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.

Recruiting
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.
An experimental group receiving radiotherapy

Device: ventilatory support with oxygen therapy
Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
An experimental group receiving radiotherapy

Drug: Lopinavir/ritonavir
100/400 mg/12h; 7-10 days
An experimental group receiving radiotherapy
Other Name: Kaletra

Drug: Hydroxychloroquine
200 mg/12h
An experimental group receiving radiotherapy
Other Name: Dolquine

Drug: Azithromycin
500 mg/24h, 3 days
An experimental group receiving radiotherapy

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
An experimental group receiving radiotherapy

Drug: Low molecular weight heparin
prophylactic doses
An experimental group receiving radiotherapy

Drug: Corticosteroid injection
250mg x 3 boluses
An experimental group receiving radiotherapy
Other Name: Urbason

Drug: Tocilizumab
600mg single dose
An experimental group receiving radiotherapy

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 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
All
Eligibility Age
Minimum: 18 Years~Maximum: 120 Years
Countries
Spain
Contacts

Elena Moreno Olmedo, MD
+34 914445300
elena.moreno@genesiscare.es

Escarlata López Ramírez, MD, PhD
escarlata.lopez@genesiscare.es

Escarlata López Ramírez, MD, PhD
Principal Investigator
Fundacion GenesisCare

Fundacion GenesisCare
Hospital La Milagrosa
Hospital Vithas Valencia Consuelo
NCT Number
Keywords
Low Dose Radiotherapy
COVID19 pneumonia
Anti-inflammatory effects
Acute Respiratory Distress Syndrome (ARDS)
MeSH Terms
Pneumonia, Viral
Pneumonia
Ritonavir
Lopinavir
Azithromycin
Hydroxychloroquine
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Heparin
Heparin, Low-Molecular-Weight
Dalteparin