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

Primary Purpose

Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Low Dose Radiation Therapy (LD-RT)
Sham irradiation
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2) focused on measuring Low dose radiation therapy (LD-RT)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiooncology, University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low Dose Radiation Therapy (LD-RT)

Sham irradiation

Arm Description

Outcomes

Primary Outcome Measures

Ventilator free days (VFD)
Ventilator free days (VFD)

Secondary Outcome Measures

Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
Overall mortality
Overall mortality
Change in levels of ferritin (ng/ml)
Change in levels of ferritin (ng/ml)
Change in levels of c-reactive protein (mg/l)
Change in levels of c-reactive protein (mg/l)
Change in levels of white blood cell counts (number of white blood cells per volume of blood)
Change in levels of white blood cell counts (number of white blood cells per volume of blood)

Full Information

First Posted
October 20, 2020
Last Updated
April 14, 2021
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04598581
Brief Title
Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), COVID-19
Acronym
COVID-RT-01
Official Title
Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
Keywords
Low dose radiation therapy (LD-RT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Information on group allocation will not be disclosed to either the patient or the ICU-staff.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Radiation Therapy (LD-RT)
Arm Type
Active Comparator
Arm Title
Sham irradiation
Arm Type
Sham Comparator
Intervention Type
Radiation
Intervention Name(s)
Low Dose Radiation Therapy (LD-RT)
Intervention Description
Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
Intervention Type
Other
Intervention Name(s)
Sham irradiation
Intervention Description
Sham irradiation
Primary Outcome Measure Information:
Title
Ventilator free days (VFD)
Description
Ventilator free days (VFD)
Time Frame
at day 15 after LD-RT
Secondary Outcome Measure Information:
Title
Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
Description
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
Title
Overall mortality
Description
Overall mortality
Time Frame
at day 15 and 28 after LD-RT
Title
Change in levels of ferritin (ng/ml)
Description
Change in levels of ferritin (ng/ml)
Time Frame
up to day 15 after LD-RT
Title
Change in levels of c-reactive protein (mg/l)
Description
Change in levels of c-reactive protein (mg/l)
Time Frame
up to day 15 after LD-RT
Title
Change in levels of white blood cell counts (number of white blood cells per volume of blood)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandros Papachristofilou, Dr. med.
Organizational Affiliation
Department of Radiooncology, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiooncology, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33677049
Citation
Papachristofilou A, Finazzi T, Blum A, Zehnder T, Zellweger N, Lustenberger J, Bauer T, Dott C, Avcu Y, Kohler G, Zimmermann F, Pargger H, Siegemund M. Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Randomized Double-Blind Study. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1274-1282. doi: 10.1016/j.ijrobp.2021.02.054. Epub 2021 Mar 5.
Results Reference
result

Learn more about this trial

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

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