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Completed

NCT Number: NCT04444531

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

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

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Key information

Conditions

COVID-19 Pneumonia

Study type

Observational

Primary location

Policlinic Ibiza Hospital

Ibiza Town, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Time to clinical improvement

    Time frame: 28 days

    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.

Secondary outcomes

  1. Rate of patients with Clinical improvement at day 14

    Time frame: 14 days

    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.

  2. Rate of patients with Clinical improvement at day 28

    Time frame: 28 days

    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.

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

    Time frame: 28 days

  4. Time to a 2-fold decrease of ferritin from baseline

    Time frame: 28 days

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

    Time frame: 28 days

  6. Time to a 2-fold decrease of D-dimer from baseline

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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