Blood Ozonization in Patients With 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.

Conditions

• SARS-CoV-2 Respiratory Failure

Interventions

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.

Sponsors & Collaborators

• Fondazione Toscana Gabriele Monasterio

  collaborator OTHER

• Policlinico Militare, Roma - Italy

  collaborator UNKNOWN

• Ospedale San Liberatore di Atri

  collaborator UNKNOWN

• Ospedale Umberto I di Torino

  collaborator OTHER

• Università di Siena

  collaborator UNKNOWN

• Ospedale Civile di Lucca

  collaborator UNKNOWN

• Ospedale di Siracusa

  collaborator UNKNOWN

• Azienda Sanitaria Locale di Vercelli

  collaborator OTHER

• Azienda Sanitaria-Universitaria Integrata di Udine

  lead OTHER

Principal Investigators

• Amato De Monte · Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Udine - Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-08

Primary Completion

2020-10-08

Completion

2020-10-08

Countries

• Italy

Study Locations