Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure (CORMOR)
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|ClinicalTrials.gov Identifier: NCT04388514|
Recruitment Status : Unknown
Verified May 2020 by Carlo Tascini, Azienda Sanitaria-Universitaria Integrata di Udine.
Recruitment status was: Recruiting
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Respiratory Failure||Procedure: Medical Ozone procedure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study includes 2 arms:
To note that the Standard of Care 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
|Masking Description:||Randomization, 1:1 ratio|
|Official Title:||Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure|
|Actual Study Start Date :||April 8, 2020|
|Estimated Primary Completion Date :||October 8, 2020|
|Estimated Study Completion Date :||October 8, 2020|
Experimental: Blood ozonization
Blood ozonization plus BAT
Procedure: Medical Ozone procedure
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.
No Intervention: Standard of Care
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.
- Time of respiratory improvement and earlier weaning from oxygen support [ Time Frame: 3 days ]Evaluation of ABG paramethers the day after the last blood ozonization procedure (Day 3)
- The time of respiratory improvement and earlier weaning from oxygen support [ Time Frame: 10 days ]Evaluation of ABG paramethers the one week after the last blood ozonization procedure (Day 10)
- Assessment of the length of hospitalization [ Time Frame: up to 90 days ]Asse the lenghth of hospital stay in the two arms
- Assessment of the length of Intensive Care Unit (ICU) stay [ Time Frame: up to 90 days ]Asse the lenghth of ICU stay in the two arms
- Improvment in chest imaging finding [ Time Frame: 10 days ]improving, worsening or stability of the chest imaging (chest CT, Chest XR and/or Point-of-Care Ultrasound) finding in the two arms
- Improvment in cytokine release syndrome [ Time Frame: 10 days ]Evaluation of plasmatic cytochine (IL-6, lymphocyte typing for CD4, CD3, CD8, HLA-DR, CD45) response in the two arms
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 were pregnancy, G6PHD (glucose 6 phosphate dehydrogenase) deficiency, concomitant serious disease and failure to obtain informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388514
|Contact: Carlo Tascini, MD||+39 0432 firstname.lastname@example.org|
|Contact: Emanuela Sozio, MDemail@example.com|
|Dott. Amato De Monte||Recruiting|
|Contact: Amato De Monte, MD|
|Study Chair:||Amato De Monte||Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Udine - Italy|
Documents provided by Carlo Tascini, Azienda Sanitaria-Universitaria Integrata di Udine:
|Responsible Party:||Carlo Tascini, Infectious Diseases Department, Azienda Sanitaria-Universitaria Integrata di Udine|
|Other Study ID Numbers:||
|First Posted:||May 14, 2020 Key Record Dates|
|Last Update Posted:||May 14, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||all IPD that underlie results in a publication|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||starting 6 months after publication|
|Access Criteria:||Contacting the Principal Investigator|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
cytokine release syndrome
Respiratory Tract Diseases