Overview
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.
Description
Study design: This is a prospective multicenter study in 2 phases:
- 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.
- 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.
Eligibility
Inclusion Criteria:
- Age >=18 years old
- Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses
- PAFIO2 of less than 300 mmHg or SaFI02 <315 mmHg
- Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition.
- One of the following conditions:
- or IL6 greater than 40
- or PCR> 100mg / l
- D-dimer greater than 1500ng / ml
- Suspected cytokine release syndrome
- Have read the information sheet and signed the informed consent
Exclusion Criteria:
- Age <18 years
- Failure to meet the inclusion criteria
- Leukopenia <1000
- Pregnancy
- Not understanding or refusing the purpose of the study