Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Multicentric Study on the Effect of Rectal Ozone on COVID-19: the Spanish and Slovakian Experience.

Version 1 : Received: 13 March 2022 / Approved: 19 March 2022 / Online: 19 March 2022 (03:35:45 CET)

How to cite: Fernandez-Cuadros, M.; Albaladejo-Florin, M.J.; Pérez-Moro, O.; Rodríguez-de-Cía, J.; Hernández, A.; Alava-Rabasa, S.; Mohammed, D.; Gondzurova, A.; Molnar, M.; Kulinova, M.; Vyletelka, J. Multicentric Study on the Effect of Rectal Ozone on COVID-19: the Spanish and Slovakian Experience.. Preprints 2022, 2022030272 (doi: 10.20944/preprints202203.0272.v1). Fernandez-Cuadros, M.; Albaladejo-Florin, M.J.; Pérez-Moro, O.; Rodríguez-de-Cía, J.; Hernández, A.; Alava-Rabasa, S.; Mohammed, D.; Gondzurova, A.; Molnar, M.; Kulinova, M.; Vyletelka, J. Multicentric Study on the Effect of Rectal Ozone on COVID-19: the Spanish and Slovakian Experience.. Preprints 2022, 2022030272 (doi: 10.20944/preprints202203.0272.v1).

Abstract

Objective: To evaluate the effect of rectal Ozone (O3) in severe COVID-19 pneumonia in two different cohorts differing in location (Madrid vs Zilina), ethnicity (Slovakian vs Spanish cohorts) and age. Material and Methods: In a multicenter-study, 32 severe bilateral-COVID-19-pneumonia patients and (+) RT-PCR (reverse transcriptase polymerase chain reaction) SARS-CoV-2 were evaluated (16 from each cohort). Primary outcomes: a) clinical (O2-saturation); b) biochemical (Lymphocyte-count, Fibrinogen, D-Dimer, Urea, Ferritin, LDH [lactate dehydrigenase], IL-6 and CRP [c-reactive protein]); and c) radiological improvement. Secondary outcomes: a) days-of-hospitalization, b) mortality-rate before discharge. The Ozone-protocol consisted of 10 sessions of intra-rectal Ozone, total dose 5.25 mg (150 mL volume, 35 g/ml concentration). The Standard-of-care protocol included O2 supply, antivirals (Remdesivir / Isoprinosine), corticosteroids (Dexamethasone / Metilprednisolone), monoclonal antibodies (Anakinra / Tocilizumab), antibiotics (Azytromicine), anticoagulants (Enoxaparine / Fraxiparine). Protocol was approved by Health Care Ethics Committee (Report 15/4/2020) of our Hospital and by Ethics Committee for Medical Investigation of La Princesa’s Hospital (ACTA CEIm 12/20, 28/5/20, Registry 4146). Results: Patients in Slovakian cohort were younger (53.38 vs 84.69 years). Grade of severity was worse in Spanish-cohort (4.78 vs 3.30 points). Length of stay was superior in Spanish-cohort (27.38 vs 10.07 days). Both cohorts improved O2-saturation and Lymphocyte-count. Inflammation biomarkers (Fibrinogen, D-Dimer, Urea, Ferritin, LDH, CRP and IL-6) decreased in both cohorts. In Spanish-cohort, Urea and Ferritin improvement was not significant (p>0.05), while in Slovakian-cohort, Urea, Fibrinogen and LDH were not significant (p>0.05) Radiological signs of bilateral pneumonitis decreased on both cohorts. Mortality was similar (12.5%). Conclusion: After Standard of care protocol, Rectal Ozone improved O2-saturation, decreased inflammation biomarkers and improved Taylor’s radiological scale in both cohorts. Although age, grade of severity and days of hospitalization were inferior in Slovakian cohort, mortality was similar in both cohorts, but inferior if compared to an external control cohort.

Keywords

Ozone; Ozone therapy; pneumonia; COVID-19; SARS-CoV-2; rectal insufflation

Subject

MEDICINE & PHARMACOLOGY, General Medical Research

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