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Trial - NCT04366089


Column Value
Trial registration number NCT04366089
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04366089

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Francesco Pugliese, MD, PhD

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

f.pugliese@uniroma1.it

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-28

Recruitment status
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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)"

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Roberto Poscia MD, PhD

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Italy

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

152

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Delta in the number of patients requiring orotracheal intubation despite treatment

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2246, "treatment_name": "Oxygen-ozone+probiotics", "treatment_type": "Others non pharmacological treatment+microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]