blood ozonization in patients with sars-cov-2 respiratory failure

Conditions: SARS-CoV-2 Respiratory Failure

Summary: aim. the emerging outbreak of coronavirus disease 2019 (covid-19) caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) continues to spread worldwide. beside the prescription of some promising drugs as chloroquine, azithromycin, antivirals (lopinavir/ritonavir, darunavir/cobicistat) and immunomodulating agents (steroids, tocilizumab), in our patients with mild to moderate pneumonia due to sars-cov-2 we planned a randomize study to evaluate, respect the best available therapy (bat), the use of autohemotherapy treatement with an oxygen/ozone (o3) gaseous mixture as adjuvant therapy. design. multicentric, randomized study. participants. clinical presentations are based upon clinical phenotypes identified by the italian society of emergency and urgency medicine (simeu - società italiana di medicina di emergenza-urgenza) and patients that meet criteria of phenotypes 2 to 4 were treat with best available therapy (bat), and randomized to receive or not o3-autohemotherapy. main outcome measures. the end-point were the time of respiratory improvement and earlier weaning from oxygen support: these parameters were included in the simeu clinical phenotypes classification.

recruitment details. the investigator enrolled, in the study, subjects with covid-19 modest to moderate respiratory insufficiency (simeu clinical phenotypes 2-4) thus cared in an infectious disease ward. to note that the italian society of emergency and urgency medicine (simeu - società italiana di medicina di emergenza-urgenza) suggest to classified the covid-19 patients in 5 clinical phenotypes: * phenotype 1: subjects with fever and without respiratory failure (normal arterial blood gas analysis - abg -, six-minute walking test - 6mwt - and chest xr). these patients usually can manage at home maintaining quarantine period. * phenotype 2: subjects with fever but with abg and/or chest xr indicative of modest respiratory insufficiency (po2\> 60 mmhg in ambient air) and / or pulmonary consolidation area. these patients need to be hospitalized because they can get quickly worse. * phenotype 3: subjects with fever associate to moderate-severe respiratory insufficiency (at triage po2\< 60 mmhg in ambient air) and /or bilateral pulmonary consolidation area at chest xr. these patients need to be treated with high flow oxygen therapy. * phenotype 4: subjects with respiratory failure with suspected ards (adult respiratory distress syndrome) or complicated pneumonia. these patients require hospitalization in sub-intensive care unit. * phenotype 5: subject with ards at the beginning. these patients will require intensive care unit (icu) admission and non-invasive positive pressure ventilation (nippv) or mechanical ventilation.

Eligibility criteria:
inclusion criteria: * male and no pregnant female patients 18 years of age or older were eligible if they had a diagnostic specimen that was positive on rt-pcr, had pneumonia confirmed by chest imaging and gave their informed consent to participate at the study exclusion criteria: * exclusion criteria were pregnancy, g6phd (glucose 6 phosphate dehydrogenase) deficiency, concomitant serious disease and failure to obtain informed consent.

Keywords: sars-cov-2 respiratory failure covid-19 medical ozone ozone therapy cytokine release syndrome