An interventional study of Medical Ozone procedure in SARS-CoV-2 Respiratory Failure, sponsored by Azienda Sanitaria-Universitaria Integrata di Udine. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by Azienda Sanitaria-Universitaria Integrata di Udine · Not applicable, Interventional, and Treatment
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:
1,650 studies on the registry are indexed under Respiratory Insufficiency; 297 are open to participants now.
This study's planned enrollment of 90 is above the median of 55 across 1,042 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Azienda Sanitaria-Universitaria Integrata di Udine is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blood ozonization plus BAT
Procedure: Medical Ozone procedure
BAT "only" To note that the BAT are therapy with antiretroviral therapy (lopinavir/ritonavir 2 tablets every 12 hours or darunavir/cobicistat 1 tablet per day) and hidrossycloroquine 400 mg every 12 hours then first day, followed by 200 mg every 12 hours for other 4 days.
The systemic ozone treatment procedure was decided by the physician on duty and started preliminarily at the patient's bed with the drawing of autologous blood and, after proper O2/O3 mixing, with its re-infusion. After junction of an adequate venous patient's way with a dedicated latex free plastic bag containing 35 ml of sodium citrate, a blood amount of 200 ml is taken. At the end, the withdrawal line was washed and the re-infusion one was filled with saline solution. The blood, without any patient disconnection, was then mixed with a gas mixture of a 200 cc composed by 96% of Oxygen and 4% of Ozone with a therapeutic O3 range of 40 μg/mL of gas per mL of blood. In order to guarantee the O2/O3 homogeneous diffusion into the blood, the bag was gently mixed for about 10 minutes, therefore the blood was re-infused into the patients. The duration of ozone treatment lasted for 3 consecutive days.
Time of respiratory improvement and earlier weaning from oxygen support
Evaluation of ABG paramethers the day after the last blood ozonization procedure (Day 3)
Time frame: 3 days
The time of respiratory improvement and earlier weaning from oxygen support
Evaluation of ABG paramethers the one week after the last blood ozonization procedure (Day 10)
Time frame: 10 days
Assessment of the length of hospitalization
Asse the lenghth of hospital stay in the two arms
Time frame: up to 90 days
Assessment of the length of Intensive Care Unit (ICU) stay
Asse the lenghth of ICU stay in the two arms
Time frame: up to 90 days
Improvment in chest imaging finding
improving, worsening or stability of the chest imaging (chest CT, Chest XR and/or Point-of-Care Ultrasound) finding in the two arms
Time frame: 10 days
Improvment in cytokine release syndrome
Evaluation of plasmatic cytochine (IL-6, lymphocyte typing for CD4, CD3, CD8, HLA-DR, CD45) response in the two arms
Time frame: 10 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Csr
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Azienda Sanitaria-Universitaria Integrata di Udine