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

NCT04414293 | Unknown

• 1 other identifier: FHPCS-20-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

COVID; Pneumonia, Viral

Keywords

covid-19 pneumonia; Low dose Radiotherapy

Outcome Measures

Primary Outcomes (2)

• blood oxygen saturation level

  Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels

  48 hours

• Torax X-ray

  radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.

  48 hours

Secondary Outcomes (3)

• Hospitalization

  2 months

• days free of assisted mechanical respiration

  3 month

• Mortality

  3 months

Study Arms (1)

Treatment

EXPERIMENTAL

All the patients will be treated with low dose lung radiation

Radiation: Lung Low Dose Radiation

Interventions

Lung Low Dose Radiation RADIATION

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

Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient not consent to participate

Sponsors & Collaborators

• Hospital Provincial de Castellon: lead

Study Sites (1)

Hospital Provincial de Castellon

Castellon, Castellon, 12002, Spain

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral

Interventions

Radiation

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Carlos Ferrer Albiach, MD

  Hospital Provincial de Castellon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Garcia Piñón, MSc

CONTACT

964354458; francisco.garpi@hospitalprovincial.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

ES (1)