocols to address risk of infection and respiratory events. Patients were transported from hospital rooms to linear accelerators and treated with 0.5 Gy or 1.5 Gy using pre-planned, two-dimensional treatments prepared using diagnostic x-rays and caliper measurements. Workflows were revised over time to balance infection risks with implementation burden. Results Between April 24 and December 7, 2020, fifty-two patients were enrolled and forty were treated. The end-to-end process comprised 16 distinct teams and > 120 cooperating staff members (> 50 core radiation oncology staff). The trial was operationalized at two hospitals at the onset of the COVID-19 pandemic, prior to vaccine availability. Teams included trial leadership/screening (n > 4), inpatient floor staff (n > 10), clinical trials staff and coordinators (n = 8), transport (n = 2), radiation therapists (n > 20), respiratory therapists (n = 5), radiation nursing (n > 7), ICU nursing (n = 4), rapid response teams (n = 4), medical physics (n > 4), dosimetry (n > 3), infection prevention (n > 3), environmental services (n > 6), security (n = 7), lab personnel (n = 1), and physicians from radiation oncology (n = 7), infectious diseases (n = 2), pulmonary/critical care medicine (n = 2), anesthesia (n = 2), and internal medicine (n > 20) [total > 120]. All non-intubated patients were transported by a multi-disciplinary team, consisting of a physician, nurse, transporter, infection prevention specialist, and (when needed) a respiratory therapist. Treatments occurred after normal clinic hours, were initiated by team huddles, check lists, and included personal protective equipment supervision at multiple time points. Transport routes were 880 to 1760 feet (0.33 miles) one-way, with 1 to 3 elevator banks and required 20-35 minutes for round-trip transport and treatment. Oxygen supplementation in non-intubated patients ranged from 2 to 15 L/min. One intubated patient was transported with a portable ventilator and accompanying ICU staff. There were no code-level events during transport. No patient-facing staff contracted COVID-19 from trial activities. Workflow burden was successfully reduced and protocols relaxed over time with increased staff experience. Conclusion Whole-lung low-dose radiation therapy (LD-RT) for COVID-19-related pneumonia was successfully incorporated into existing workflows at a major academic university. Forty patients were treated with no code-level events, and no staff contracted the virus during eight months of trial accrual. Instructional materials and implementation check lists are provided.
Infection Prevention, Operational Workflows, and Implementation Checklists for Whole-Lung Low-Dose Radiation Therapy (LD-RT) for COVID-19-Related Pneumonia