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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)

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

Intervention / Treatment
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* Radiation: Low Dose Radiation Therapy (LD-RT)
* Other: Sham irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Dose Radiation Therapy (LD-RT)<br> | Radiation: Low Dose Radiation Therapy (LD-RT)<br>* Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray<br>|
| Sham Comparator: Sham irradiation<br> | Other: Sham irradiation<br>* Sham irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days (VFD) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low dose radiation therapy (LD-RT)