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

University Hospital, Basel, Switzerland22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Low Dose Radiation Therapy (LD-RT)RADIATION

Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray

Sham irradiationOTHER

Sham irradiation

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Radiooncology, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Ventilator free days (VFD)

Time frame: at day 15 after LD-RT

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

Data from ClinicalTrials.gov

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