Low Dose Radiotherapy for COVID-19 Pneumonitis

Study Overview
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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.

Official Title
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Low Dose Radiotherapy as Antinflammatory Treatment for COVID-19 Pneumonitis

Conditions
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Covid19

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years. COVID19 + confirmed by PCR. Thoracic imaging study (chest X-ray, chest CT or PET-CT), compatible with lung involvement. Phase II or lung phase without any improvement with pharmacological treatment. Phase III or hyper-inflammatory phase without any improvement with pharmacological treatment Poor clinical and functional respiratory evolution: > 30 breaths / minute, SpO2 <93%, PaO2 / FiO2 <300. D-dimer> 1000 ng / mL or rising, ferritin> 1000 ng / mL, PCR> 10 mg / dL or double than before. Exclusion Criteria: 1. Severe comorbidities that could hamper the radiation treatment.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br> | Radiation: Radiotherapy<br>* Low-dose radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological response | Radiological results: Radiological worsening, improvement or without significant changes | 3 days after low dose radiation | 
| Radiological response | Radiological results: Radiological worsening, improvement or without significant changes | 7 days after low dose radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of respiratory symptoms | Remission of respiratory symptoms | up to 6 months | 
| SPO2 and PaO2/FiO2 | Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen | 7 days | 
| Adverse events | Occurrence and grade of CTCAE 5.0 adverse events | 1 year | 
| Hospitalization | Duration of hospitalization | 3 months | 
| Overall survival | Overall survival | 1 month | 
| Ferritin value | ferritin value (ng/mL) | 1 day after low dose radiation | 
| Ferritin value | ferritin value (ng/mL) | 2 days after low dose radiation | 
| Ferritin value | ferritin value (ng/mL) | 3 days after low dose radiation | 
| blood cell count | blood cell count (unit/L) | 1 day after low dose radiation | 
| blood cell count | blood cell count (unit/L) | 2 days after low dose radiation | 
| blood cell count | blood cell count (unit/L) | 3 days after low dose radiation | 
| C-reactive protein | C-reactive protein (mg/dl) | 1 day after low dose radiation | 
| C-reactive protein | C-reactive protein (mg/dl) | 2 days after low dose radiation | 
| C-reactive protein | C-reactive protein (mg/dl) | 3 days after low dose radiation | 
| D-dimer | D-dimer (ng/ml) | 1 day after low dose radiation | 
| D-dimer | D-dimer (ng/ml) | 2 days after low dose radiation | 
| D-dimer | D-dimer (ng/ml) | 3 days after low dose radiation | 
| LDH levels | LDH levels (UI/L) | 1 day after low dose radiation | 
| LDH levels | LDH levels (UI/L) | 2 days after low dose radiation | 
| LDH levels | LDH levels (UI/L) | 3 days after low dose radiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Antiinflammatory, Pneumonitis