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Int Immunopharmacol
. 2021 Jun 12;98:107874.
doi: 10.1016/j.intimp.2021.107874. Online ahead of print.
CORonavirus-19 mild to moderate pneumonia Management with blood Ozonization in patients with Respiratory failure (CORMOR) multicentric prospective randomized clinical trial
Emanuela Sozio 1, Amato De Monte 2, Giovanni Sermann 3, Flavio Bassi 4, Davide Sacchet 5, Francesco Sbrana 6, Andrea Ripoli 7, Francesco Curcio 8, Martina Fabris 9, Stefania Marengo 10, Daniele Italiani 11, Daniela Luciana Boccalatte-Rosa 12, Carlo Tascini 13, CORMOR study Group
Affiliations expand
- PMID: 34186281
- PMCID: PMC8196321
- DOI: 10.1016/j.intimp.2021.107874
Free PMC article
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.