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

COVID-19 Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05089305
• Other study ID #: CUCS-INTEC-OLFISA-001
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: September 4, 2021
• Est. completion date: December 21, 2022

Study information

• Verified date: November 2021
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: December 21, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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 ß2-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

Related Conditions & MeSH terms

• COVID-19

Intervention

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).

Locations

Country	Name	City	State
Mexico	Fernando Grover Paez	Guadalajara	Jalisco
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood Biometrics	Blood Biometrics at the beginning and end of the study.	14 days
Secondary	Oxygen saturation	Oxygen saturation at the beginning and end of the study.	14 days
Secondary	Ferritin	Ferritin at the beginning and end of the study.	14 days