COVID-19 Pneumonia
Conditions
Keywords
Ozone therapy, Covid-19, SARS-COV-2
Brief summary
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
Interventions
BIOLOGICALOzone auto-hemotherapy
ozone auto-hemotherapy
Sponsors
Clinica Nuestra Senora del Rosario
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COVID-19 confirmed by positive polymerase chain reaction (PCR) for Severe Acute Respiratory Syndrome (SARS-COV-2) in respiratory tract sample, plus pneumonia confirmed by imaging tests and arterial oxygen saturation (SpO2) \<94% with ambient air or a partial pressure of oxygen to fraction of inspired oxygen (pO2/FiO2) ratio \<300 mmHg or SpO2/FiO2 ≤ 315. * Acceptance to participate in the study and signing of the informed consent.
Exclusion criteria
* Patients who have received treatment with any form of ozone therapy 6 months before admission to the hospital. * Patients who have previously been treated and have experienced some type of adverse reaction to ozone therapy. * Patients aware of having a deficiency of Glucose-6-phosphate dehydrogenase. * Patients with clinically decompensated chronic comorbidities, independently of COVID-19. * Patients suffering from any psychiatric disorder specified in axis I of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), other than major depression. * Patients who are not able to clearly understand the objectives and methodology of the study. * Pregnant or lactating patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients achieving improvement in clinical condition at day 14 after recruitment | 14 days | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients achieving improvement in clinical condition at day 28 after recruitment | 28 days | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) |
| Rate of patients achieving improvement in clinical condition at day 7 after recruitment | 7 days | 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 to clinical improvement or hospital discharge | 28 days | Improved clinical condition defined by an improvement of 2 points in the clinical status, 8 categories, ordinary score of the World Health Organization (WHO) |
| Number of ventilator-free days at 28 days | 28 days | Ventilator-free days from last extubation day until day 28 after recruitment |
| Hospital length of stay | 28 days | Days hospitalized |
| Mortality at day 28 | 28 days | mortality |
| Time to a 2-fold decrease in C-protein reactive | 14 days | Number of days until a 2-fold decrease in C-Protein Reactive (mg/L) |
| Time to a 2-fold decrease in Dimer-D | 14 days | Number of days until a 2-fold decrease in Dimer-D (ng/mL) |
| Time to a 2-fold decrease in Lactate Dehydrogenase | 14 days | Number of days until a 2-fold decrease in Lactate Dehydrogenase (U/L) |
| Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio | 14 days | Number of days until a 2-fold decrease in Neutrophils to Lymphocytes ratio |
| Time to a 2-fold decrease in ferritin | 14 days | Number of days until a 2-fold decrease in ferritin (ng/mL) |
Countries
Spain
Contacts
Primary ContactAlberto Hernández, MD, PhD
Backup ContactMarc Vives, MD, PhD
Outcome results
None listed