Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis (COVRTE-19)
Primary Purpose
COVID, Pneumonia, Viral
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lung Low Dose Radiation
Sponsored by
About this trial
This is an interventional treatment trial for COVID focused on measuring covid-19 pneumonia, Low dose Radiotherapy
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
Sites / Locations
- Hospital Provincial de CastellonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All the patients will be treated with low dose lung radiation
Outcomes
Primary Outcome Measures
blood oxygen saturation level
Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
Torax X-ray
radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
Secondary Outcome Measures
Hospitalization
number of days of hospital stay.
days free of assisted mechanical respiration
Number of days free of assisted mechanical respiration.
Mortality
number of deaths
Full Information
NCT ID
NCT04414293
First Posted
June 1, 2020
Last Updated
February 12, 2021
Sponsor
Hospital Provincial de Castellon
1. Study Identification
Unique Protocol Identification Number
NCT04414293
Brief Title
Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
Acronym
COVRTE-19
Official Title
Phase II Study of Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Provincial de Castellon
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Pneumonia, Viral
Keywords
covid-19 pneumonia, Low dose Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All the patients will be treated with low dose lung radiation
Intervention Type
Radiation
Intervention Name(s)
Lung Low Dose Radiation
Intervention Description
The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
Primary Outcome Measure Information:
Title
blood oxygen saturation level
Description
Clinical improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment, measured as blood oxygen saturation levels
Time Frame
48 hours
Title
Torax X-ray
Description
radiological improvement of respiratory symptoms due to COVID-19 pneumonia after the treatment.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Hospitalization
Description
number of days of hospital stay.
Time Frame
2 months
Title
days free of assisted mechanical respiration
Description
Number of days free of assisted mechanical respiration.
Time Frame
3 month
Title
Mortality
Description
number of deaths
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Garcia Piñón, MSc
Phone
964354458
Email
francisco.garpi@hospitalprovincial.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Ferrer Albiach, MD
Organizational Affiliation
Hospital Provincial de Castellon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Provincial de Castellon
City
Castellón De La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCISCO GARCIA PINON, MSc
Phone
964354458
First Name & Middle Initial & Last Name & Degree
Carlos Ferrer Albiach, MD
12. IPD Sharing Statement
Learn more about this trial
Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis
We'll reach out to this number within 24 hrs