Official Title
Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers
Brief Summary

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

Detailed Description

The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation
of novel therapies that could potentially mitigate the advanced disease manifestations. In
this context, is proposes a prospective multicenter study. It will include 15 patients, to
assess the feasibility and efficacy of low-dose lung irradiation in COVID-19 pneumonia.

Pneumonia, Viral
Cytokine Storm

Radiation: Ultra-Low-dose radiotherapy

The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.

Device: ventilatory support with oxygen therapy

Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir

Drug: Lopinavir/ritonavir

100/400 mg/12h; 7-10 days
Other Name: Kaletra

Drug: Hydroxychloroquine

200 mg/12h
Other Name: Dolquine

Drug: Azithromycin

500 mg/24h, 3 days

Drug: Piperacillin/tazobactam

4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function

Drug: Low molecular weight heparin

prophylactic doses

Drug: Corticosteroid injection

250mg x 3 boluses
Other Name: Urbason

Drug: Tocilizumab

600mg single dose

Eligibility Criteria

Inclusion Criteria:

1. Age > 18 years-old.

2. Diagnosis of pneumonia due to COVID-19 serologically proven by polymerase chain
reaction (PCR) or highly suspected to be COVID-related.

3. Charlson Comorbidity Index (CCI) less than 6 score.

4. Poor or no response to standard medical treatment, based on:

*% Sat02 <93%

- Oxygen therapy escalation (Understanding from less to more need for support:
Nasal Cannula-NC-; Ventimask -VMK- and VMK with reservoir)

- Pa02 / Fi02 (blood gas analysis) <300 mmHg

- 1 or more inflammatory and immunological analytical parameters such as
lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and
fibrinogen with values above the normal range, except lymphocytes.

- Radiological impairment defined as worsening of TSS throughout admission or score
at admission: TSS> 5 by a diagnostic baseline CT scan.

5. Eastern Cooperative Oncology Group (ECOG) Status < or = 3

6. Life expectancy (LE)> 1 month at hospital admission for COVID-19

7. No previous thoracic RT (relative-individualization criteria) or chemotherapy
(chemoinduced pulmonary toxicity, eg Bleomycin).

8. Verbal information on the procedure, objective and secondary effects, acceptance and
signing of informed consent by the patient or legal guardian.

Exclusion Criteria:

- Failure to meet the inclusion criteria.

- Any uncontrolled intercurrent illness that would put the patient at greater risk or
limit compliance with study requirements in the opinion of the investigator.

- Patients admitted in ICU.

- Refusal of treatment after verbal information.

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: 120 Years

Hospital La Milagrosa, GenesisCare
Madrid, Spain

Hospital Vithas Valencia Consuelo
Valencia, Spain

Escarlata López Ramírez, MD, PhD, Principal Investigator
Fundacion GenesisCare

Fundacion GenesisCare
NCT Number
Low Dose Radiotherapy
COVID19 pneumonia
Anti-inflammatory effects
Acute Respiratory Distress Syndrome (ARDS)
MeSH Terms
Pneumonia, Viral
Cytokine Release Syndrome
Piperacillin, Tazobactam Drug Combination
Heparin, Low-Molecular-Weight