effect of meformin in any need to hospitalization, ARDS symptoms and mortality in patients with COVID-19
Design
The randomized clinical trial with a parallel group design in which 200 patients will be enrolled between 20 March 2020 till 18 April 2020
Settings and conduct
This study will be performed in outpatient clinic of corona of tabriz university of medical sciences,Tabriz, Iran. In this study 200 patients who are selected based on inclusion and exclusion criteria will be divided into two groups (100 in each group) by block randomization.Patients in control group will be prescribed standard regimen for COVID-19. Patients in Metformin group will be prescribed Metformin 500 mg BID for two weeks and standard regimen for COVID-19. The routine lab data, need for hospitalization and mortality rate will be assessed in both groups.
Participants/Inclusion and exclusion criteria
All patients with Covid-19 symptoms in patients with the history of close contact with suspected people in the last 14 days fever pulmonary involvement normal or reduced cbc reduced lymphocyte, positive PCR
exclusion criteria: patients with type I diabetes
Ketoacidosis
decompensated heart failure
severe kidney failure (GFR<30 ml/min)
metabolic acidosis
severe respiratory failure
immediate need for intubation
Intervention groups
control group: received standard regimen for COVID-19
metformin group: received standard regimen for COVID-19 plus metformin 500 BID
Main outcome variables
decrease need to hospitalization; decrease ARDS symptoms; decrease mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160310026998N10
Registration date:2020-03-26, 1399/01/07
Registration timing:registered_while_recruiting
Last update:2020-03-26, 1399/01/07
Update count:0
Registration date
2020-03-26, 1399/01/07
Registrant information
Name
Saba Ghaffary
Name of organization / entity
Faculty of Pharmacy, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33266042
Email address
ghaffarys@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the metformin effect on the survival and recovery rate of COVID-19 patients
Public title
Study of the metformin effect on the survival and recovery rate of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Covid-19 symptoms in patients with the history of close contact with suspected people in the last 14 days
fever
pulmonary involvement
normal or reduced cbc
reduced lymphocyte
positive PCR
Exclusion criteria:
patients with type I diabetes
Ketoacidosis
decompensated heart failure
severe rebal failure (GFR<30 ml/min)
metabolic acidosis
immediate need for intubation
severe respiratory failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with computer generated digits
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 at Tabriz University of Medical Sciences
Street address
Faculty pf pharmacy, Tabriz University of Medical Sciences, Shahid ghazi hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.TBZMED.REC.1398.1309
Health conditions studied
1
Description of health condition studied
corona virus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
decreased need to hospitalization
Timepoint
2 weeks
Method of measurement
obsevation
2
Description
decreased mortality
Timepoint
2 weeks
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in addition to standard regimen of covid-19 patients will be administered Metformin 500 mg BID orally for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: standard regimen of covid-19 patients
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykhoraeis clinic
Full name of responsible person
saba ghaffary
Street address
sheikhoraeis clinic, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
51665158
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Street address
Central building of Tabriz University of Medical Sciences, Golgasht boulevard, Azadi street
City
tabriz
Province
East Azarbaijan
Postal code
51665158
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Pharmacotherapy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, I
City
Tabriz
Province
East Azarbaijan
Postal code
14766 - 51664
Phone
+98 33266042
Fax
Email
ghaffarys@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Pharmacotherapy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, I
City
Tabriz
Province
East Azarbaijan
Postal code
14766 - 51664
Phone
+98 33266042
Fax
Email
ghaffarys@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Pharmacotherapy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, I
City
Tabriz
Province
East Azarbaijan
Postal code
14766 - 51664
Phone
+98 33266042
Fax
Email
ghaffarys@tbzmed.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
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