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

NCT05089305 | Unknown Phase 2

• 1 other identifier: CUCS-INTEC-OLFISA-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19

Keywords

Plasma ozone; COVID-19; SARS CoV 2; Lung function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Blood Biometrics

  14 days

• Oxygen saturation

  14 days

• Ferritin

  14 days

Study Arms (1)

Ozone plasma

EXPERIMENTAL

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

Interventions

Ozone plasma DRUG

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).

Ozone plasma

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Fernando Grover Paez

Guadalajara, Jalisco, 44340, Mexico

Location

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-ended, uncontrolled clinical trial in 35 patients

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 22, 2021
• Study Start: September 4, 2021
• Primary Completion: November 25, 2022
• Study Completion: December 21, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)