The purpose of this study will to evaluate the role of regional hyperthermia of the chest wall on the oxygen saturation of Covid-19 patiens who suffer from lung disorders as a result of this disease to find a way inactivate covid-19 viruses.
Design
َAfter using hyperthermia for the studied patients, blood O2 saturation and the size of their lung lesions will evaluate.
Settings and conduct
The study will perform on the Sayed-Al-Shohada hosptal, Isfahan, Iran.
The studied patients will undergo regional hyperthermia, and the size of their lungs lesions and also blood O2 saturation will evaluate based on their CT scan data and blood O2 measurement systems.
Participants/Inclusion and exclusion criteria
requirements to include this study:
The patients age > 17
Positive PCR test of nasopharynx or oropharynx
No sign of underlying disease such as auto immunity disorders.
No sign of diabetes
No sign of lung cancer and also other underlying disease
SPO2 ( 85%-90%) , with out using external oxygen sources.
requirements to exclude this study:
The patients age > 75
SAO2 decrease in 48 hours after regional hyperthermia.
Intervention groups
Hyperthermia in experimental group with prescribed drugs from Iranian Ministry of Health.
Main outcome variables
Blood O2 Saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201122049463N1
Registration date:2021-01-18, 1399/10/29
Registration timing:prospective
Last update:2021-01-18, 1399/10/29
Update count:0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
Hossein Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3771 5973
Email address
htaheri232@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-10, 1399/11/22
Actual recruitment start date
2021-01-20, 1399/11/01
Actual recruitment end date
2021-02-10, 1399/11/22
Trial completion date
2021-03-10, 1399/12/20
Scientific title
The effect of chest wall hyperthermia on the blood oxygen saturation of Covid-19 patients who suffered from lung disease
Public title
The effect of chest wall hyperthermia on the blood oxygen saturation of Covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive nasopharyngeal or oropharyngeal PCR test
No sign of underlying disease such as auto immunity disorders
No sign of diabetes
No sign of lung cancer
SPO2 ( 85%-90%) , with out using external oxygen sources.
Exclusion criteria:
Patient's age > 75
SAO2 decrease 48 hours after local hyperthermia
Age
From 17 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-BA- A-B-B, respectively. Finally, group A receives control intervention and group B receives treatment intervention
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
Research ethical committe of Medical School, Medical University of Isfahan, Iran.
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-03, 1399/08/13
Ethics committee reference number
IR.MUI.MED.REC.1399.684
Health conditions studied
1
Description of health condition studied
Covid-19 Pneumonia
ICD-10 code
U07.1
ICD-10 code description
covid-19, virus identified
Primary outcomes
1
Description
Blood oxygen saturation
Timepoint
1 hour before start the study, 1 hour after start the study, 1 times per 6 hours
Method of measurement
Oxygen saturaion system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Covid-19 patients who suffered from Covid19 pneumonia, hospitalized and recieved National Pharmaceutical Protocol,will undergone hyperthermia via RF device,2 times daily for 30 minutes during 72 hours
Category
Treatment - Devices
2
Description
Control group: Covid-19 patients who suffered from Covid19 pneumonia,hospitalized and recieved National Pharmaceutical Protocol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayed- AL- Shohada hospital
Full name of responsible person
Mohammadbagher Tavakoli
Street address
Motaheri st.
City
Isfahan
Province
Isfehan
Postal code
8187644465
Phone
+98 31 3792 9032
Email
mb.tavakoli@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjooy
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadbagher Tavakoli
Position
Head of Medical Physics department, Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8187655541
Phone
+98 31 3792 9032
Email
mb.tavakoli@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadbagher Tavakoli
Position
Head of Medical physics department, Isfahan University of medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8187655541
Phone
+98 31 3792 9032
Email
mb.tavakoli@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Taheri
Position
researcher
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8187655541
Phone
+98 31 3792 9032
Email
htaheri232@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
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
Title and more details about the data/document
The all of above mentioned choices, which selected to spread their results, will report to Isfahan University of Medical sciences.
When the data will become available and for how long
March
To whom data/document is available
The research scientific committee of Isfahan University of Medical sciences.
Under which criteria data/document could be used
Regard to the research scientific committee request.
From where data/document is obtainable
Prof. Dr. Mohammadbagher Tavakoli, Medical Physics department, Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
According to approve process from reseach committee of Isfahan University of Medical sciences.