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

Overview

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

Full Title of Study: “Low Dose Radiation Therapy for Severe-Acute-Respiratory-Syndrome-Coronavirus-2 (SARS-CoV-2)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: April 9, 2021

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

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

Arms, Groups and Cohorts

  • Active Comparator: Low Dose Radiation Therapy (LD-RT)
  • Sham Comparator: Sham irradiation

Clinical Trial Outcome Measures

Primary Measures

  • Ventilator free days (VFD)
    • Time Frame: at day 15 after LD-RT
    • Ventilator free days (VFD)

Secondary Measures

  • 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
    • Change in pulmonary function, measured as relative change (%) from baseline in oxygenation index (PaO2 / FiO2)
  • Overall mortality
    • Time Frame: at day 15 and 28 after LD-RT
    • Overall mortality
  • Change in levels of ferritin (ng/ml)
    • Time Frame: up to day 15 after LD-RT
    • Change in levels of ferritin (ng/ml)
  • Change in levels of c-reactive protein (mg/l)
    • Time Frame: 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)
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexandros Papachristofilou, Dr. med., Principal Investigator, Department of Radiooncology, University Hospital Basel

Citations Reporting on Results

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 Oncol Biol Phys. 2021 Mar 5. pii: S0360-3016(21)00239-X. doi: 10.1016/j.ijrobp.2021.02.054. [Epub ahead of print]

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.