Ozone Therapy for Covid 19 Pneumonia PatientsNCT04789395
Evaluation of Post-covid 19 Patients Who Receive Ozonetheraphy With Thorax CT
An observational study of Ozone Therapy for Covid 19 Pneumonia Patients, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ozone Therapy for Covid 19 Pneumonia Patients
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2020to 20 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25 patients over 18 years of age, treated with ozone in ICU and wards
Who may be able to join
- over 18 years covid 19 pneumonia patients who have ground glass opacity on thorax CT, receiving ozone as adjuvant therapy.
Who cannot join
- pregnant patients patients who doesnt treated with ozone(hyperthyroid,pulmonary hypertension, right ventricule failure,glucose 6 P dehydrogenase defficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa TREH
Istanbul, Gaziosmanpaşa, 34255
aygen türkmen, MD.prof., +902129453000 ext. 1436, aygenturkmen@hotmail.com
zuhal çavuş, MD
About this study
Official title: Clinical Determination of Patients Who Intersive Care Unit and Clinical Ttreatments Have Finished Receive Ozonetheraphy With Thorax Tomography Regarding to Interstisial Fibrosis
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.
Read the detailed description
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.
- Keywords
- ozone, COVİD 19, pulmonary fibrosis
- Medical subject headings
- COVID-19, Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of pulmonary fibrosis in covid 19 pneumonia patients with ozone therapy
Ozone as an additional therapy can reduce the fibrosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start2 Sep 2020
- Primary completion20 Sep 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ozone Therapy for Covid 19 Pneumonia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SİBEL BEKTAŞ, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789395
- Sponsor's protocol ID
- 08.092.r1.125
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Determination of Patients Who Intersive Care Unit and Clinical Ttreatments Have Finished Receive Ozonetheraphy With Thorax Tomography Regarding to Interstisial Fibrosis
- ClinicalTrials.gov ID
- NCT04789395
- Acronym / sponsor ID
- 08.092.r1.125
- Keywords
- ozone, COVİD 19, pulmonary fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients over 18 years of age, treated with ozone in ICU and wards
Key inclusion criteria (1 listed)
- over 18 years covid 19 pneumonia patients who have ground glass opacity on thorax CT, receiving ozone as adjuvant therapy.
Key exclusion criteria (1 listed)
- pregnant patients patients who doesnt treated with ozone(hyperthyroid,pulmonary hypertension, right ventricule failure,glucose 6 P dehydrogenase defficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevention of pulmonary fibrosis in covid 19 pneumonia patients with ozone therapy
Time frame: 1 year
Ozone as an additional therapy can reduce the fibrosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ozone Therapy for Covid 19 Pneumonia Patients, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of pulmonary fibrosis in covid 19 pneumonia patients with ozone therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.