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Evaluating the effectiveness of intravenous ozonized saline in treatment of severe COVID-19 disease: A randomized Control trial

Protocol summary

Study aim
Study of intra-venous ozonated normal saline on severe cases of COVID-19
Design
Randomised, superiority, parallel group trial, double blind, outcome assessment.phase 3. block randomization on 60 patient.
Settings and conduct
At the beginning of patients' referral to Razi Hospital in Ahvaz, if they have inclusion criteria, they will be included in the study. 400 ml of normal saline is ozonated by 40 micrograms per kilogram of patient body weight Ozone produced by the Medozon device. The concentration of ozone in normal saline with this method is 5 mic / ml and is injected into the patient within 15 to 30 minutes (80 to 120 drops per minute). This is done daily every morning for a week. All patients are monitored for general health status up to two weeks after the end of the protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria are Severe cases of Covid-19 with chest CT changes in the form of peripheral uni- or bilateral ground glass opacity(s) in combination with any of the below: RR greater than 24, O2 Sat less than 93%, BP less than 90/60, decreased level of consciousness. Exclusion criteria are G6PD Deficiency Coagulopathies and thrombocytopenia Hx of seizure Hypothyroidism Pancreatitis Hemophilias Acute alcohol poisoning Pregnancy and breast feeding Allergy to ozone and ozonated products
Intervention groups
The intervention group is patients who have received corona treatment according to the protocol, and in addition we give these people ozonated normal saline. The control group received corona treatment according to the protocol and normal saline that isn't ozonated
Main outcome variables
Lenth of hospital stay, need for ICU, duration of ICU stay, case fatality rate, PaO2/FiO2, need for mechanical ventilation, duration of mechanical ventilation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200730048253N1
Registration date: 2020-08-08, 1399/05/18
Registration timing: prospective

Last update: 2020-08-08, 1399/05/18
Update count: 0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Najmeh Dareini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 5935
Email address
www.e24267s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of intravenous ozonized saline in treatment of severe COVID-19 disease: A randomized Control trial
Public title
Evaluating the effectiveness of intravenous ozonized saline in COVID-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe cases of Covid-19 with chest CT changes in the form of peripheral uni- or bilateral ground glass opacity(s) in combination with any of the below: RR greater than 24, O2 Sat less than 93%, BP less than 90/60, decreased level of consciousness.
Exclusion criteria:
G6PD Deficiency Coagulopathies and thrombocytopenia Hx of seizure Hypothyroidism Pancreatitis Hemophilias Acute alcohol poisoning Pregnancy and breast feeding Allergy to ozone and ozonated products
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with blocks with size of 6 and by the means of https://www.sealedenvelope.com/
Blinding (investigator's opinion)
Double blinded
Blinding description
Except of investigator, all of participants in the study wont be aware of the group treatment of the patient and they wont know the patient are in ozonated normal saline or normal saline alone
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
golestan st,
City
َAhvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.AJUMS.REC.1399.363

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
Daily Since hospitalization
Method of measurement
patient's file

Secondary outcomes

1

Description
Need for ICU
Timepoint
daily since hospitalization
Method of measurement
patient's file

2

Description
Duration of ICU stay
Timepoint
Daily since ICU stay
Method of measurement
Patient's file

Intervention groups

1

Description
Intervention group: The intervention group will receive the Iranian national protocol treatment of Covid-19 (which include any of the following, Hydroxychloroquine or Chlroquine Phosphate, Lopinavir-Ritonavir, Atazanavir-Ritanavir, IFN β-1a, IFN β-1b, Dexamethasone, Heparin or Enoxaparin) in addition to a thrice weekly ozonated normal saline Thus, 400 ml of normal saline is ozonated by 40 micrograms per kilogram of body weight of the patient by Medozon device within ten minutes (ozone concentration in normal saline with this method is 5mic / ml) and within 15 minutes It is injected into the patient for 30 minutes (80 to 120 drops per minute). This is done daily every morning for a week
Category
Treatment - Other

2

Description
Control group: The control group will receive the Iranian national protocol treatment of Covid-19 (which include any of the following, Hydroxychloroquine or Chlroquine Phosphate, Lopinavir-Ritonavir, Atazanavir-Ritanavir, IFN β-1a, IFN β-1b, Dexamethasone, Heparin or Enoxaparin) and normal saline that is not ozonated. Taking normal saline is daily for a week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
RAZI HOSPITAL
Full name of responsible person
Dr.Najme dareini
Street address
Felestin Blvd
City
AHVAZ
Province
Khouzestan
Postal code
61965114941
Phone
+98 61 3392 5312
Email
e24267s@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. mohammad Badavi
Street address
Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
dr.mohammadbedoui@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
najme dareini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
felestin blvd
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3392 5312
Email
e24267s@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokrollah Salmanzadeh Ramhormozi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Felestin bolvd
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3392 5312
Email
salmanidmd@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Najme Dareini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Felestin blvd
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3392 5312
Email
e24267s@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All related data will be provided upon completion of the study after disidentified IPD
When the data will become available and for how long
The related data will be indefinitely provided upon completion of the study.
To whom data/document is available
Relevant information will be provided to all interested parties for humanitarian study and research purposes upon completion of the study.
Under which criteria data/document could be used
On the condition that if any of the study methods (including study design and implementation method, measurement methods, etc.) are used the copyright law be observed and our study be cited.
From where data/document is obtainable
This will be provided upon completion of the study. Contact: e24267s@gmail.com
What processes are involved for a request to access data/document
Contact via email: e24267s@gmail.com
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