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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Low-dose radiotherapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Severe comorbidities that could hamper the radiation treatment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Gonzalo Vazquez Masedo, MD,PhD | Contact | 913003000 | manuelgonzalo.vazquez@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de OncologÃa Radioterápica. Hospital ClÃnico San Carlos | Recruiting | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |