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Completed

NCT Number: NCT04598581

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

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

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiooncology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dose Radiation Therapy (LD-RT)

Radiation

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

Sham irradiation

Other

Sham irradiation

Primary outcomes

  1. Ventilator free days (VFD)

    Time frame: at day 15 after LD-RT

    Ventilator free days (VFD)

Secondary outcomes

  1. 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)

  2. Overall mortality

    Time frame: at day 15 and 28 after LD-RT

    Overall mortality

  3. Change in levels of ferritin (ng/ml)

    Time frame: up to day 15 after LD-RT

    Change in levels of ferritin (ng/ml)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: COVID-RT-01

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.