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ClinicalTrials.gov; 22/04/2020; TrialID: NCT04366089
Clinical Trial Register | ICTRP | ID: ictrp-NCT04366089

ABSTRACT

Condition:

COVID;SARS-CoV 2;Pneumonia, Viral;Coronavirus Infection

Intervention:

Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care;Dietary Supplement: SivoMixx (200 billion);Drug: Azithromycin;Drug: hydroxychloroquine

Primary outcome:

Delta in the number of patients requiring orotracheal intubation despite treatment

Criteria:


Inclusion Criteria:

- Age > 18 years

- Nasopharyngeal swab positive for COVID-19

- COVID-19 stages I - II - III (*1)

- Hospitalization in the Department of Infectious Diseases

Exclusion Criteria:

- 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)"


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