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COVID-19 PneumoniaNCT04534790

Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia

A study testing Low Dose Radiotherapy in people with COVID-19 Pneumonia, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
Low Dose Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMexico
Study dates
24 Jul 2020to 8 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both sexes
  • Age > 18 years
  • Laboratory confirmation of SARS-CoV-2 infection
  • Acute Respiratory Distress Syndrome in any degree with a hospital treatment requirement.

Who cannot join

  • Patients who do not agree to receive the treatment
  • Sepsis data
  • Hemodynamic instability

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Social Secure Mexican Institute

    León, Guanajuato, 37160

Other trials in Mexico

About this study

Official title: Randomized Trial, Anti-inflammatory Effect of Low-Dose Whole-Lung Radiation for COVID-19 Pneumonia

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.

Read the 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.

Being tested
Low Dose Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose RadiotherapyRadiation

    anti-inflammatory effect with low-dose radiation to the lungs

Study groups in NCT04534790
Study groupRoleWhat they receive
Not radiotherapyNo interventioncontrol group
RadiotherapyExperimentalpatientis with treatment with radiotherapy 1 Gy to Whole lung.
Receives: Radiation: Low Dose Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical improvement

    improvement of oxygen saturation

    Measured: 7 days

Secondary outcomes (1)
  1. improvement of laboratory and imaging parameters

    improvement in acute phase reactants and simple tomography

    Measured: 7 -14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start24 Jul 2020
  3. Primary completion12 Dec 2020
  4. Study completion8 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04534790
Sponsor's protocol ID
PI-2020-2858
Status last verified
Feb 2021
First submitted
5 Aug 2020
Last updated
9 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Low Dose Radiotherapy in people with COVID-19 Pneumonia, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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