Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)COVID-RT-01NCT04598581
Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), COVID-19
A study testing Low Dose Radiation Therapy (LD-RT) in people with Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
- What is being tested?
- Low Dose Radiation Therapy (LD-RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Nov 2020to 9 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Radiooncology, University Hospital Basel
Basel, 4031
About this study
Official title: 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).
Read the 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).
- Being tested
- Low Dose Radiation Therapy (LD-RT), Sham irradiation
- Keywords
- Low dose radiation therapy (LD-RT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Radiation Therapy (LD-RT)Radiation
Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
Sham irradiationOther
Sham irradiation
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Radiation Therapy (LD-RT) | Active comparator | Not described Receives: Radiation: Low Dose Radiation Therapy (LD-RT) |
| Sham irradiation | Sham comparator | Not described Receives: Other: Sham irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days (VFD)
Ventilator free days (VFD)
Measured: at day 15 after LD-RT
Secondary outcomes (5)
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)
Measured: at day 5, 10, 15, 28 after LD-RT
Overall mortality
Overall mortality
Measured: at day 15 and 28 after LD-RT
Change in levels of ferritin (ng/ml)
Change in levels of ferritin (ng/ml)
Measured: up to day 15 after LD-RT
Change in levels of c-reactive protein (mg/l)
Change in levels of c-reactive protein (mg/l)
Measured: up to day 15 after LD-RT
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)
Measured: up to day 15 after LD-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start2 Nov 2020
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandros Papachristofilou, Dr. med., Principal investigator, Department of Radiooncology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598581
- Sponsor's protocol ID
- 2020-02047qu20Papachristofilou
- Acronym
- COVID-RT-01
- Status last verified
- Apr 2021
- First submitted
- 20 Oct 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33677049
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT04598581
- Acronym / sponsor ID
- COVID-RT-01 / 2020-02047qu20Papachristofilou
- Keywords
- Low dose radiation therapy (LD-RT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Radiation Therapy (LD-RT) | Active comparator | Radiation: Low Dose Radiation Therapy (LD-RT) |
| Sham irradiation | Sham comparator | Other: Sham irradiation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Radiation Therapy (LD-RT)Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray | Radiation | Low Dose Radiation Therapy (LD-RT) |
| Sham irradiationSham irradiation | Other | Sham irradiation |
Primary outcome
Ventilator free days (VFD)
Time frame: at day 15 after LD-RT
Ventilator free days (VFD)
5 secondary outcomes
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
Overall mortality
Time frame: 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 c-reactive protein (mg/l)
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)
Time frame: up to day 15 after LD-RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Results publication: PubMed 33677049Papachristofilou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros Papachristofilou, Dr. med. principal investigator
Department of Radiooncology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Radiation Therapy (LD-RT) in people with Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator free days (VFD) (time frame: at day 15 after LD-RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.