Protocol summary

Study aim
Determining the effect of Ozone Autohemotherapy on clinical and paraclinical features of patients with Covid10
Design
A controlled clinical trial, with parallel groups, single-blinded, randomized, phase 2 on 20 patients. RAS (Random Allocation Sofware) software will be used for randomization.
Settings and conduct
Twenty 20-60 years old patients with Covid19 who are admitted to the intensive care unit will be entered the study using the convenient sampling method and will be randomly allocated into two groups to receive 1) Ozone Autohemotherapy with conventional therapies or 2) conventional therapies. Autohemotherapy will be given three times a week for 10 times in total.
Participants/Inclusion and exclusion criteria
Documented Covid19 patients with age 20-60 years and admission to Intensive Care Unit
Intervention groups
Ozone Autohemotherapy, Injection of 100 ml of ozone at a concentration of 30micro / mL O2-O3 mixed with 100ml of patient's own heparinized blood will be given three times a week for a total of 10 times.
Main outcome variables
Complete Blood cell count and diffrential count, liver function tests and renal function test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043923N4
Registration date: 2020-05-04, 1399/02/15
Registration timing: registered_while_recruiting

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
aghamohammadi.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-25, 1399/02/06
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects medical Ozone Autohemotherapy on clinical and para clinical features of patients with Covid19
Public title
Ozone Autohemotherapy in Covid19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Documented Covid19 patients With age 20-60 years Admission to Intensive Care Unit
Exclusion criteria:
History of blood disorders History of liver failure History of renal failure History of chronic obstructive pulmonary disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS). Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, data collection officials, those who evaluate the outcome and the person responsible for data analysis will be blinded to random allocation of participants to study groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3692588521
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.TBZMED.REC.1399.022

Health conditions studied

1

Description of health condition studied
Coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Complete Blood cell count and diffrential count
Timepoint
Complete Blood cell count and diffrential count at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
Method of measurement
Biochemical analysis

2

Description
Liver function tests
Timepoint
Liver function tests at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
Method of measurement
Biochemical analysis

3

Description
Renal function tests
Timepoint
Renal function tests at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
Method of measurement
Biochemical analysis

Secondary outcomes

1

Description
Mechanical ventilator weaning time
Timepoint
Mechanical ventilator weaning time during the study after the start of ozone autohemotherapy
Method of measurement
Comment by the treating physician

Intervention groups

1

Description
Intervention group: Major Autohemotherapy with common treatments. 100 ml of the patient heparinized blood is mixed with 100 ml of ozone at a concentration of 30micro /mL O2-O3 and injected again. These injections are given 3 times a week for a total of 10 times.
Category
Treatment - Drugs

2

Description
Control group: Common treatments
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3692588521
Phone
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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