Status:
UNKNOWN
Ozone Auto-hemotherapy for COVID-19 Pneumonia
Lead Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborating Sponsors:
Clinica Nuestra Senora del Rosario
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2020
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04370223
Start Date
May 25 2020
End Date
December 25 2020
Last Update
June 9 2020
Active Locations (10)
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1
Hospital Universitari Dr Josep Trueta
Girona, Spain, 17007
2
Clinica Nuestra Señora del Rosario
Ibiza Town, Spain
3
Hospital Quirón Rey Juan Carlos I
Madrid, Spain
4
Hospital Universitario 12 de Octubre
Madrid, Spain