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 <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
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Del Mar
Barcelona, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, Spain
ANGEL MONTERO, Md, PhD
+34667767601
angel.monteroluis@gmail.com