- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04598581
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
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
-
-
-
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)
|
Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
|
SHAM_COMPARATOR: 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.
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.
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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