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Evaluation of Post-covid 19 Patients Who Receive Ozonetheraphy With Thorax CT

Study Purpose

It is known that enhances wound healing by oxidative stress and supports immune system besides it is cheap and has not any side effects. Aim of the study is to prevent pulmonary fibrosis by using ozone therapy as a supportive therapy on the patients who have pneumonia and ground glass opacity on thorax CT both in ICU and wards. Patients will follow for a year.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- over 18 years covid 19 pneumonia patients who have ground glass opacity on thorax CT, receiving ozone as adjuvant therapy.

Exclusion Criteria:

- pregnant patients patients who doesnt treated with ozone(hyperthyroid,pulmonary hypertension, right ventricule failure,glucose 6 P dehydrogenase defficiency

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04789395
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Gaziosmanpasa Research and Education Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Turkey
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ozone Therapy for Covid 19 Pneumonia Patients

Additional Details

The patients accepted with the diagnosis of pneumonia in Gaziosmanpaşa TREH, both in ICU and wards have treated with additional ozone therapy beside the normal treathments. In these patients the findings like ground glass opacity in thorax CT regarding to covid 19 were progressed or non changed. In the concern of these opacities turn to pulmonary fibrosis, ozone therapy has used to prevent this undesirable effect. It is known that enhances wound healing by oxidative stress and supports immune system besides it is cheap and has not any side effects. 25 patients included this study. The patients were diagnosed with Covid-19 pneumonia and treated with ozone therapy in intensive care unit and ward. After treatment was done, findings of at least %20-25 ground-glass opacity on thorax ct were the main criteria for enrollment. The patients' follow-up program time after hospital discharge will be on 1st, 3rd, 6th and 12th month. They will continue to recieve ozon therapy once in a month during one year follow up. Ground-glass opacity rate of thorax ct scan will be recorded as less then %25, %25-50, %50-75 and above %75. Tomographies will be compared with each other and also last thorax ct before hospital discharge. These tomographies will be applied under 80 KV and this will give %40 less dosage according to routine 120 KV scans. If there is an increase in ground-glass opacities compared to the previous one, the scan will be done again on prone position and suspected lesions will be reevaluated. The pulmonary fibrosis findings of the scan will be diagnosed by a well trained radiology doctor. The evaluation of dyspnea will also done during follow-ups. mMRC(medical research council) dyspnea scale will be used for dyspnea status. SpO2 values in room-air will also recorded. FEV1, FVC and FEV1/FVC values will also be recorded to demonstrate respiratory functions.

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