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

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

— COVID-RT-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598581
• Other study ID #: 2020-02047qu20Papachristofilou
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to analyse the efficacy of LD-RT for treatment of Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 9, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Sham irradiation
Sham irradiation

Locations

Country	Name	City	State
Switzerland	Department of Radiooncology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free days (VFD)	Ventilator free days (VFD)	at day 15 after LD-RT
Secondary	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
Secondary	Overall mortality	Overall mortality	at day 15 and 28 after LD-RT
Secondary	Change in levels of ferritin (ng/ml)	Change in levels of ferritin (ng/ml)	up to day 15 after LD-RT
Secondary	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
Secondary	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