Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534790
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2020-08-05
Brief Title:
Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Randomized Trial Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 15 Gy single dose at 24 hrs 4 of the patients rapidly improved clinically recovering in an average of 15 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 05 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
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 patients 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 15 Gy single dose at 24 hrs 4 of the patients rapidly improved clinically recovering in an average of 15 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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None