Pneumonia, Viral
Conditions
Keywords
COVID 19, RADIATION, Anti-inflammatory effects
Brief summary
Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.
Detailed description
Study design: This is a prospective multicenter study in 2 phases: 1. Exploratory phase. It will include 10 patients, to assess the feasibility and efficacy of low-dose lung irradiation. If a minimum efficiency of 30% is not achieved, the study will not be continued. 2. Comparative phase in two groups, a control group, which will only receive pharmacological treatment, and an experimental one. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm, which will receive low-dose lung irradiation.
Interventions
RADIATIONLow-dose radiotherapy
Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
DRUGHydroxychloroquine Sulfate
200 mg/12h for 5 days
DRUGRitonavir/lopinavir
400/100 mg/12h for 7-10 days
DRUGTocilizumab Injection [Actemra]
600 mg/day for 1-2 doses
DRUGAzithromycin
500 mg/24h for 3 days
DRUGCorticosteroid
Corticosteroids (methylprednisolone/dexamethasone/prednisone)
DRUGLow molecular weight heparin
low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
DEVICEOxygen supply
Oxygen
Sponsors
Hospital Universitario Madrid Sanchinarro
Hospital del Mar
Hospital Universitari Sant Joan de Reus
Grupo de Investigación Clínica en Oncología Radioterapia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years old * Moderate to severe COVID-19 pneumonia with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses * PAFIO2 of less than 300 mmHg or SaFI02 \<315 mmHg * Patients who are not candidates for admission to the Intensive Care Unit due to age, concomitant diseases or general condition. * One of the following conditions: * or IL6 greater than 40 * or PCR\> 100mg / l * D-dimer greater than 1500ng / ml * Suspected cytokine release syndrome * Have read the information sheet and signed the informed consent
Exclusion criteria
* Age \<18 years * Failure to meet the inclusion criteria * Leukopenia \<1000 * Pregnancy * Not understanding or refusing the purpose of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20% | Day 2 after interventional radiotherapy | To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. . In cases of impossibility the SaFiO2 will be determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the radiological image | Days 7 and day 30 after interventional radiotherapy | Chest CT |
| Overall mortality | Day 15 and Day 30 after interventional radiotherapy | Death of any cause |
| Measure of pro-inflammatory interleukins | Days 1, day 4 and day 7 after interventional radiotherapy | Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml) |
| Measure of trasforming growth factor (TGF-b) | Days 1, day 4 and day 7 after interventional radiotherapy | TGF-β (ng/ml) |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Day 30 and day 90 after interventional radiotherapy | Lung toxicity measured according to CTCAEv5 |
| Determining overexpression of pro-inflammatory selectin | Days 1, day 4 and day 7 after interventional radiotherapy | Overexpression of L-, E-, and P-selectin |
| Determining cell adhesion molecules (CAMs) | Days 1, day 4 and day 7 after interventional radiotherapy | Overexpression of ICAM-1, VCAM |
| Measure of marker of oxidative stress PON-1 | Days 1, day 4 and day 7 after interventional radiotherapy | PON-1(paraoxonase and arylesterase activity) (IU/ml) |
| Measure of tumor necrosis factor alpha (TNF-a) | Days 1, day 4 and day 7 after interventional radiotherapy | TNF-α (pg/ml) |
Countries
Spain
Contacts
Primary ContactANGEL MONTERO, Md, PhD
Outcome results
None listed