Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), COVID-19 (COVID-RT-01)

April 14, 2021 updated by: University Hospital, Basel, Switzerland

Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)

This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Management of patients with SARS-CoV-2 presents a great challenge in the ongoing pandemic. The inflammatory reaction, evident in the later stages of the disease, is linked with high mortality rates. Pharmaceutical interventions at this stage often do not achieve the desired effects. Low Dose Radiation Therapy (LD-RT) has been utilized for treatment of inflammatory conditions because of its immunomodulatory effects. Thus, LD-RT may be an option in SARS-CoV-2 based on pre-clinical models and early clinical data. This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Radiooncology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of male patients >40 years
  • Age of female patients >50 years
  • Patients with SARS-CoV-2 requiring mechanical ventilation
  • Informed consent obtained by the legal representative of the patient

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Low Dose Radiation Therapy (LD-RT)
Radiation: Low Dose Radiation Therapy (LD-RT)
Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
SHAM_COMPARATOR: Sham irradiation
Other: Sham irradiation
Sham irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator free days (VFD)
Time Frame: at day 15 after LD-RT
Ventilator free days (VFD)
at day 15 after LD-RT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
Time Frame: at day 5, 10, 15, 28 after LD-RT
Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
at day 5, 10, 15, 28 after LD-RT
Overall mortality
Time Frame: at day 15 and 28 after LD-RT
Overall mortality
at day 15 and 28 after LD-RT
Change in levels of ferritin (ng/ml)
Time Frame: up to day 15 after LD-RT
Change in levels of ferritin (ng/ml)
up to day 15 after LD-RT
Change in levels of c-reactive protein (mg/l)
Time Frame: up to day 15 after LD-RT
Change in levels of c-reactive protein (mg/l)
up to day 15 after LD-RT
Change in levels of white blood cell counts (number of white blood cells per volume of blood)
Time Frame: up to day 15 after LD-RT
Change in levels of white blood cell counts (number of white blood cells per volume of blood)
up to day 15 after LD-RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Alexandros Papachristofilou, Dr. med., Department of Radiooncology, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2020

Primary Completion (ACTUAL)

April 9, 2021

Study Completion (ACTUAL)

April 9, 2021

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (ACTUAL)

October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02047qu20Papachristofilou

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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