Protocol summary

Study aim
Study of the effectiveness of concomitant use of vitamin C, metformin, azithromycin and doxycycline on improving patients with COVID-19
Design
This study is a non-blinded clinical trial. The study population will include all patients with coronavirus referring to Golestan hospital of Kermanshah. 40 eligible patients will be selected conveniently and randomly assigned to two intervention and control groups.
Settings and conduct
This study that will be conducted in the Golestan hospital of Kermanshah is a non-blinded one. At the beginning of the study, clinical information is recorded in a checklist daily and imaging findings of a patient with suspected pneumonia are recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with coronavirus have mild to moderate viral infections diagnosed by an infectious disease specialist Exclusion criteria: Patients with severe lung involvement and severe respiratory symptoms; patients with G6PD deficiency
Intervention groups
The intervention group will receive 250 mg of azithromycin daily, 100 mg of doxycycline twice daily, 1.5 g of vitamin C every 6 hours, and 500 mg of metformin daily for one week.
Main outcome variables
Disease recovery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200418047121N1
Registration date: 2020-05-01, 1399/02/12
Registration timing: prospective

Last update: 2020-05-01, 1399/02/12
Update count: 0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
KAMRAN MANSOURI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6473
Email address
kmansouri@kums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
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 the effectiveness of concomitant use of vitamin C, metformin, azithromycin and doxycycline on improving patients with COVID-19
Public title
Study the effectiveness of concomitant use of vitamin C, metformin, azithromycin and doxycycline on improving patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with coronavirus have mild to moderate viral infections diagnosed by an infectious disease specialist
Exclusion criteria:
Patients with severe lung involvement and severe respiratory symptoms patients with G6PD deficiency
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 20. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the 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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
ir.kums.rec.1399.079

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Disease recovery
Timepoint
The beginning of the study and the end of the study
Method of measurement
Based on laboratory and imaging criteria

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive 250 mg of azithromycin daily for up to five days, 100 mg of doxycycline twice daily, 1.5 g of vitamin C every 6 hours, and 500 mg of metformin daily for one week.
Category
Treatment - Drugs

2

Description
The control group will receive the usual medication.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Faizullah Mansouri
Street address
Golestan Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
F_mansoury@ yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Medical Biology Research Center, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
kamranmansouri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Faizullah Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Emam Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
F_mansoury@ yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Medical Biology Research Center, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
kamranmansouri@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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe
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