Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia

NCT04444531 | Completed

• 1 other identifier: COVID Networking group
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Time to clinical improvement

  Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate \<24 per minute, oxygen saturation \>94% on room air, and absence of cough) for at least 72 hours.

  28 days

Secondary Outcomes (6)

• Rate of patients with Clinical improvement at day 14

  14 days

• Rate of patients with Clinical improvement at day 28

  28 days

• Time to a 2-fold decrease of C-protein reactive from baseline

  28 days

• Time to a 2-fold decrease of ferritin from baseline

  28 days

• Time to a 2-fold decrease of Lactate Dehydrogenase from baseline

  28 days

Study Arms (2)

Ozone autohemotherapy plus standard treatment

Standard treatment alone

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Adults \>18yo hospitalised patients confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission), with severe pneumonia with baseline chest X-ray abnormalities + oxygen saturation \<94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.

You may qualify if:

• confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
• severe pneumonia with baseline chest X-ray abnormalities;
• Oxygen saturation \<94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
• Informed consent signed.

You may not qualify if:

• Not willing to participate in the study.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Policlinic Ibiza Hospital

Ibiza Town, Spain

Location

Related Publications (1)

• Hernandez A, Vinals M, Pablos A, Vilas F, Papadakos PJ, Wijeysundera DN, Bergese SD, Vives M. Ozone therapy for patients with COVID-19 pneumonia: Preliminary report of a prospective case-control study. Int Immunopharmacol. 2021 Jan;90:107261. doi: 10.1016/j.intimp.2020.107261. Epub 2020 Dec 5.

  PMID: 33310665 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Lead, MD, PhD, EDAIC

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 23, 2020
• Study Start: March 20, 2020
• Primary Completion: May 19, 2020
• Study Completion: May 26, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)