Compassionate use of rectal Ozone (O3) in severe COVID-19 pneumonia: a case-control study.

Abstract

Objectives: To evaluate effect of rectal Ozone in severe COVID-19 pneumonia and to compare to Standard-of-care (SOC). Material and Methods: In a case-control study, 14 patients with severe bilateral COVID-19 pneumonia (positive RT-PCR), treated with SOC and rectal Ozone, were evaluated before-and-after treatment and compared with SOC (14 patients) in a 10 day follow-up period. Ozone-protocol consisted of 8 sessions (1 session/day) of intra-rectal Ozone, (150mL volume, 35mg/ml concentration [5.25mg total dose]). The SOC-protocol included O 2- supply, antivirals (Remdesivir), corticosteroids (Dexamethasone/Metilprednisolone), monoclonal antibodies (Anakinra/Tocilizumab), antibiotics (Azytromicine), anticoagulants (Enoxaparine) and hyperimmune serum (if necessary). Primary outcome variables: a) clinical (O 2- saturation and O 2- supply); b) biochemical (Lymphocyte count, Fibrinogen, D-Dimer, Urea, Ferritin, LDH, IL-6 and CRP); c) radiological Taylor Scale. Secondary outcome variables: a) hospitalization length-of-stay, b) mortality-rate. Results: At baseline, Ozone/SOC-groups were not different on age, comorbidities, O 2 -saturation and O 2 -supply. Patients in Ozone-Group improved O 2- saturation and decrease O 2- supply. SOC maintained O 2- saturation and required more O 2- supply. Lymphocyte-count improved only in Ozone-group and with statistical difference (p<0.05). Biomarkers of inflammation (Fibrinogen, D-Dimer, Urea, LDH, CRP and IL-6) decreased in both groups, but only significantly in favor of Ozone-group (p<0.05). Ferritin showed a significant decrease in the Ozone-group but an increase on the SOC-Group. Radiological pneumonitis decreased on both groups but the decrease was only significant in the Ozone-Group (p<0.0001). Mortality and length-of-stay, although not significant, were inferior in Ozone-Group. Conclusion: Compassionate use of Rectal Ozone improved O 2 -saturation, reduced O 2 -supply, decreased inflammation biomarkers and improved Taylor’s radiological scale significantly when compared to SOC-Group. Mortality and length-of-stay was inferior in the Ozone-group, but this difference was not significant.

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

“…Furthermore, other single centre experiences reported clinical, radiological and biochemical improvement using of Ozone with different administration techniques as rectal ozone or ozonized saline solution [10] , [37] , [38] , [39] .…”

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

“…To date, almost 1661 clinical trials are in course to determine the best treatment for COVID-19 infection, but most of the pharmacological therapies investigated have not demonstrated effectivity in the management of SARS-CoV-2 pandemic [4,16]. From the clinical trials evaluating ozone therapy, only 2 of them have published their results [7,13]. This study presents the use of a homogeneous rectal ozone protocol in two different cohorts of COVID-19 patients regarding location, ethnicity and age, and the effects from one population were reproducible in the other one.…”

“…Lately, our Research Group has presented the preliminary results of rectal ozone for the management of mild-severe COVID-19, with very promising results [13,14]. Although our patients treated were older (mean age 83 years), there is no report of a similar study considering the treatment of younger patients, using the same protocol.…”