Official Title
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
Brief Summary

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.

Detailed Description

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.

Recruiting
Pneumonia, Viral

Radiation: Low-dose radiotherapy
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
Experimental group

Drug: Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Control group
Experimental group
Other Name: Dolquine

Drug: Ritonavir/lopinavir
400/100 mg/12h for 7-10 days
Control group
Experimental group
Other Name: Kaletra

Drug: Tocilizumab Injection [Actemra]
600 mg/day for 1-2 doses
Control group
Experimental group
Other Name: Actemra

Drug: Azithromycin
500 mg/24h for 3 days
Control group
Experimental group

Drug: Corticosteroid
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
Control group
Experimental group

Drug: Low molecular weight heparin
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Control group
Experimental group

Device: Oxygen supply
Oxygen
Control group
Experimental group

Eligibility Criteria

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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Countries
Spain
Contacts

ANGEL MONTERO, Md, PhD
+34667767601
angel.monteroluis@gmail.com

Angel Montero, MD, PhD
Principal Investigator
Hospital Universitario Madrid Sanchinarro

~

Manel Algara, MD, PhD
Principal Investigator
Hospital del Mar

~

Merirxell Arenas, MD, PhD
Principal Investigator
Hospital Universitario Sant Joan de Reus

Grupo de Investigación Clínica en Oncología Radioterapia
Hospital Universitario Madrid Sanchinarro
Hospital del Mar
Hospital Universitari Sant Joan de Reus
NCT Number
Keywords
COVID 19
RADIATION
Anti-inflammatory effects
MeSH Terms
Pneumonia, Viral
Pneumonia
Ritonavir
Lopinavir
Azithromycin
Hydroxychloroquine
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin