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.
Radiation: Low-dose radiotherapy
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
Drug: Hydroxychloroquine Sulfate
200 mg/12h for 5 days
Other Name: Dolquine
Drug: Ritonavir/lopinavir
400/100 mg/12h for 7-10 days
Other Name: Kaletra
Drug: Tocilizumab Injection [Actemra]
600 mg/day for 1-2 doses
Other Name: Actemra
Drug: Azithromycin
500 mg/24h for 3 days
Drug: Corticosteroid
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
Drug: Low molecular weight heparin
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
Device: Oxygen supply
Oxygen
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
ANGEL MONTERO, Md, PhD
+34667767601
angel.monteroluis@gmail.com
Angel Montero, MD, PhD
Principal Investigator
Hospital Universitario Madrid Sanchinarro
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Manel Algara, MD, PhD
Principal Investigator
Hospital del Mar
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Merirxell Arenas, MD, PhD
Principal Investigator
Hospital Universitario Sant Joan de Reus