Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.
Study design: This is a prospective multicenter study in 2 phases: 1. Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued. 2. Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
106
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
200 mg/12h for 5 days
400/100 mg/12h for 7-10 days
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
NOT_YET_RECRUITINGHospital Del Mar
Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario Madrid Sanchinarro
Madrid, Spain
RECRUITINGEfficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%
To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. . In cases of impossibility the SaFiO2 will be determined
Time frame: Day 2 after interventional radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Lung toxicity measured according to CTCAEv5
Time frame: Day 30 and day 90 after interventional radiotherapy
Change of the radiological image
Chest CT
Time frame: Days 7 and day 30 after interventional radiotherapy
Overall mortality
Death of any cause
Time frame: Day 15 and Day 30 after interventional radiotherapy
Measure of pro-inflammatory interleukins
Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of trasforming growth factor (TGF-b)
TGF-β (ng/ml)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of tumor necrosis factor alpha (TNF-a)
TNF-α (pg/ml)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
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600 mg/day for 1-2 doses
500 mg/24h for 3 days
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Oxygen
Determining overexpression of pro-inflammatory selectin
Overexpression of L-, E-, and P-selectin
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Determining cell adhesion molecules (CAMs)
Overexpression of ICAM-1, VCAM
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy
Measure of marker of oxidative stress PON-1
PON-1(paraoxonase and arylesterase activity) (IU/ml)
Time frame: Days 1, day 4 and day 7 after interventional radiotherapy