This is a multicenter, randomized, controlled, open-label clinical trial testing the use of ozone auto-hemotherapy in hospitalized patients with Covid-19 pneumonia. Eligible patients will be randomly assigned to receive either ozone auto-hemotherapy plus standard treatment, or standard treatment alone. Patients in the ozone auto-hemotherapy group will receive treatment mixing 100-200ml of blood with ozone at a concentration of 40 μg / mL with a gas volume of 200 ml. Treatment will occur every 12h during 5 days. Standard treatment will be the one used in each hospital participating in the trial. All analyses will be done according to the intention-to-treat principle
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
ozone auto-hemotherapy
Hospital Universitari Dr Josep Trueta
Girona, Spain
Clinica Nuestra Señora del Rosario
Ibiza Town, Spain
Hospital Quirón Rey Juan Carlos I
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Príncipe de Asturias de Alcalá de Henares
Madrid, Spain
Fundació Althaia de Manresa
Manresa, Spain
Hospital Vithas Valencia Consuelo
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Clinica Claro
Vigo, Spain
Rate of patients achieving improvement in clinical condition at day 14 after recruitment
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Time frame: 14 days
Mortality at day 28
mortality
Time frame: 28 days
Rate of patients achieving improvement in clinical condition at day 28 after recruitment
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Time frame: 28 days
Rate of patients achieving improvement in clinical condition at day 7 after recruitment
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Time frame: 7 days
Time to clinical improvement or hospital discharge
Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO)
Time frame: 28 days
Number of ventilator-free days at 28 days
Ventilator-free days from last extubation day until day 28 after recruitment
Time frame: 28 days
Hospital length of stay
Days hospitalized
Time frame: 28 days
Time to a 2-fold decrease in ferritin
Number of days until a 2-fold decrease in ferritin (ng/mL)
Time frame: 14 days
Time to a 2-fold decrease in C-protein reactive
Number of days until a 2-fold decrease in C-Protein Reactive (mg/L)
Time frame: 14 days
Time to a 2-fold decrease in Dimer-D
Number of days until a 2-fold decrease in Dimer-D (ng/mL)
Time frame: 14 days
Time to a 2-fold decrease in Lactate Dehydrogenase
Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L)
Time frame: 14 days
Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio
Time frame: 14 days
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