CORonavirus-19 mild to moderate pneumonia Management with blood Ozonization in patients with Respiratory failure (CORMOR) multicentric prospective randomized clinical trial

Int Immunopharmacol. 2021 Sep;98:107874. doi: 10.1016/j.intimp.2021.107874. Epub 2021 Jun 12.

Abstract

Background: Following positive experience on the use of blood ozonation in SARS-CoV-2, the CORMOR randomized trial was designed to evaluate the adjuvant role of oxygen/ozone therapy in mild to moderate SARS-CoV-2 pneumonia.

Methods: The trial (ClinicalTrial.gov NCT04388514) was conducted in four different Italian centers (April-October 2020). Patients were treated according to best available standard of care (SoC) therapy, with or without O3-autohemotherapy (O3-AHT).

Results: A total of 92 patients were enrolled: SoC + O3-AHT (48 patients) were compared to the SoC treatment (44 patients). The two groups differed in steroids therapy administration (72.7% in SoC arm vs. 50.0% in O3-AHT arm; p = 0.044). Steroid therapy was routinely started when it was subsequently deemed as effective for the treatment of COVID-19 disease. No significant differences in mortality rates, length of hospital stay, mechanical ventilation requirement and ICU admission were observed. Clinical improvement in patients with pneumonia was assessed according to a specifically designed score (decrease in SIMEU class, improvement in radiology imaging, improvement in PaO2/FiO2, reduction in LDH and requirement of oxygen therapy ≤ 5 days). Score assessment was performed on day-3 (T3) and day-7 (TEnd) of O3-AHT treatment. A significant increase in the score was reported at TEnd, in the O3-AHT treatment arm (0 [0-1] in the SoC arm vs. 2 [1-3] the O3-AHT arm; p = 0.018). No adverse events related O3-AHT treatment was observed.

Conclusion: In mild-to-moderate pneumonia due to SARS-CoV-2, adjuvant oxygen/ozone therapy did not show any effect on mortality, or mechanical intubation but show a clinical improvement a day 7 from randomization in a composite clinical endpoint. Larger Randomized prospective studies alone or in combination with steroids are needed to confirm our results.

Keywords: Autotransfusion; COVID-19; Cytokine release syndrome; Medical ozone; Ozone gas; Ozone therapy; SARS-CoV-2.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • COVID-19 / blood
  • COVID-19 / mortality
  • COVID-19 / physiopathology
  • COVID-19 / therapy*
  • Female
  • Hospital Mortality
  • Humans
  • Italy
  • Length of Stay
  • Lung / physiopathology*
  • Lung / virology
  • Male
  • Middle Aged
  • Ozone / administration & dosage*
  • Ozone / adverse effects
  • Ozone / blood
  • Prospective Studies
  • Respiration, Artificial
  • Respiratory Insufficiency / blood
  • Respiratory Insufficiency / mortality
  • Respiratory Insufficiency / physiopathology
  • Respiratory Insufficiency / therapy*
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Substances

  • Ozone