NCT04534790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

August 5, 2020

Last Update Submit

February 8, 2021

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement

    improvement of oxygen saturation

    7 days

Secondary Outcomes (1)

  • improvement of laboratory and imaging parameters

    7 -14 days

Study Arms (2)

Not radiotherapy

NO INTERVENTION

control group

Radiotherapy

EXPERIMENTAL

patientis with treatment with radiotherapy 1 Gy to Whole lung.

Radiation: Low Dose Radiotherapy

Interventions

Low Dose RadiotherapyRADIATION

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

Radiotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social Secure Mexican Institute

León, Guanajuato, 37160, Mexico

Location

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD,

Study Record Dates

First Submitted

August 5, 2020

First Posted

September 1, 2020

Study Start

July 24, 2020

Primary Completion

December 12, 2020

Study Completion

January 8, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

ME(1)