Clinical trial NCT04370223: Ozone Auto-hemotherapy for COVID-19 Pneumonia
Official title: A Trial of Ozone Auto-hemotherapy in Adults Hospitalized With Covid-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19 Pneumonia
Keywords: Ozone therapy
Covid-19
SARS-COV-2
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
Collaborators: name: Clinica Nuestra Senora del Rosario
First posted: 2020-04-30
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients achieving improvement in clinical condition at day 14 after recruitment
timeFrame: 14 days
Secondary outcomes:
measure: Mortality at day 28
timeFrame: 28 days
measure: Rate of patients achieving improvement in clinical condition at day 28 after recruitment
timeFrame: 28 days
measure: Rate of patients achieving improvement in clinical condition at day 7 after recruitment
timeFrame: 7 days
measure: Time to clinical improvement or hospital discharge
timeFrame: 28 days
measure: Number of ventilator-free days at 28 days
timeFrame: 28 days
measure: Hospital length of stay
timeFrame: 28 days
measure: Time to a 2-fold decrease in ferritin
timeFrame: 14 days
measure: Time to a 2-fold decrease in C-protein reactive
timeFrame: 14 days
measure: Time to a 2-fold decrease in Dimer-D
timeFrame: 14 days
measure: Time to a 2-fold decrease in Lactate Dehydrogenase
timeFrame: 14 days
measure: Time to a 2-fold decrease in Neutrophils to Lymphocytes ratio
timeFrame: 14 days
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr Josep Trueta
city: Ibiza
country: Spain
facility: Clinica Nuestra Señora del Rosario
city: Madrid
country: Spain
facility: Hospital Quirón Rey Juan Carlos I
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias de Alcalá de Henares
city: Manresa
country: Spain
facility: Fundació Althaia de Manresa
city: Valencia
country: Spain
facility: Hospital Vithas Valencia Consuelo
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Clinica Claro
Study officials:
References: