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This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Radiation Therapy (LD-RT) | Active Comparator |
| |
| Sham irradiation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Radiation Therapy (LD-RT) | Radiation | Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days (VFD) | Ventilator free days (VFD) | at day 15 after LD-RT |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at day 5, 10, 15, 28 after LD-RT |
| Overall mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandros Papachristofilou, Dr. med. | Department of Radiooncology, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiooncology, University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33677049 | Result | 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. |
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Information on group allocation will not be disclosed to either the patient or the ICU-staff.
| Sham irradiation | Other | Sham irradiation |
|
Overall mortality |
| at day 15 and 28 after LD-RT |
| Change in levels of ferritin (ng/ml) | Change in levels of ferritin (ng/ml) | 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) | 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) | up to day 15 after LD-RT |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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