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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-04-09

Brief Summary

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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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Detailed Description

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Information on group allocation will not be disclosed to either the patient or the ICU-staff.

Study Groups

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Low Dose Radiation Therapy (LD-RT)

Group Type ACTIVE_COMPARATOR

Low Dose Radiation Therapy (LD-RT)

Intervention Type RADIATION

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

Sham irradiation

Group Type SHAM_COMPARATOR

Sham irradiation

Intervention Type OTHER

Sham irradiation

Interventions

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Low Dose Radiation Therapy (LD-RT)

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

Intervention Type RADIATION

Sham irradiation

Intervention Type OTHER

Eligibility Criteria

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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