COVID-19 and low-dose radiation therapy.
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ABSTRACT:
SUBMITTER: Dunlap NE
PROVIDER: S-EPMC8429076 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The coronavirus disease-2019 (COVID-19) pandemic caused by SARS-CoV-2 has exacted an enormous toll on healthcare systems worldwide. The cytokine storm that follows pulmonary infection is causally linked to respiratory compromise and mortality in the majority of patients. The sparsity of viable treatment options for this viral infection and the sequelae of pulmonary complications have fueled the quest for new therapeutic considerations. One such option, the long-forgotten idea of using low-dose radiation therapy, has recently found renewed interest in many academic centers. We outline the scientific and logistical rationale for consideration of this option and the mechanistic underpinnings of any potential therapeutic value, particularly as viewed from an immunological perspective. We also discuss the preliminary and/or published results of prospective trials examining low-dose radiation therapy for COVID-19.
| S-EPMC7717342 | biostudies-literature
Project description:The limited impact of treatments for COVID-19 has stimulated several phase 1 clinical trials of whole-lung low-dose radiation therapy (LDRT; 0.3-1.5 Gy) that are now progressing to phase 2 randomized trials worldwide. This novel but unconventional use of radiation to treat COVID-19 prompted the National Cancer Institute, National Council on Radiation Protection and Measurements and National Institute of Allergy and Infectious Diseases to convene a workshop involving a diverse group of experts in radiation oncology, radiobiology, virology, immunology, radiation protection and public health policy. The workshop was held to discuss the mechanistic underpinnings, rationale, and preclinical and emerging clinical studies, and to develop a general framework for use in clinical studies. Without refuting or endorsing LDRT as a treatment for COVID-19, the purpose of the workshop and this review is to provide guidance to clinicians and researchers who plan to conduct preclinical and clinical studies, given the limited available evidence on its safety and efficacy.
| S-EPMC8009137 | biostudies-literature
Project description:ObjectivesThe World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a pilot trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19.MethodsFrom June to Aug 2020, we enrolled 10 patients with COVID-19 having moderate to severe risk disease [National Early Warning Score (NEWS) of ≥5]. Patients were treated as per the standard COVID-19 management guidelines along with LDRT to both lungs with a dose of 70cGy in single fraction. Response assessment was done based on the clinical parameters using the NEWS.ResultsAll patients completed the prescribed treatment. Nine patients had complete clinical recovery mostly within a period ranging from 3 to 7 days. One patient, who was a known hypertensive, showed clinical deterioration and died 24 days after LDRT. No patients showed the signs of acute radiation toxicity.ConclusionThe results of our pilot study suggest that LDRT is feasible in COVID-19 patients having moderate to severe disease. Its clinical efficacy may be tested by conducting randomized controlled trials.Advances in knowledgeLDRT has shown promising results in COVID-19 pneumonia and should be researched further through randomized controlled trials.
| S-EPMC9328067 | biostudies-literature
Project description:Background and purposeThe objective of this work is to evaluate the risk of carcinogenesis of low dose ionizing radiation therapy (LDRT), for treatment of immune-related pneumonia following COVID-19 infection, through the estimation of effective dose and the lifetime attributable risk of cancer (LAR).Material and methodsLDRT treatment was planned in male and female computational phantoms. Equivalent doses in organs were estimated using both treatment planning system calculations and a peripheral dose model (based on ionization chamber measurements). Skin dose was estimated using radiochromic films. Later, effective dose and LAR were calculated following radiation protection procedures.ResultsEquivalent doses to organs per unit of prescription dose range from 10 mSv/cGy to 0.0051 mSv/cGy. Effective doses range from 204 mSv to 426 mSv, for prescription doses ranging from 50 cGy to 100 cGy. Total LAR for a prescription dose of 50 cGy ranges from 1.7 to 0.29% for male and from 4.9 to 0.54% for female, for ages ranging from 20 to 80 years old.ConclusionsThe organs that mainly contribute to risk are lung and breast. Risk for out-of-field organs is low, less than 0.06 cases per 10000. Female LAR is on average 2.2 times that of a male of the same age. Effective doses are of the same order of magnitude as the higher-dose interventional radiology techniques. For a 60 year-old male, LAR is 8 times that from a cardiac CT, when prescription dose is 50 cGy.
| S-EPMC7553901 | biostudies-literature
Project description:In the current dismal situation of the COVID-19 pandemic, effective management of patients with pneumonia and acute respiratory distress syndrome is of vital importance. Due to the current lack of effective pharmacological concepts, this situation has caused interest in (re)considering historical reports on the treatment of patients with low-dose radiation therapy for pneumonia. Although these historical reports are of low-level evidence per se, hampering recommendations for decision-making in the clinical setting, they indicate effectiveness in the dose range between 0.3 and 1?Gy, similar to more recent dose concepts in the treatment of acute and chronic inflammatory/degenerative benign diseases with, e.g., a single dose per fraction of 0.5?Gy. This concise review aims to critically review the evidence for low-dose radiation treatment of COVID-19 pneumopathy and discuss whether it is worth investigating in the present clinical situation.
| S-EPMC7211051 | biostudies-literature
Project description:PurposeCurrent treatments for coronavirus disease 2019 (COVID-19) lung disease have limited efficacy. Low-dose radiation therapy (LDRT) has received both interest and criticism as a potential treatment for this condition. In this qualitative study we explored clinicians' perspectives to identify barriers to testing LDRT in clinical trials and implementing it in clinical practice.Methods and materialsSemistructured interviews were undertaken with 6 clinicians from 3 medical disciplines. Interviews were recorded, transcribed verbatim, and analyzed thematically, using a framework approach. Common themes regarding barriers to using LDRT for COVID-19 lung disease were identified from the data.ResultsThree categories of barriers emerged: (1) the potential to do harm to the patient, including difficulty in predicting harm and lack of existing data to inform quantification of risks; (2) the feasibility of trialing this novel treatment strategy in the clinical setting, in particular trial design and recruitment, patient selection and buy-in from relevant clinician groups; and (3) the logistics of delivering the treatment, in particular risks of transmission to other patients and resources required for patient transfer.ConclusionsThis study identified several barriers that may impede the evaluation and subsequent implementation of LDRT as a treatment for COVID-19 lung disease, from the perspectives of clinicians in 3 relevant specialties. By documenting and articulating these concerns, we hope to enhance discussion of why these barriers exist, and enable them to be addressed in a proactive manner to facilitate research into the potential benefits of radiation treatment for patients with COVID-19 lung disease going forward.
| S-EPMC7726525 | biostudies-literature
Project description:PurposeThe morbidity and mortality of patients requiring mechanical ventilation for coronavirus disease 2019 (COVID-19) pneumonia is considerable. We studied the use of whole-lung low-dose radiation therapy (LDRT) in this patient cohort.Methods and materialsPatients admitted to the intensive care unit and requiring mechanical ventilation for COVID-19 pneumonia were included in this randomized double-blind study. Patients were randomized to 1 Gy whole-lung LDRT or sham irradiation (sham-RT). Treatment group allocation was concealed from patients and intensive care unit clinicians, who treated patients according to the current standard of care. Patients were followed for the primary endpoint of ventilator-free days at day 15 postintervention. Secondary endpoints included overall survival, as well as changes in oxygenation and inflammatory markers.ResultsTwenty-two patients were randomized to either whole-lung LDRT or sham-RT between November and December 2020. Patients were generally elderly and comorbid, with a median age of 75 years in both arms. No difference in 15-day ventilator-free days was observed between groups (P = 1.00), with a median of 0 days (range, 0-9) in the LDRT arm and 0 days (range, 0-13) in the sham-RT arm. Overall survival at 28 days was identical at 63.6% (95% confidence interval, 40.7%-99.5%) in both arms (P = .69). Apart from a more pronounced reduction in lymphocyte counts after LDRT (P < .01), analyses of secondary endpoints revealed no significant differences between the groups.ConclusionsWhole-lung LDRT failed to improve clinical outcomes in critically ill patients requiring mechanical ventilation for COVID-19 pneumonia.
| S-EPMC7932873 | biostudies-literature
Project description:This study aimed to establish an efficient planning technique for low dose whole lung treatment that can be implemented rapidly and safely. The treatment technique developed here relied only on chest radiograph and a simple empirical monitor unit calculation formula. The 3D dose calculation in real patient anatomy, including both nonCOVID and COVID-19 patients, which took into account tissue heterogeneity showed that the dose delivered to lungs had reasonable uniformity even with this simple and quick setup.
| S-EPMC7550039 | biostudies-literature
Project description:Physicians and scientists around the world are aggressively attempting to develop effective treatment strategies. The treatment goal is to reduce the fatality rate in 15% to 20% of individuals infected with SARS-CoV-2 who develop severe inflammatory conditions that can lead to pneumonia, and acute respiratory distress syndrome. These conditions are major causes of death in these patients. Convalescent plasma (CP) collected from patients recovered from the novel corona virus disease (COVID-19) has been considered as an effective treatment method for COVID-19. Moreover, low-dose radiation therapy (LDRT) for COVID-19 pneumonia was historically used to treat pneumonia during the first half of the 20th century. The concept of LDRT for COVID-19 pneumonia was first introduced in March 2020. Later scientists from Canada, Spain, United States, Germany and France also confirmed the potential efficacy of LDRT for treatment of COVID-19 pneumonia. The rationale behind introducing LDRT as an effective treatment method for pneumonia in COVID-19 patients is not only due to its anti-inflammatory effect, but also in optimization of the activity of the immune system. Moreover, LDRT, unlike other treatment methods such as antiviral drugs, does not have the key disadvantage of exerting a significant selective pressure on the SARS-CoV-2 virus and hence does not lead to evolution of the virus through mutations. Given these considerations, we believe that a hybrid treatment including both CP and LDRT can trigger synergistic responses that will help healthcare providers in mitigating today's COVID-19 pandemic.
| S-EPMC7416097 | biostudies-literature
Project description:Purpose/Objective(s) 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. Recent work has indicated a potential therapeutic window for treatment to prevent ventilator-dependence thereby reducing mortality. PREVENT is an ongoing prospective multicenter Phase II randomized controlled trial where patients hospitalized with COVID-19 pneumonia are randomized to ultra-low dose radiation therapy (RT) versus control. This study is registered at clinicaltrials.gov, NCT04466683. The following is a description of the inpatient onboarding process of the center contributing the largest number of patients to this trial. Materials/Methods COVID-19 hospital admissions from the previous day were attained by the clinical research manager each morning, screened for eligibility, and then sent to the designated radiation oncologist who further delineated from this list. Common exclusion criteria were: 1. Oxygen saturation > 96% on room air, 2. Age < 50, 3. > 9 days from initial COVID-19 symptomatology. From this list, HIPAA-compliant text message contact was made with infectious disease, critical care, and nursing staff with reciprocal discussion of the trial protocol and approval for consulting the patient. Subsequently, a virtual consult was made with the patient, with witnessed informed consent obtained via telephone and in person by our research associate. Patients randomized to RT were treated within 24 hours of consent. Simulation and treatment were 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. On-site dose calculation was performed by physics, after which the radiation oncologist approved the fields prior to treatment delivery. Simulation and treatment were performed without a computer plan; therapists underwent several practice sessions prior to treating patients on trial. 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 research staff member nor radiation oncology clinical team member 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. Despite the procedural hurdles of conducting a trial in the midst of a pandemic, the combination of recruitment efficiency (> 2 patients/week) and safety to the research and clinical teams (no COVID-19 infections) of this protocol has allowed for the PREVENT trial to make substantial progress in meeting recruitment goals (n = 100). This onboarding process serves as a model in conducting recruitment of COVID-19 patients for clinical trials, and is worthy of emulation at additional centers.
| S-EPMC8536240 | biostudies-literature