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

Not Applicable

Completed

• Conditions: Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)
• Interventions: Other: Sham irradiation; Radiation: Low Dose Radiation Therapy (LD-RT)

• Registration Number: NCT04598581
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2020-11-02
• Status Verified: 2021-04
• Primary Completion: 2021-04-09
• Study Completion: 2021-04-09
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham irradiation	Sham irradiation	-
Low Dose Radiation Therapy (LD-RT)	Low Dose Radiation Therapy (LD-RT)	-

Primary Outcome Measures

Name	Time	Method
Ventilator free days (VFD)	at day 15 after LD-RT	Ventilator free days (VFD)

Secondary Outcome Measures

Name	Time	Method
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)
Overall mortality	at day 15 and 28 after LD-RT	Overall mortality
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)
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)

Trial Locations

Locations (1)

Department of Radiooncology, University Hospital Basel; 🇨🇭 Basel, Switzerland