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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Radiation: Low Dose Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37160
      • Social Secure Mexican Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who do not agree to receive the treatment
2. Sepsis data
3. Hemodynamic instability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Not radiotherapy; control group
Experimental: Radiotherapy; patientis with treatment with radiotherapy 1 Gy to Whole lung.	Radiation: Low Dose Radiotherapy; anti-inflammatory effect with low-dose radiation to the lungs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	improvement of oxygen saturation	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of laboratory and imaging parameters	improvement in acute phase reactants and simple tomography	7 -14 days

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): January 8, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: PI-2020-2858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No