Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
Primary Purpose
COVID-19 Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Low Dose Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Both sexes
- Age > 18 years
- Laboratory confirmation of SARS-CoV-2 infection
- Acute Respiratory Distress Syndrome in any degree with a hospital treatment requirement.
Exclusion Criteria:
- Patients who do not agree to receive the treatment
- Sepsis data
- Hemodynamic instability
Sites / Locations
- Social Secure Mexican Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Not radiotherapy
Radiotherapy
Arm Description
control group
patientis with treatment with radiotherapy 1 Gy to Whole lung.
Outcomes
Primary Outcome Measures
Clinical improvement
improvement of oxygen saturation
Secondary Outcome Measures
improvement of laboratory and imaging parameters
improvement in acute phase reactants and simple tomography
Full Information
NCT ID
NCT04534790
First Posted
August 5, 2020
Last Updated
February 8, 2021
Sponsor
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT04534790
Brief Title
Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
Official Title
Randomized Trial, Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
January 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are several clinical studies that mention the benefits of treatment with low-dose radiation therapy to patients with COVID 19, so this study protocol will be started to determine if there is clinical improvement with treatment and low-dose radiation therapy. to all the lung.
Detailed Description
Until now, multiple studies with antibiotics and monoclonal antibodies have been used to try to stop this infection, however, the studies have not been conclusive about the real benefit of these drugs, so the search for other alternatives has been an obligation for doctors in all the world. For this reason, it was proposed to carry out a treatment with radiotherapy to the lung based on studies published in the middle of the last century.
In the studies where radiation therapy was given to the lung in cases of infections in the 1930s and 1940s, the most important and with the largest number of patients are the studies by Powel, Scott, Rosseasuy and Openheimer, where together they were treated 594 patients with viral and bacterial infections, obtaining a cure in a total of 524 patients, that is, an 88% chance of cure with this treatment in an average of 7 days.
Treatment with low doses of total lung radiotherapy has not only been used in the treatment of pneumonia in 1930-1940, it has also been used recently in other pathologies such as metaplasia with myeloid myelofibrosis, where they are treated with 1 Gy to both lungs and there is a significant improvement in hypoxia, as well as edema within the first 72 hrs. without presenting side effects due to the treatment at low doses of radiotherapy, control studies were also carried out where it was shown that the low dose of Lung radiotherapy is safe and effective, these studies show that low doses of radiotherapy are safe for patients since it does not generate serious side effects that put the patient's health at risk.
These results are similar to the results obtained in one of the few studies of low-dose total lung radiotherapy in patients with COVID-19, which was performed at Emory University Hospital in Atlanta, where 5 patients with pneumonia, positive for COVID 19 that required supplemental oxygen to which they were given a treatment with radiotherapy 1.5 Gy single dose, at 24 hrs., 4 of the patients rapidly improved clinically, recovering in an average of 1.5 days (range 3 to 96 hrs.). Subsequent imaging and laboratory studies confirmed that low doses of radiation therapy are effective and safe in reducing the symptoms produced by COVID 19.
Recently at the University of Teran in Israel the results of their study were also published, which recruited 5 patients with COVID 19 pneumonia who were oxygen dependent. In this study, a single dose of 0.5 Gy was given, reporting an improvement in 80% of patients and they were discharged from 3 to 7 days.
For which this study was carried out with the objective of determine the anti-inflammatory effect of low-dose total lung radiation therapy in patients with respiratory distress syndrome secondary to covid-19 infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Not radiotherapy
Arm Type
No Intervention
Arm Description
control group
Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
patientis with treatment with radiotherapy 1 Gy to Whole lung.
Intervention Type
Radiation
Intervention Name(s)
Low Dose Radiotherapy
Intervention Description
anti-inflammatory effect with low-dose radiation to the lungs
Primary Outcome Measure Information:
Title
Clinical improvement
Description
improvement of oxygen saturation
Time Frame
7 days
Secondary Outcome Measure Information:
Title
improvement of laboratory and imaging parameters
Description
improvement in acute phase reactants and simple tomography
Time Frame
7 -14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both sexes
Age > 18 years
Laboratory confirmation of SARS-CoV-2 infection
Acute Respiratory Distress Syndrome in any degree with a hospital treatment requirement.
Exclusion Criteria:
Patients who do not agree to receive the treatment
Sepsis data
Hemodynamic instability
Facility Information:
Facility Name
Social Secure Mexican Institute
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37160
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
We'll reach out to this number within 24 hrs