Protocol summary

Study aim
Investigating the effect of ozone therapy on pulmonary sequels in patients with COVID-19 and the resulting hypoxia
Design
Clinical trial with control and intervention groups, with parallel groups, without blinding, randomized, phase 2 on about 100 patients. Block randomization method will be used for randomization.
Settings and conduct
Place of study: Ozone therapy centers affiliated to BaqiyatAllah University located in Tehran and Najaf Abad. Study population: patients referred to the mentioned centers; Type of blinding: none
Participants/Inclusion and exclusion criteria
Inclusion criteria: Filling out the informed consent form; post COVID-19 oxygen dependent patients. Exclusion criteria: hypersensitivity to ozone; Albumin less than 3.4; Bleeding and coagulation disorders; Platelets less than 60,000; Uncontrolled hyperthyroidism
Intervention groups
Intervention group: The intervention of these patients will be with a therapeutic dose of 35-50 micrograms/ml with O2/O3 mixture based on the inflammatory factors and severity of pulmonary involvement at the time of referral. Control group: patients referred to the hospital/clinic who receive only standard treatment.
Main outcome variables
lung CT scan reports ,saturation of blood O2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220814055690N1
Registration date: 2024-03-22, 1403/01/03
Registration timing: prospective

Last update: 2024-03-22, 1403/01/03
Update count: 0
Registration date
2024-03-22, 1403/01/03
Registrant information
Name
sina abbaspour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4277 3001
Email address
sina.abbaspour75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the consequences of ozone therapy in hypoxia of oxygen-dependent patients affected by COVID-19 after discharge from the hospital
Public title
Effect of ozone therapy in post COVID-19 lung sequels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Filling out the informed consent form Post COVID-19 oxygen dependent patients
Exclusion criteria:
Hypersensitivity to ozone Albumin less than 3.4 Platelets less than 60,000 Bleeding and coagulation disorders Uncontrolled hyperthyroidism
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 206
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted (block randomization). Based on this method, the patients are categorized and equal number of participants are entered into the intervention and control groups at consecutive but equal time intervals. In this way, for example, one type of treatment is given to the first block, another type is given to the second, and again the first type is given to the third block and so on.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah hospital, Sheikh Bahayi Ave., Mollasadra Ave., Vanak square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.095

Health conditions studied

1

Description of health condition studied
Post COVID fibrosis/ inflammatory lung disease
ICD-10 code
R91
ICD-10 code description
Abnormal findings on diagnostic imaging of lung

2

Description of health condition studied
COVID-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
The percentage of improvement of pulmonary involvement in CT scan reports of patients
Timepoint
At the beginning of the study and 6 months after the received treatment
Method of measurement
CT scan report of patients

2

Description
Spirometry diagram
Timepoint
At the beginning of the study and 6 months after the received treatment
Method of measurement
Interpretation of spirometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients referred to ozone therapy centers affiliated to Baqiyatullah University located in Tehran and Najaf Abad, with a history of contracting COVID-19, who have been discharged from hospital with hypoxemia and oxygen dependency, will be included in the study. The therapeutic dose is 35-50 micrograms/mL with a volume of 120-240 cc of blood and its equivalent O2/O3 mixture for 5-20 sessions, based on the inflammatory factors and severity of lung involvement and hypoxia at the time of referral, the exact amount of the dose and the number of sessions is selected. The first sessions will be daily and then alternate in the week.
Category
Treatment - Other

2

Description
Control group: This group receives standard treatment including prednisolone or pirfenidone. These patients were admitted to the hospital and referred to the relevant medical centers and received appropriate treatment and were included in the study under the name of control group. Normally, the dose of Pirfenidon for the first week is 267 mg daily, for the second week, 534 mg, and from the third week (maintenance treatment) 801 mg. Maintenance treatment is selected based on the condition and severity of the patient's involvement. Prednisolone is usually 1mg/kg daily, which can be changedbased on the patient.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Najafabad ozone therapy center
Full name of responsible person
Dr. Morteza Izadi
Street address
ozone therapy center, No.4, west 17 Shahrivar Ave., Najaf Abad
City
Isfahan
Province
Isfehan
Postal code
8581173441
Phone
+98 31 4261 1700
Email
Sina.Abbaspour75@gmail.com

2

Recruitment center
Name of recruitment center
Tehran Baqiyatollah ozone therapy center
Full name of responsible person
Dr. Morteza Izadi
Street address
Arya Physicians building, next to Baqiyatolla hospital, Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 6515
Email
Sina.Abbaspour75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Hossein Kachouyi
Street address
Vice President of Research and Technology, Baqiyatullah University, Molla Sadra Ave., Sheikh Bahayi Ave., Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
Sina.Abbaspour75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Sina Abbaspour
Position
Substitute executor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Baqiyatollah University,Sheikh Bahayi Ave, Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
5493153491
Phone
+98 13 4277 3001
Email
Sina.abbaspour75@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Morteza Izadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Baqiyatollah University,Sheikh Bahayi Ave, Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
morteza_izadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sina Abbaspour
Position
soldier
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 52, Shahidan Amini Ave., Hezar Jirib Blvd.
City
Isfahan
Province
Isfehan
Postal code
4493153491
Phone
+98 921 168 9277
Email
Sina.Abbaspour75@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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