NCT04444531 - Ozone Therapy and Coronavirus Disease of 2019 (COVID-19) Pneumonia | Crick

Overview

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

Study Type

OBSERVATIONAL

Enrollment

18

Conditions

COVID-19 Pneumonia

Eligibility

Medical Language ↔ Plain English

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.

Locations (1)

Policlinic Ibiza Hospital

Ibiza Town, Spain

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Secondary Outcomes

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.

Time frame: 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.