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

Study Overview
=================
Brief Summary
-----------------
The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement

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

Conditions
-----------------
COVID-19 Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ozone autohemotherapy plus standard treatment<br> | |
| Standard treatment alone<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Time to a 2-fold decrease of D-dimer from baseline |  | 28 days |