Protocol summary
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Study aim
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Determining the effect of Ozone Autohemotherapy on clinical and paraclinical features of patients with Covid10
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Documented Covid19 patients with age 20-60 years and admission to Intensive Care Unit
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Intervention groups
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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.
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Main outcome variables
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Complete Blood cell count and diffrential count, liver function tests and renal function test
General information
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Reason for update
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Updating the inclusion and exclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190618043923N4
Registration date:
2020-05-04, 1399/02/15
Registration timing:
registered_while_recruiting
Last update:
2023-05-13, 1402/02/23
Update count:
1
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Registration date
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2020-05-04, 1399/02/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-25, 1399/02/06
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Expected recruitment end date
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2020-06-20, 1399/03/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigation the effects medical Ozone Autohemotherapy on clinical and para clinical features of patients with Covid19
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Public title
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Ozone Autohemotherapy in Covid19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being 20-60 years of age
Having a positive reverse-transcriptase polymerase chain reaction test for SARS-CoV-2
Being admitted to the intensive care unit
Receiving invasive mechanical ventilation that began a short time before admission or in the intensive care unit
Exclusion criteria:
Patients with an anticipated survival length of fewer than 24 hours
Patients with a body mass index of 35 kg/m2 and over
Patients with a history of blood disorders
Patients with a history of renal or liver failure or chronic obstructive pulmonary disease
Pregnant or lactating women
Patients who were joined in other clinical trials
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-13, 1399/01/25
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Ethics committee reference number
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IR.TBZMED.REC.1399.022
Health conditions studied
1
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Description of health condition studied
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Coronavirus infection
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ICD-10 code
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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Complete Blood cell count and diffrential count
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Timepoint
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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
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Method of measurement
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Biochemical analysis
2
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Description
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Liver function tests
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Timepoint
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Liver function tests at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
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Method of measurement
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Biochemical analysis
3
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Description
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Renal function tests
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Timepoint
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Renal function tests at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of ozone autohemotherapy
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Method of measurement
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Biochemical analysis
Secondary outcomes
1
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Description
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Mechanical ventilator weaning time
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Timepoint
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Mechanical ventilator weaning time during the study after the start of ozone autohemotherapy
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Method of measurement
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Comment by the treating physician
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Common treatments
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available