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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414293
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Ferrer Albiach, Hospital Provincial de Castellon

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


Condition or disease Intervention/treatment Phase
COVID Pneumonia, Viral Radiation: Lung Low Dose Radiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.




Primary Outcome Measures :
  1. blood oxygen saturation level [ Time Frame: 48 hours ]
    Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels

  2. Torax X-ray [ Time Frame: 48 hours ]
    radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 2 months ]
    number of days of hospital stay.

  2. days free of assisted mechanical respiration [ Time Frame: 3 month ]
    Number of days free of assisted mechanical respiration.

  3. Mortality [ Time Frame: 3 months ]
    number of deaths



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414293


Contacts
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Contact: Francisco Garcia Piñón, MSc 964354458 francisco.garpi@hospitalprovincial.es

Locations
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Spain
Hospital Provincial de Castellon
Castellón De La Plana, Castellon, Spain, 12002
Sponsors and Collaborators
Hospital Provincial de Castellon
Investigators
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Principal Investigator: Carlos Ferrer Albiach, MD Hospital Provincial de Castellon
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Responsible Party: Carlos Ferrer Albiach, MD, Hospital Provincial de Castellon
ClinicalTrials.gov Identifier: NCT04414293    
Other Study ID Numbers: FHPCS-20-001
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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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
Keywords provided by Carlos Ferrer Albiach, Hospital Provincial de Castellon:
covid-19 pneumonia
Low dose Radiotherapy
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases