Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis (COVRTE-19)

H

Hospital Provincial de Castellon

Status

Unknown

Conditions

COVID
Pneumonia, Viral

Treatments

Radiation: Lung Low Dose Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT04414293
FHPCS-20-001

Details and patient eligibility

About

The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response. The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU

Full description

The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19". Beyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment. Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s. The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment. This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.

Enrollment

41 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 65 years old

Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:

  • Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or computed tomography (CT).
  • Acute respiratory failure expressed by PaO2 / FIO2 <300.
  • Lymphopenia ≤0.8 × 109 / L (800 lymphocytes / ml).
  • Patients with ≤8 days from the onset of symptoms.

Exclusion criteria

Patient not consent to participate

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

41 participants in 1 patient group

Treatment
Experimental group
Description:
All the patients will be treated with low dose lung radiation
Treatment:
Radiation: Lung Low Dose Radiation

Trial contacts and locations

0

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Central trial contact

Francisco Garcia Piñón, MSc

Data sourced from clinicaltrials.gov

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