Protocol summary
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Study aim
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Study of the effect of ozonated autohemotherapy in patients with severe covid-19
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Design
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A randomized open-label clinical trial with parallel intervention and control groups and 30 patients in each group.
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Settings and conduct
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This study will be done in Razi Hospital, Ahvaz, Iran. The control group will received only standard treatment and intervention group will received ozonated autohemotherapy in addition to standard treatment. This study will be open-labeled.
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Participants/Inclusion and exclusion criteria
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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: Coagulopathies and thrombocytopenia, history of seizure, hypothyroidism, pancreatitis, Hemophilias, acute alcohol poisoning, pregnancy and breast feeding, allergy to ozone or ozonated products.
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Intervention groups
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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 auto-hemotherapy: 200cc blood taken from the patient is mixed with 40cc of 30μg/mL ozone for 5 min then transfused back to the patient over 15 min.
The control group only receive the Iranian national protocol for treatment of Covid-19.
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Main outcome variables
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Length of hospital stay, need for ICU, duration of ICU stay, case fatality rate, ESR, CRPq, need for mechanical ventilation, duration of mechanical ventilation, changes in chest CT.
General information
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Reason for update
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We were faced with a prolongation in completion of servicing the ozonating device, therefore we postponed the patient admission process; in the meantime we added a supplementary explanation to the methods section in order better introduce the procedure to the reader unfamiliar with ozonating processes. Furthermore we decided to add to the secondary outcomes and increased the age upper limit from 70 to 75, the latter being due to a down-sloping of Covid19 patient prevalence in our province.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200616047792N1
Registration date:
2020-08-03, 1399/05/13
Registration timing:
prospective
Last update:
2020-08-16, 1399/05/26
Update count:
1
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Registration date
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2020-08-03, 1399/05/13
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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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2020-08-18, 1399/05/28
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Expected recruitment end date
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2020-09-20, 1399/06/30
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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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Study of intra-venous ozonated auto-hemotherapy on severe cases of COVID-19: A randomized clinical trial
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Public title
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A study of therapeutic effect of blood ozone therapy of severe Covid-19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization using https://www.sealedenvelope.com/
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2020-06-06, 1399/03/17
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Ethics committee reference number
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IR.AJUMS.REC.1399.217
Health conditions studied
1
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Description of health condition studied
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Covid-19
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ICD-10 code
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U07.1
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ICD-10 code description
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virus identified, Clinically-epidemiologically diagnosed COVID-19
Primary outcomes
1
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Description
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length of hospital stay
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Timepoint
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Daily since the time of hospitalization
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Method of measurement
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patient's file
Secondary outcomes
1
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Description
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Need for ICU
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Timepoint
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Daily since hospitalization
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Method of measurement
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Patient's file
2
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Description
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Duration of ICU stay
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Timepoint
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Daily since ICU stay
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Method of measurement
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Patient's file
3
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Description
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Need for mechanical ventilation
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Timepoint
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Daily since hospitalization
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Method of measurement
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Patient's file
4
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Description
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Duration of need for mechanical ventilation
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Timepoint
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Daily since mechanical ventilation
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Method of measurement
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Patient's file
5
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Description
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Case fatality rate
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Timepoint
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Daily since intervention
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Method of measurement
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Patient's file
6
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Description
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C-reactive protein
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Timepoint
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Thrice weekly
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Method of measurement
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Biochemistry method
7
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Description
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White blood cell count
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Timepoint
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Thrice weekly
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Method of measurement
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Cell counter
8
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Description
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Change in lung CT scan appearance
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Timepoint
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End of week one and week two
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Method of measurement
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Chest spiral CT scan
9
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Description
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ESR
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Timepoint
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Thrice weekly
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Method of measurement
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Biochemistry method
Intervention groups
1
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Description
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Control group: This group will receive the Iranian nationally implemented treatment protocol of Covid-19, which include any of the following, Hydroxychloroquine 200mg po BD or Chlroquine Phosphate 250mg po BD, Lopinavir-Ritonavir po 400-100mg BD, Atazanavir-Ritanavir 100-300mg po daily, IFN β-1a 44mcg sc EOD for 5-7 doses, IFN β-1b 250mcg sc EOD for 5-7 doses, Dexamethasone 8mg iv daily for ten days, Heparin 5000 u sc TDS or Enoxaparin 60u sc daiy.
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Category
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Treatment - Other
2
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Description
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Intervention Group: In the intervention group in addition to the Iranian nationally implemented protocol of Covid-19 treatment (which include any of the following, Hydroxychloroquine 200mg po BD or Chlroquine Phosphate 250mg po BD, Lopinavir-Ritonavir po 400-100mg BD, Atazanavir-Ritanavir 100-300mg po daily, IFN β-1a 44mcg sc EOD for 5-7 doses, IFN β-1b 250mcg sc EOD for 5-7 doses, Dexamethasone 8mg iv daily for ten days, Heparin 5000 u sc TDS or Enoxaparin 60u sc daiy) will receive a thrice weekly -up to two weeks- of ozonization of 200 cc of patient blood drawn and mixed with three 40ml draws (equivalent to 120ml) of 30μg/mL of ozone gas over 5 min which is then transfused back into patient's blood stream over15 minutes.
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Category
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Treatment - Other
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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Ahvaz 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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All related data will be provided upon completion of the study after disidentified IPD
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When the data will become available and for how long
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The related data will be indefinitely provided upon completion of the study.
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To whom data/document is available
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The related data will be provided to all interested upon completion of the study.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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This will be provided upon completion of the study. Contact: behnamshei@gmail.com
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What processes are involved for a request to access data/document
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Contact via email: behnamshei@gmail.com
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Comments
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