SARS-CoV-2 Respiratory Failure Clinical Trial
Official title:
Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure
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.
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