Blood Ozonization in Patients With SARS-CoV-2 Respiratory Failure

NCT04388514 | Unknown DMC

• 1 other identifier: CIG: Z7C2CA5837
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2 Respiratory Failure

Keywords

SARS-CoV-2; Respiratory Failure; COVID-19; medical ozone; ozone therapy; cytokine release syndrome

Outcome Measures

Primary Outcomes (2)

• Time of respiratory improvement and earlier weaning from oxygen support

  Evaluation of ABG paramethers the day after the last blood ozonization procedure (Day 3)

  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)

  10 days

Secondary Outcomes (4)

• Assessment of the length of hospitalization

  up to 90 days

• Assessment of the length of Intensive Care Unit (ICU) stay

  up to 90 days

• Improvment in chest imaging finding

  10 days

• Improvment in cytokine release syndrome

  10 days

Study Arms (2)

Blood ozonization

EXPERIMENTAL

Blood ozonization plus BAT

Procedure: Medical Ozone procedure

Standard of Care

NO INTERVENTION

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.

Interventions

Medical Ozone procedure 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.

Blood ozonization

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead
• Fondazione Toscana Gabriele Monasterio: collaborator
• Policlinico Militare, Roma - Italy: collaborator
• Ospedale San Liberatore di Atri: collaborator
• Ospedale Umberto I di Torino: collaborator
• Università di Siena: collaborator
• Ospedale Civile di Lucca: collaborator
• Ospedale di Siracusa: collaborator
• Azienda Sanitaria Locale di Vercelli: collaborator

Study Sites (1)

Dott. Amato De Monte

Udine, Italy

RECRUITING

Related Publications (5)

• Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.

  PMID: 32187464 BACKGROUND

• Elvis AM, Ekta JS. Ozone therapy: A clinical review. J Nat Sci Biol Med. 2011 Jan;2(1):66-70. doi: 10.4103/0976-9668.82319.

  PMID: 22470237 BACKGROUND

• Bocci VA. Scientific and medical aspects of ozone therapy. State of the art. Arch Med Res. 2006 May;37(4):425-35. doi: 10.1016/j.arcmed.2005.08.006.

  PMID: 16624639 BACKGROUND

• Smith NL, Wilson AL, Gandhi J, Vatsia S, Khan SA. Ozone therapy: an overview of pharmacodynamics, current research, and clinical utility. Med Gas Res. 2017 Oct 17;7(3):212-219. doi: 10.4103/2045-9912.215752. eCollection 2017 Jul-Sep.

  PMID: 29152215 BACKGROUND

• Gulmen S, Kurtoglu T, Meteoglu I, Kaya S, Okutan H. Ozone therapy as an adjunct to vancomycin enhances bacterial elimination in methicillin resistant Staphylococcus aureus mediastinitis. J Surg Res. 2013 Nov;185(1):64-9. doi: 10.1016/j.jss.2013.05.085. Epub 2013 Jun 19.

  PMID: 23809152 BACKGROUND

Related Links

• SIMEU Classification and Guidelines
• doi: 10.4081/ozone.2020.9014.

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Amato De Monte

  Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Udine - Italy

  STUDY CHAIR

Central Study Contacts

Carlo Tascini, MD

CONTACT

+39 0432 559355; c.tascini@gmail.com

Emanuela Sozio, MD

CONTACT

+39; emanuela.sozio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization, 1:1 ratio
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Diseases Department

Model Details: The study includes 2 arms: * Arm A: Blood ozonization plus BAT (n= 45 subjects) * Arm B: Standard of Care only without Blood ozonization (n= 45 subjects) 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

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: April 8, 2020
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Contacting the Principal Investigator

Locations

IT (1)