Low Dose Radiotherapy for COVID-19 Pneumonitis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-09-08

Brief Summary

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SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality.

The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Low-dose radiotherapy

Interventions

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Radiotherapy

Low-dose radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 60 years.
2. COVID19 + confirmed by PCR.
3. Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung involvement.
4. Phase II or lung phase without any improvement with pharmacological treatment.
5. Phase III or hyper-inflammatory phase without any improvement with pharmacological treatment
6. Poor clinical and functional respiratory evolution: \> 30 breaths / minute, SpO2 \<93%, PaO2 / FiO2 \<300.
7. D-dimer\> 1000 ng / mL or rising, ferritin\> 1000 ng / mL, PCR\> 10 mg / dL or double than before.