Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Hydroxychloroquine Sulfate
- Conditions
- Pneumonia, Viral
- Sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Enrollment
- 106
- Locations
- 3
- Primary Endpoint
- Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Control group
a control group only receive pharmacological treatment
Intervention: Hydroxychloroquine Sulfate
Control group
a control group only receive pharmacological treatment
Intervention: Ritonavir/lopinavir
Control group
a control group only receive pharmacological treatment
Intervention: Tocilizumab Injection [Actemra]
Control group
a control group only receive pharmacological treatment
Intervention: Azithromycin
Control group
a control group only receive pharmacological treatment
Intervention: Corticosteroid
Control group
a control group only receive pharmacological treatment
Intervention: Low molecular weight heparin
Control group
a control group only receive pharmacological treatment
Intervention: Oxygen supply
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Low-dose radiotherapy
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Hydroxychloroquine Sulfate
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Ritonavir/lopinavir
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Tocilizumab Injection [Actemra]
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Azithromycin
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Corticosteroid
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Low molecular weight heparin
Experimental group
an experimental group will receive low-dose lung irradiation
Intervention: Oxygen supply
Outcomes
Primary Outcomes
Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%
Time Frame: 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 Outcomes
- Change of the radiological image(Days 7 and day 30 after interventional radiotherapy)
- Overall mortality(Day 15 and Day 30 after interventional radiotherapy)
- Measure of trasforming growth factor (TGF-b)(Days 1, day 4 and day 7 after interventional radiotherapy)
- Determining overexpression of pro-inflammatory selectin(Days 1, day 4 and day 7 after interventional radiotherapy)
- Measure of marker of oxidative stress PON-1(Days 1, day 4 and day 7 after interventional radiotherapy)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Day 30 and day 90 after interventional radiotherapy)
- Measure of pro-inflammatory interleukins(Days 1, day 4 and day 7 after interventional radiotherapy)
- Measure of tumor necrosis factor alpha (TNF-a)(Days 1, day 4 and day 7 after interventional radiotherapy)
- Determining cell adhesion molecules (CAMs)(Days 1, day 4 and day 7 after interventional radiotherapy)