Status:
UNKNOWN
Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora
Lead Sponsor:
Roberto Poscia MD, PhD
Conditions:
COVID
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidi...
Detailed Description
Several studies analyzed the mechanisms by which ozone therapy could combat viral infections. In particular, 1) the improvement of the release of oxygen in the peripheral tissues, 2) the anti-inflamma...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Nasopharyngeal swab positive for COVID-19
- COVID-19 stages I - II - III (\*1)
- Hospitalization in the Department of Infectious Diseases
Exclusion
- COVID-19 stages IV - V - VI (\*1)
- Hospitalization in Intensive Care Units
- Pregnancy
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Patients who deny consent to the proposed treatment
- Inability to provide informed consent
- Contraindications to performing oxygen-ozone therapy
- hyperhomocysteinemia
- favism or thyroiditis
- coagulopathies
- neurodegenerative diseases
- angina (in particular Prinzmetal's angina) or with previous myocardial infarction
- (\*1) Compliant with indications published by:
- Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI).
- Care pathway for the patient with COVID-19.
- Section 2 - Recommendations for local management of the critically ill patient - Version 2
- Available on http://www.siaarti.it/SiteAssets/News/COVID19%20-%20documenti%20SIAARTI/Percorso%20COVID-19%20-%20Sezione%202%20-%20Raccomandazioni%20per%20la%20gestione%20locale%20-%20Rev%202.0.pdf
- Last accessed 20/04/2020
- Posted on 26.03.2020
- On page 2 of the previous document :
- "6 identified stages:
- sick disease - mild COVID-19 (I stage)
- light pneumonia - mild COVID-19 (II stage)
- serious pneumonia - severe COVID-19 (III stage)
- Acute respiratory distress syndrome (ARDS) - critical COVID-19 (IV stage)
- sepsis - critical COVID-19 (V stage)
- septic shock - critical COVID-19 (VI stage)"
Key Trial Info
Start Date :
March 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04366089
Start Date
March 26 2020
End Date
December 31 2020
Last Update
April 28 2020
Active Locations (1)
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1
Francesco Pugliese
Rome, RM, Italy, 00161