Covid19
Conditions
Keywords
Radiotherapy, Antiinflammatory, Pneumonitis
Brief summary
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.
Interventions
RADIATIONRadiotherapy
Low-dose radiotherapy
Sponsors
Hospital San Carlos, Madrid
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
1\. Severe comorbidities that could hamper the radiation treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological response | 3 days after low dose radiation | Radiological results: Radiological worsening, improvement or without significant changes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPO2 and PaO2/FiO2 | 7 days | Time to SPO2\>94% or PaO2/FiO2 \>350mmHg without oxygen |
| Adverse events | 1 year | Occurrence and grade of CTCAE 5.0 adverse events |
| Hospitalization | 3 months | Duration of hospitalization |
| Overall survival | 1 month | Overall survival |
| Remission of respiratory symptoms | up to 6 months | Remission of respiratory symptoms |
| blood cell count | 1 day after low dose radiation | blood cell count (unit/L) |
| C-reactive protein | 1 day after low dose radiation | C-reactive protein (mg/dl) |
| D-dimer | 1 day after low dose radiation | D-dimer (ng/ml) |
| LDH levels | 1 day after low dose radiation | LDH levels (UI/L) |
| Ferritin value | 1 day after low dose radiation | ferritin value (ng/mL) |
Countries
Spain
Contacts
Primary ContactManuel Gonzalo Vazquez Masedo, MD,PhD
Outcome results
None listed