Studying the therapeutic effect and side effects of dexamethasone in COVID-19 positive patients with mild to moderate symptoms
Design
Clinical trial with parallel randomized groups
Settings and conduct
This is a randomized clinical trial which will be done at Dr. Masih Daneshvari Hopital
Participants/Inclusion and exclusion criteria
In this study, 18 year old patients with confirmed COVID-19 through RT-PCR, who signed consent form, were included in the study. Furthermore, patients with PiO2/FiO2 between 100 and 300 mmHg, and bilateral lung infiltration with mild to moderate symptoms were included. Patients with acute and chronic renal disease, liver disease, hyperglycemia, with sever symptoms were excluded from this study.
Intervention groups
Patients in treatment group received dexamethasone (manufactured by Abouraihan Pharmaceutical Company) 20 mg intravenously from day one to 5 then 10 mg for days 6 to 10. patients in control group did not receive dexamethasone. patients in both groups received oxygen, fluid support, and lopinavir/ritonavir 200/50 mg to Tab BID as standard therapy.
Main outcome variables
Need of mechanical ventilation and death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N17
Registration date:2020-05-31, 1399/03/11
Registration timing:retrospective
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-24, 1399/02/05
Expected recruitment end date
2020-05-25, 1399/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evolution of the efficacy and safety of Dexamethasone administration in patients with mild to moderate COVID-19 acute respiratory disease syndrome
Public title
Evolution of the efficacy and safety of Dexamethasone administration in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 65 years old
Laboratory COVID-19 confirmed with RT-PCR
Mild to moderately ill patients
Patients with PaO2/FiO2 between 100-300
Signed the consent form
Exclusion criteria:
Acute or chronic renal impairment (Creatinin rise more than 3 units in the last 48 hours and/or GFR less than 30 mL/min)
Chronic liver disease (Rise in LFTs more than 5 times and/or 3 times rise in LFTs in symptomatic patients and/or Child pugh C,D)
Allergy to corticosteriods while being injected with extravasation and signs of anaphylactic shock.
Patients with hyperglycemia
Pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study. 12 blocks including 4 patients generated with online website (www.sealedenvelope.com). In each block, two patients will be assigned to Dexamethasone group and two patients will be assigned to control group.
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
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-04-22, 1399/02/03
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.071
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
Need for invasive mechanical ventilation
Timepoint
Daily
Method of measurement
Medical record
2
Description
Death
Timepoint
At the end of the study
Method of measurement
Medical record
Secondary outcomes
1
Description
Weaning from oxygen support
Timepoint
Daily
Method of measurement
Medical record
2
Description
Length of hospital stay
Timepoint
At the end of the study
Method of measurement
Medical record
3
Description
Lung radiology changes
Timepoint
At admission time and seven and 14 days later
Method of measurement
At admission time and seven and 14 days later
Intervention groups
1
Description
Intervention group: Patients in dexamethasone group receive intravenous dexamethasone (manufactured by Abouraihan Pharmaceutical Company) at dose of 20 mg/day for day's one to five and then 10 mg/day for day's 6 to 10. Also patients receive supportive treatments including oxygen therapy and fluid therapy. According to the national guideline, patients receive Lopinavir/ritonavir tablets (Hetered Pharmaceutical Company, India) at dose of 200/50 mg in two tablets per day.
Category
Treatment - Drugs
2
Description
Control group: Patients receive supportive treatments including oxygen therapy and fluid therapy. Also, according to the national guideline, patients receive Lopinavir/ritonavir tablets (Hetered Pharmaceutical Company, India) at dose of 200/50 mg in two tablets per day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Payam Tabarsi
Street address
Daraabad, Shahid Bahonar St. (Niavaran), Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
payamtabarsi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammadreza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2486
Email
iran.criticalcare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor, Clinical Pharmacy Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St., Intersection of Niyayesh Highway, Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
f_dastan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Mirshafiei Langari
Position
Hospital pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2066
Email
z.mirshafei@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
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
Undecided - It is not yet known if there will be 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
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Researchers can meet Dr. farzaneh Dastan at Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran or request data via email: fzh.dastan@gmail.com
What processes are involved for a request to access data/document