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Comparison of the effectiveness and complication of dexamethasone at doses of 8 and 24 mg in the treatment of in Hospitalized Patients with Covid-19

Protocol summary

Study aim
Comparison of the effectiveness and complication of dexamethasone at doses of 8 and 24 mg in the treatment of in Hospitalized Patients with Covid-19
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 60 patients. A randomization table was used for randomization
Settings and conduct
This study is performed on patients with Covid 19 admitted to Al-Zahra Medical Center in Isfahan. After obtaining the consent of eligible patients, patients are divided into two groups using a randomization table, one group treated with dexamethasone at a dose of 8 mg daily for 10 days or until discharge and the other group treated with dexamethasone at a dose of 24 mg daily Up to 3 days and then 8mg daily for 7 days or until discharge. During treatment, fever, shortness of breath based on a modified Borg scale, the patient's O2sat level with and without oxygen therapy and tests such as quantitative CRP, LDH, ferritin, lymphocyte percentage, absolute neutrophil to lymphocyte ratio will be evaluated Drug side effects will be followed up.
Participants/Inclusion and exclusion criteria
Age over 18 years, evidence of SARS-CoV-2 virus by RT-PCR test, moderate to severe CTscan involvement, 80-93% O2sat level without oxygen therapy, at least 7 days after the onset of symptoms
Intervention groups
Injection of dexamethasone at a dose of 8 mg daily in the control group and injection of dexamethasone at a dose of 24 mg daily for up to 3 days in the intervention group and its change to 8 mg daily after 3 days
Main outcome variables
Efficacy and side effects of dexamethasone at doses of 8 and 24 mg

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190606043826N2
Registration date: 2021-07-01, 1400/04/10
Registration timing: prospective

Last update: 2021-07-01, 1400/04/10
Update count: 0
Registration date
2021-07-01, 1400/04/10
Registrant information
Name
Marzieh Mollaei Ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 0931
Email address
mollaei-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness and complication of dexamethasone at doses of 8 and 24 mg in the treatment of in Hospitalized Patients with Covid-19
Public title
Comparison of the effectiveness and complication of dexamethasone at doses of 8 and 24 mg in the treatment of in Hospitalized Patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized Patients with Covid-19
Exclusion criteria:
Pregnancy Immunodeficiency diseases chronic liver and kidney diseases or gastrointestinal bleeding Glucocorticoid use in the last 1 month
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants (they have no information about the type of drug injected) Responsible for data collection (on the data collection sheet, the name of the type of drug received by the patient is not mentioned) Data analyzer (in the data sent to the analyzer, the treatment groups are listed as A and B)
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-29, 1400/03/08
Ethics committee reference number
IR.MUI.MED.REC.1400.160

Health conditions studied

1

Description of health condition studied
covid 19 pneumonia
ICD-10 code
u10
ICD-10 code description
Multisystem inflammatory syndrome associated with COVID-19

Primary outcomes

1

Description
Determination of mean arterial blood oxygen saturation with and without oxygen therapy
Timepoint
At the beginning of hospitalization and 3, 5, 7 and 10 days later
Method of measurement
pulse oxymeter

2

Description
Shortness of breath score based on modified Borg scale
Timepoint
At the beginning of hospitalization and 3, 5, 7 and 10 days later
Method of measurement
modified Borg scale

3

Description
Number of days required for mechanical ventilation
Timepoint
daily
Method of measurement
Counting days under mechanical ventilation

4

Description
Measurement of serum levels of C-reactive protein
Timepoint
At the beginning of hospitalization and 3, 5, 7 and 10 days later
Method of measurement
laboratory test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with covid 19 treated with dexamethasone 24 mg daily for 3 days and then 8 mg daily for 10 days or until discharge
Category
Treatment - Drugs

2

Description
Control group: Patients with Covid 19 who are treated with dexamethasone 8 mg daily for 10 days or discharge time
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital, Isfahan
Full name of responsible person
Somayeh Sadeghi Haddad Zavareh
Street address
Al-Zahra Hospital , Sofa Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Sadeghi Haddad Zavareh
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Isfahan 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
Somayeh Sadeghi Haddad Zavareh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
S.sadeghi117917@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Sadeghi Haddad Zavareh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
S.sadeghi117917@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Sadeghi Haddad Zavareh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
S.sadeghi117917@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
After analyzing the results, the data access period is free
To whom data/document is available
Academic Institutions and Researchers
Under which criteria data/document could be used
For use in future studies.
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
Send an email to the author and get the information
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