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Low-dose Radiation Therapy in the Management of COVID-19 Pneumonia (LOWRAD-Cov19). Final results of a prospective phase I-II trial.
Sanmamed, Noelia; Alcantara, Pino; Gómez, Sara; Bustos, Ana; Cerezo, Elena; Gaztañaga, Miren; Doval, Anxela; Corona, Juan; Rodriguez, Gabriel; Cabello, Noemi; Duffort, Mercedes; Ortuño, Francisco; de Castro, Javier; López, Amanda; Fuentes, Manuel; Sanz, Alvaro; Vazquez, Manuel.
  • Sanmamed N; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain. Electronic address: noelia.sanmamed@salud.madrid.org.
  • Alcantara P; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Faculty of Medicine. Complutense University of Madrid, Spain.
  • Gómez S; Radiology Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Bustos A; Radiology Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Cerezo E; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Gaztañaga M; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain.
  • Doval A; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Corona J; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Faculty of Medicine. Complutense University of Madrid, Spain.
  • Rodriguez G; Medical Physics Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Cabello N; Internal Medicine Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Duffort M; Internal Medicine Department, Infanta Leonor Hospital, Madrid, Spain.
  • Ortuño F; Intensive Care Unit, Clinico San Carlos Hospital, Madrid, Spain.
  • de Castro J; Intensive Care Unit, Clinico San Carlos Hospital, Madrid, Spain.
  • López A; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain.
  • Fuentes M; Preventive Department, Clinico San Carlos Hospital, Madrid, Spain.
  • Sanz A; Medical Oncology Department, Rio Hortega Hospital, Valladolid, Spain.
  • Vazquez M; Radiation Oncology Department, Clinico San Carlos Hospital, Madrid, Spain; Investigation Institute, Clinico San Carlos Hospital, Madrid, Spain; Faculty of Medicine. Complutense University of Madrid, Spain.
Radiother Oncol ; 171: 25-29, 2022 06.
Article in English | MEDLINE | ID: covidwho-1768476
ABSTRACT
BACKGROUND AND

PURPOSE:

To evaluate the results of low-dose radiation therapy (LD-RT) to lungs in the management of patients with COVID-19 pneumonia. MATERIAL AND

METHODS:

We conducted a prospective phase I-II trial enrolling COVID-19 patients ≥50 years-old, with bilateral lung involvement at imaging study and oxygen requirement (oxygen saturation ≤93% on room air). Patients received 1 Gy to whole lungs in a single fraction. Primary outcome was a radiological response assessed as severity and extension scores at days +3 and +7. Secondary outcomes were toxicity (CTCAE v5.0), days of hospitalization, changes in inflammatory blood parameters (ferritin, lymphocytes, C-reactive protein, d-dimer and LDH) and SatO2/FiO2 index (SAFI), at day +3 and +7. Descriptive analyses were summarized as means with standard deviation (SD) and/or medians with interquartile ranges (IQR). A Wilcoxon sign rank test for paired data was used to assess the CT scores and Chi Square was used to assess for comparison of categorical variables.

RESULTS:

Forty-one patients were included. Median age was 71 (IQR 60-84). Eighteen patients (44%) previously received an anti-COVID treatment (tocilizumab, lopinavir/ritonavir, remdesivir) and thirty-two patients (84%) received steroids during LD-RT. The extension score improved significantly (p = 0.02) on day +7. Mean baseline extension score was 13.7 (SD ± 4.9) with a score of 12.2 (±5.2) at day 3, and 12.4 ± 4.7 at day 7. No differences were found in the severity score. SAFI improved significantly on day +3 and +7 (p < 0.01). Median SAFI on day 0 was 147 (IQR 118-264), 230 (IQR 120-343) on day +3 and 293 (IQR 121-353) on day +7. Significant decrease was found in C-reactive protein on day +7 (p = 0.02) and in lymphocytes counts on day +3 and +7 (p = 0.02). The median number of days in hospital after RT was 11 (range 4-78). With a median follow-up of 60 days after LD-RT, 26 (63%) patients were discharged, 11 (27%) died because of COVID respiratory failure and 4 (10%) died of other causes.

CONCLUSIONS:

LD-RT is a feasible and well-tolerated treatment that could lead to rapid clinical improvement. Large randomized trials would be required to establish the efficacy of LD-RT to treat COVID-19 pneumonia.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Humans / Middle aged Language: English Journal: Radiother Oncol Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Humans / Middle aged Language: English Journal: Radiother Oncol Year: 2022 Document Type: Article