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

COVID-19 Pneumonia Clinical Trial

Official title:

Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444531
• Other study ID #: COVID Networking group
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: May 26, 2020

Study information

• Verified date: November 2020
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 26, 2020
• Est. primary completion date: May 19, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not willing to participate in the study.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Locations

Country	Name	City	State
Spain	Policlinic Ibiza Hospital	Ibiza

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of patients with Clinical improvement at day 14	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.	14 days
Secondary	Rate of patients with Clinical improvement at day 28	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	Time to a 2-fold decrease of C-protein reactive from baseline		28 days
Secondary	Time to a 2-fold decrease of ferritin from baseline		28 days
Secondary	Time to a 2-fold decrease of Lactate Dehydrogenase from baseline		28 days
Secondary	Time to a 2-fold decrease of D-dimer from baseline		28 days