Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection

Effect of Inhalation Administration of Ozone Plasma on Lung Function and Inflammatory Parameters in Patients With Pulmonary Sequelae Associated With Coronavirus 19 Infection (SARS-COV-2)

The risk for the development of complications from COVID-19 occurs mainly in patients over 65 years of age, with obesity, arterial hypertension, chronic lung diseases and immunosuppression states. Since the persistence of radiological imaging correlates with physiological deterioration, these patients are likely to be at increased risk of parenchymal lung disease.

It is known that the administration of Ozone, in any of the three phases of COVID-19 infection, is useful in the management of acute disease, both for its viricidal and anti-inflammatory activity, however, in the convalescence stage when the persistence of sequelae that can severely affect the quality of life of patients is identified.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ozone plasma

Detailed Description

The objective of this study is to evaluate whether the administration by inhalation of ozone plasma favorably modifies lung function and inflammatory parameters in patients with pulmonary sequelae associated with coronavirus 19 infection (SARS-COV-2). We will conduct an open-ended, uncontrolled clinical trial in 35 male and female patients, between 25-80 years of age with previous confirmed diagnosis of COVID-19 infection with negative nasopharyngeal polymerase chain reaction assay (PCR) test and without active disease, patients will also continue with their usual treatment. Clinical findings and laboratory and cabinet tests include a basal and 14-day metabolic and inflammatory profile, body weight, body mass index (BMI) and blood pressure will be determined during the initial and final visit, as well as respiratory parameters by pulmonary function tests (spirometry, TLCo) and performing the 6 min walk test in endless band with pre- and post-walk oximetry measurements at the beginning and end of the study. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U test and Wilcoxon exact test. A p <0.05 shall be considered statistically significant.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
    • Guadalajara, Jalisco, Mexico, 44340
      • Fernando Grover Paez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women
• 25-80 years
• Individuals without active disease with previous confirmed diagnosis of COVID-19 infection with negative nasopharyngeal PCR test
• With characteristic chest radiographic images compatible with lung infection, particularly interstitial pneumonitis with previous unburied glass patches, cobblestone or areas of consolidation (during active disease)
• Sign a letter of consent under information

Exclusion Criteria:

• Patients taking the following medicines: Ivermectin, azithromycin, corticosteroids, colchicine, chlorine dioxide, oral anticoagulants such as acenocoumarin, apixaban, rivaroxaban; bronchodilators such as β2-agonists such as salbutamol and derivatives, as well as inhaled anticholinergics of the ipratropium bromide type and derivatives.
• Patients who present medical difficulty or contraindication to perform the 6 km walk test in band
• Patients with a history of community-acquired pneumonia, pulmonary neoplasms, heart, renal, or hepatic failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ozone plasma; Patients will be provided with an ion-laden cold atmospheric plasma administration equipment from the company Fulgur Vitae Model 9000, they will also be given the necessary indications for the use of the equipment, which they must use for 5 minutes three consecutive times a day, every 6 hours, for two weeks. They will also be provided with an atmospheric oxygen meter, with the indication to keep the ppb below 0.07.

Drug: Ozone plasma; Patients will be provided with an ion-laden cold atmospheric plasma administration equipment from the company Fulgur Vitae Model 9000, they will also be given the necessary indications, as well as recommendations on the use of the equipment, which they must use for 5 minutes three consecutive times a day, every 6 hours, for two weeks. They will also be provided with an atmospheric oxygen meter, with the indication to keep the ppb below 0.07. You must record in your diary the start time, end and eventualities (in case of presenting them).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Function	Respiratory parameters by pulmonary function tests (spirometry, TLCo) and performing the 6 min walk test in endless band with pre- and post-walk oximetry measurements at the beginning and end of the study.	14 days
Inflammatory parameters	Inflammatory parameters by C reactive protein (CPR), Tumoral Necrosis Factor alfa (TNFa) and Interleukin 6 (IL-6) measurements at the beginning and end of the study.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Biometrics	Blood Biometrics at the beginning and end of the study.	14 days
Oxygen saturation	Oxygen saturation at the beginning and end of the study.	14 days
Ferritin	Ferritin at the beginning and end of the study.	14 days

Collaborators and Investigators

• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2021
• Primary Completion (Anticipated): November 25, 2022
• Study Completion (Anticipated): December 21, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Lung function; Plasma ozone; SARS CoV 2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CUCS-INTEC-OLFISA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No