Evaluation of Dexamethasone effects on improvement of Iranian COVID-19 patients
Design
This study is a clinical trial with a control group, with single blind double-sided groups in the second phase. Which will be performed on 200 outpatients with COVID-19 disease. Patients are randomly divided into two groups of intervention and placebo based on the method of Permuted balanced block randomization and according to the patient file number.
Settings and conduct
A total of 200 outpatients with COVID-19 with respiratory symptoms referred to clinics in Imam Khomeini, Amir-Alam, Emam Ali and Ziaian hospitals are enrolled.
Participants/Inclusion and exclusion criteria
Patients with Covid 19 who test positive for SARS-CoV-2 by RT-PCR or diagnosed by CT scan criteria and saturated oxygen between 95-90% are randomly entered into the study.
Exclusion criteria: Having a history of underlying diseases such as diabetes, malignancies, renal and heart failure, uncontrolled hypertension, other active infections, use of immunosuppressive drugs and corticosteroids, pregnant women or breastfeeding
Intervention groups
Control group: will receive standard regimen for COVID-19. Dexamethasone group: will receive standard regimen for COVID-19 plus 8 mg Dexamethasone (If the patient's condition does not change, the dose will repeat after 48 hours).
Main outcome variables
Clinical symptoms including: mortality rate, blood oxygen saturation level, need for oxygen therapy and laboratory tests before and one and two weeks after treatment will be evaluated and recorded in a questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201015049030N1
Registration date:2020-11-07, 1399/08/17
Registration timing:registered_while_recruiting
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Mohammadreza Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2811
Email address
mr-salehi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-11, 1399/06/21
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Dexamethasone effects on the improvement of clinical symptoms and laboratory signs of Iranian COVID-19 patients: a clinical trial study
Public title
Effect of Dexamethasone on treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatients with Covid 19 confirmed by positive PCR test for SARS-CoV-2 or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities),
With blood oxygen saturation between 90-95%
Patients with severe respiratory symptoms such as cough, shortness of breath and severe shortness of breath or CRP above 20 or after three days of standard treatment worsened symptoms of the disease, including exacerbated fevers, aggravated weakness or aggravated shortness of breath based on the physician's clinical judgment
Exclusion criteria:
Patients with a history of underlying disease such as diabetes, malignancies, renal and heart failure, uncontrolled hypertension, and taking immunosuppressive drugs and corticosteroids
Patients with other active infections
Pregnant or lactating women
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to the intervention and control groups will be done based on the Permuted balanced block randomization method and according to the patients' file numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study patients don't know which group of them will use the medicine. Physician and clinicians team know about the medicine and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs Tehran University of Medical Science
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-09-10, 1399/06/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.432
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
U07.2, U07
ICD-10 code description
COVID-19
Primary outcomes
1
Description
O2 saturation
Timepoint
Before, one and two weeks after dexamethasone treatment
Method of measurement
Pulse Oximeter
2
Description
Mortality rate
Timepoint
Before and after dexamethasone treatment
Method of measurement
Observation
3
Description
Need for an oxygen therapy
Timepoint
Before and after dexamethasone treatment
Method of measurement
Clinical
4
Description
Constitutional
Timepoint
Before, one and two weeks after dexamethasone treatment
Method of measurement
Clinical
5
Description
Needs of hospitalization
Timepoint
Before and after treatment
Method of measurement
Observation
Secondary outcomes
1
Description
CRP laboratory test
Timepoint
Before, one and two weeks after dexamethasone treatment
Method of measurement
Para-clinical
2
Description
CBC laboratory test
Timepoint
Before, one and two weeks after dexamethasone treatment
Method of measurement
Para-clinical
Intervention groups
1
Description
Intervention group: 100 outpatients with Covid 19 with respiratory symptoms who in addition to their standard treatment will receive 8mg Dexamethasone (If patient's condition does not change, the dose will repeat after 48 hours).
Category
Treatment - Drugs
2
Description
Control group: 100 outpatients with Covid 19 with respiratory symptoms who are received standard treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Mohamadreza Salehi
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1594
Email
salehi.mohamad3@gmail.com
2
Recruitment center
Name of recruitment center
Ziaeian
Full name of responsible person
Saeed Reza Jamali Moghadm
Street address
Tehran Province, Tehran, Ghaleh Marghi St., Abuzar St., District 17 Municipality, No.
City
Tehran
Province
Tehran
Postal code
3651113667
Phone
+98 21 5517 6813
Email
saeedjamali@yahoo.com
3
Recruitment center
Name of recruitment center
Amir-Alam Hospital
Full name of responsible person
Ali Asadolahi Amin
Street address
North Sadi Street, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
6511111457
Phone
+98 21 6670 6106
Email
asadollahia@sina.tums.ac.ir
4
Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Mojtaba Hedayat Yaghoobi
Street address
Emam Ali Hospital, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3256 2358
Email
hyaghooby@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohamadreza Salehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1594
Email
salehi.mohamad3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Mahmoudi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8822 0067
Email
mahmoudim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Akhtari
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8822 0067
Email
m.akhtari@ut.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
t will be published as an article
When the data will become available and for how long
After printing the article
To whom data/document is available
All medical professionals and scientiscts
Under which criteria data/document could be used
There is no restriction on access to information
From where data/document is obtainable
Dr. Mohamad Reza Salehi, Tehran University of Medical Science
What processes are involved for a request to access data/document