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

NCT ID: NCT04414293

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-12-31

Brief Summary

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

Detailed 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.

Conditions

COVID; Pneumonia, Viral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All the patients will be treated with low dose lung radiation

Group Type: EXPERIMENTAL

Lung Low Dose Radiation

Intervention Type: RADIATION

The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.

Interventions

Lung Low Dose Radiation

The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Provincial de Castellon

OTHER

Sponsor Role: lead

Responsible Party

Carlos Ferrer Albiach

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Ferrer Albiach, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Provincial de Castellon

Locations

Hospital Provincial de Castellon

Castellon, Castellon, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco Garcia Piñón, MSc

Role: CONTACT

francisco.garpi@hospitalprovincial.es

964354458

Facility Contacts

FRANCISCO GARCIA PINON, MSc

Role: primary

964354458

Other Identifiers

FHPCS-20-001

Identifier Type: -

Identifier Source: org_study_id