Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04534790 |
| Other study ID # |
PI-2020-2858 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 24, 2020 |
| Est. completion date |
January 8, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Instituto Mexicano del Seguro Social |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
