In this prospective and descriptive cohort study conducted at the Sant Joan University Hospital, Reus, Spain, we enrolled 46 hospitalized patients who tested positive for SARS-CoV-2 by RT-PCR from the IPACOVID clinical trial (NCT04380818) between June 2020 and February 2021. Inclusion criteria included patients with a positive COVID-19 diagnosis with moderate to severe pneumonia confirmed by chest X-ray requiring hospitalization with supplemental O2, who, due to comorbidities or general status, were not eligible for admission to the intensive care unit (ICU). Patients were treated with LDRT, specifically a single dose of 0.5 Gy to the whole thorax, during the acute phase of COVID-19 infection. The detailed protocol regarding the radiotherapy plan and sample collection has been previously published [11 (link)]. The present study was approved by the Institutional Review Board (IRB) of the Sant Joan University Hospital in Reus. Written informed consent was obtained from each participant in accordance with the recommendations established in the latest version of the Declaration of Helsinki, Fortaleza 2013.
The primary endpoint of the present study was to study baseline SARS-CoV-2 serum viral load, whether as a continuous or a categorical variable, and its gene profiling among patients in an LDRT-treated cohort. In this line, we wanted to analyze if pre-treatment serum viral load could be used as a predictor of infection mortality, either on its own or in combination with other relevant clinical and laboratory parameters that have been previously related to worse outcomes. The secondary aim was to investigate the direct association between SARS-CoV-2 serum viral load and the severity score CURB-65 (based on age, urea level, vital signs, and presence of confusion) and of the latter with the inflammatory blood marker interleukin-6 (IL-6). The third objective was to study if serum SARS-CoV-2 viremic individuals presented higher circulating total RNA serum concentration compared to aviremic patients. The fourth aim was to investigate whether differences were found in the evolution of C-reactive protein (CRP), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH) concentrations throughout the 30-day follow-up of the trial between the serum SARS-CoV-2 positive group and the serum SARS-CoV-2 negative group. Finally, we wanted to examine the correlation between SARS-CoV-2 serum viral load and other COVID-19 severity risk factors.
The primary endpoint of the present study was to study baseline SARS-CoV-2 serum viral load, whether as a continuous or a categorical variable, and its gene profiling among patients in an LDRT-treated cohort. In this line, we wanted to analyze if pre-treatment serum viral load could be used as a predictor of infection mortality, either on its own or in combination with other relevant clinical and laboratory parameters that have been previously related to worse outcomes. The secondary aim was to investigate the direct association between SARS-CoV-2 serum viral load and the severity score CURB-65 (based on age, urea level, vital signs, and presence of confusion) and of the latter with the inflammatory blood marker interleukin-6 (IL-6). The third objective was to study if serum SARS-CoV-2 viremic individuals presented higher circulating total RNA serum concentration compared to aviremic patients. The fourth aim was to investigate whether differences were found in the evolution of C-reactive protein (CRP), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH) concentrations throughout the 30-day follow-up of the trial between the serum SARS-CoV-2 positive group and the serum SARS-CoV-2 negative group. Finally, we wanted to examine the correlation between SARS-CoV-2 serum viral load and other COVID-19 severity risk factors.
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