Covid-19 pneumonia
Conditions
Interventions
Product Name: Ozone
Product Code: SUB33402
Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion
INN or Proposed INN: ozone
CAS Number: 10028-15-6
Other descriptive name: OZONE
Co
Sponsors
Políclinica Nuestra Señora del Rosario
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women over 18 years of age. 2. Diagnosis of COVID-19 confirmed by positive nasopharyngeal PCR. 3. Lung infiltrate confirmed by imaging test (chest X-ray or CT) + patient with severe pneumonia (failure of > = 1 organ or SpO2 ambient air of = 30) with need for oxygen with nasal canula , Venturi mask, non-rebreathing mask, high-flow nasal goggles or non-invasive mechanical ventilation (NIMV). 4. Evolution time of =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Patients who have received treatment with systemic ozone six months before admission to the hospital. 2. Patients who have previously experienced some type of adverse reaction to ozone therapy. 3. Patients who are aware of having a glucose-6-phosphate-dehydrogenase deficiency 4. Patients who are not able to clearly understand the objectives and methodology of the study. 5. Pregnant or lactating patients. 6. Patients who are intubated with invasive mechanical ventilation. 7. Patients with decompensated concomitant pathology and / or associated infectious pathology not related to COVID-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 28;Secondary Objective: To determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 14 To determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 7 To determine whether the use of ozonated blood cause a decrease in time to clinical improvement To determine whether the use of ozonated blood cause a decrease in days to obtained a 2-fold decrease in inflammatory markers levels from baseline To determine whether the use of ozonated blood cause a decrease in days to improvement of oxygenation index To determine whether the use of ozonated blood cause a decrease in days in hospital stay To determine whether the use of ozonated blood cause a decrease in in-hospital or 28 days mortality;Primary end point(s): Rate of patients achieving clinical improvement at day 28;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -time (days) to clinical improvement or discharge from hospital - mortality 28 days after randomization in-hospital mortality. -% of patients who have achieved clinical improvement on days 7 and 14 - number of days alive and free from mechanical ventilation at 28 days -% of patients requiring intubation - time (days) until a decrease of more than 50% of the levels of ferritin, D-dimer, CRP and LDH, neutrophil-lymphocyte ratio from baseline - time (days) until improvement of the oxygenation index with PaO2 / FiO2> 300 mmHg, or SpO2 / FiO2 > 315 - number of days of ICU stay, hospital stay;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Spain
Contacts
Public ContactMarc Vives
Hospital Universitario de Girona
Outcome results
None listed