Study of the effect of ozonated autohemotherapy in patients with severe covid-19
Design
A randomized open-label clinical trial with parallel intervention and control groups and 30 patients in each group.
Settings and conduct
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.
Participants/Inclusion and 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: Coagulopathies and thrombocytopenia, history of seizure, hypothyroidism, pancreatitis, Hemophilias, acute alcohol poisoning, pregnancy and breast feeding, allergy to ozone or ozonated products.
Intervention groups
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 3-5 min then transfused back to the patient.
The control group only receive the Iranian national protocol for treatment of Covid-19.
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:IRCT20200616047792N1
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2020-08-03, 1399/05/13
Update count:1
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Behnam Sheibani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 5312
Email address
behnamshei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of intra-venous ozonated auto-hemotherapy on severe cases of COVID-19: A randomized clinical trial
Public title
A study of therapeutic effect of blood ozone therapy of severe Covid-19 patients
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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using https://www.sealedenvelope.com/
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 Ahvaz Jundishapur University of Medical Sciences
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.
Category
Treatment - Other
2
Description
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 trice weekly -up to two weeks- of ozonization of 200 cc of patient blood drawn and mixed with 40ml of 30 μg/mL of ozone gas for 15 minutes which is then transfused back into patient's blood stream.
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
Behnam Sheibani
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
Fax
Email
behnamshei@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 Blvd, Ahvaz
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
Behnam Sheibani
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
Fax
Email
behnamshei@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
The related data will be provided to all interested 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: behnamshei@gmail.com
What processes are involved for a request to access data/document