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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pneumonia, Viral; COVID
• Intervention / Treatment: Radiation: Lung Low Dose Radiation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Garcia Piñón, MSc; Phone Number: 964354458; Email: francisco.garpi@hospitalprovincial.es

Study Locations

• Spain
  • Castellon
    • Castellón De La Plana, Castellon, Spain, 12002
      • Recruiting
      • Hospital Provincial de Castellon
      • Contact: FRANCISCO GARCIA PINON, MSc; Phone Number: 964354458
      • Principal Investigator: Carlos Ferrer Albiach, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All the patients will be treated with low dose lung radiation	Radiation: Lung Low Dose Radiation; The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	number of days of hospital stay.	2 months
days free of assisted mechanical respiration	Number of days free of assisted mechanical respiration.	3 month
Mortality	number of deaths	3 months

Collaborators and Investigators

• Sponsor: Hospital Provincial de Castellon
• Investigators: Principal Investigator: Carlos Ferrer Albiach, MD, Hospital Provincial de Castellon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: covid-19 pneumonia; Low dose Radiotherapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; COVID-19; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: FHPCS-20-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No