Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19
- Conditions
- Pneumonia, Viral
- Interventions
- Radiation: Low-dose radiotherapyDrug: Ritonavir/lopinavirDrug: CorticosteroidDrug: Low molecular weight heparinDevice: Oxygen supply
- Registration Number
- NCT04380818
- Lead Sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 106
-
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
- Age <18 years
- Failure to meet the inclusion criteria
- Leukopenia <1000
- Pregnancy
- Not understanding or refusing the purpose of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Tocilizumab Injection [Actemra] a control group only receive pharmacological treatment Experimental group Tocilizumab Injection [Actemra] an experimental group will receive low-dose lung irradiation Control group Low molecular weight heparin a control group only receive pharmacological treatment Experimental group Low-dose radiotherapy an experimental group will receive low-dose lung irradiation Experimental group Oxygen supply an experimental group will receive low-dose lung irradiation Control group Ritonavir/lopinavir a control group only receive pharmacological treatment Control group Corticosteroid a control group only receive pharmacological treatment Control group Oxygen supply a control group only receive pharmacological treatment Experimental group Ritonavir/lopinavir an experimental group will receive low-dose lung irradiation Experimental group Corticosteroid an experimental group will receive low-dose lung irradiation Experimental group Low molecular weight heparin an experimental group will receive low-dose lung irradiation Control group Hydroxychloroquine Sulfate a control group only receive pharmacological treatment Control group Azithromycin a control group only receive pharmacological treatment Experimental group Hydroxychloroquine Sulfate an experimental group will receive low-dose lung irradiation Experimental group Azithromycin an experimental group will receive low-dose lung irradiation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change of the radiological image Days 7 and day 30 after interventional radiotherapy Chest CT
Determining overexpression of pro-inflammatory selectin Days 1, day 4 and day 7 after interventional radiotherapy Overexpression of L-, E-, and P-selectin
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)
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
Overall mortality Day 15 and Day 30 after interventional radiotherapy Death of any cause
Measure of trasforming growth factor (TGF-b) Days 1, day 4 and day 7 after interventional radiotherapy TGF-β (ng/ml)
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 tumor necrosis factor alpha (TNF-a) Days 1, day 4 and day 7 after interventional radiotherapy TNF-α (pg/ml)
Determining cell adhesion molecules (CAMs) Days 1, day 4 and day 7 after interventional radiotherapy Overexpression of ICAM-1, VCAM
Trial Locations
- Locations (3)
Hospital Sant Joan de Reus
🇪🇸Reus, Tarragona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Madrid Sanchinarro
🇪🇸Madrid, Spain