Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
Conditions
Keywords
Low dose radiation therapy (LD-RT)
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).
Interventions
RADIATIONLow Dose Radiation Therapy (LD-RT)
Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
OTHERSham irradiation
Sham irradiation
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Information on group allocation will not be disclosed to either the patient or the ICU-staff.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free days (VFD) | at day 15 after LD-RT | Ventilator free days (VFD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2) | at day 5, 10, 15, 28 after LD-RT | Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2) |
| Overall mortality | at day 15 and 28 after LD-RT | Overall mortality |
| Change in levels of ferritin (ng/ml) | up to day 15 after LD-RT | Change in levels of ferritin (ng/ml) |
| Change in levels of c-reactive protein (mg/l) | up to day 15 after LD-RT | 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) | up to day 15 after LD-RT | Change in levels of white blood cell counts (number of white blood cells per volume of blood) |
Countries
Switzerland
Outcome results
None listed