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Evaluation the efficacy and safety of Sitagliptin administration in patients with COVID-19

Protocol summary

Study aim
Evaluation the efficacy and safety of Sitagliptin administration in patients with COVID-19
Design
Randomized clinical trial with control group, Clinical Trial 3, Sample size: 84
Settings and conduct
This study will be performed as a randomized clinical trial with a control group and sample size of 84 in Dr. Masih Daneshvari Hospital. In this study, patients in Sitagliptin group receive Sitagliptin (Dr.Abidi Pharmaceuticals, Iran) at dose of 50 mg BID twice a day for totally 10 days and the control group will not take this medicine. The other standard and supportive treatment will be done (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID Hydroxychloroquine sulfate 400 mg one dose) for both groups similarly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Laboratory confirmed COVID-19 with RT-PCR, Age over 18 years old, Oxygen saturation < 93%, Fever more than 72 hours before admission, Bilateral pulmonary infiltration Exclusion criteria: Chronic kidney Disease, Acute kidney Injury, Pregnancy or breastfeeding, Drug allergy, history Chronic liver disease, Mild phase of COVID-19 Critical phase of COVID-19 and Pancreatitis
Intervention groups
In this study, patients in Sitagliptin group receive Sitagliptin (Dr.Abidi Pharmaceuticals, Iran) at dose of 50 mg BID twice a day for totally 10 days and the control group will not take this medicine. The other standard and supportive treatment will be done (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID Hydroxychloroquine sulfate 400 mg one dose) for both groups similarly.
Main outcome variables
Fever, cough, and shortness of breath

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200420047147N1
Registration date: 2020-04-23, 1399/02/04
Registration timing: prospective

Last update: 2020-04-23, 1399/02/04
Update count: 0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Ahad Zare
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University,Tehr
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 0888
Email address
ahadzareee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy and safety of Sitagliptin administration in patients with COVID-19
Public title
ٍEvaluation the effects of Sitagliptin administration in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who diagnosed with COVID-19 by RT-PCR test Oxygen saturation less than 93% Age more than 18 years old To sign the informed consent form
Exclusion criteria:
Chronic kidney disease Acute kidney injury Chronic liver disease pregnancy or breastfeeding Pancreatitis Allergy to Sitagliptin Pemphigus disease history
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study. 21 blocks including 4 patients generated with online website (www.randomizer.org). In each block, two patients will be assigned to Sitagliptin group and two patients will be assigned to Control group by random order.
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
National Research Institute of Tuberculosis and Lung Diseases - Shahid Beheshti University of Medica
Street address
Darabad Avenue, Shahid Bahonar roundabout, Niavaran, Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-04-07, 1399/01/19
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.029

Health conditions studied

1

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

Primary outcomes

1

Description
Fever
Timepoint
Daily, From admission to discharge time
Method of measurement
Thermometer

2

Description
Cough
Timepoint
Daily, From admission to discharge time
Method of measurement
Observation

3

Description
Dyspnea
Timepoint
Daily, From admission to discharge time
Method of measurement
Observation

Secondary outcomes

1

Description
Hospitalization duration
Timepoint
At admission time and discharge time
Method of measurement
Clinical records

2

Description
Lung radiology changes
Timepoint
At admission time and 14 days later
Method of measurement
Computed tomography

3

Description
Adverse Drug Reaction
Timepoint
Daily, From admission to discharge time
Method of measurement
Observation

4

Description
Virological clearance
Timepoint
At admission time and 14 days later
Method of measurement
Reverse transcription polymerase chain reaction

5

Description
Needs to mechanical ventilation
Timepoint
Daily,From admission to discharge time
Method of measurement
Medical Record

6

Description
Death
Timepoint
At end of the study
Method of measurement
Medical Record

Intervention groups

1

Description
Intervention group: Patients in Sitagliptin group receive Sitagliptin (Dr.Abidi Pharmaceuticals, Iran) at dose of 50 mg BID twice a day for totally 10 days and the other standard and supportive treatment (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID and Hydroxychloroquine sulfate 400 mg one dose) will be administered.
Category
Treatment - Drugs

2

Description
Standard and supportive treatment (including Lopinavir and ritonavir at dose of 200/50 mg two tablets BID and Hydroxychloroquine sulfate 400 mg one dose) will be administered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Masih Daneshvari Hospital
Full name of responsible person
Dr. Atefe Abedini
Street address
Masih Daneshvari Hospital, Darabad Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
dr.abedini110@gmail.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
80
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

2

Sponsor
Name of organization / entity
Sarem Cell Research Center (SCRC), Sarem Women's Hospital, Tehran, Iran
Full name of responsible person
Ahad Zare
Street address
Sarem Hospital, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396956111
Phone
+98 21 4467 0888
Email
ahadzareee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sarem Cell Research Center (SCRC), Sarem Women's Hospital, Tehran, Iran
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Masih Daneshvari Hospital, Darabad Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fzh.dastan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sarem Cell Research Center(SCRC), Sarem Women's Hospital.
Full name of responsible person
Ahad Zare
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Sarem Women's Hospital, Ekbatan Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
139656111
Phone
+98 21 4467 0888
Email
ahadzareee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Abedini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Interventional Pulmonology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Fax
Email
dr.abedini110@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
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. Ahad Zare/ Sarem Women's Hospital,Ekbatan Town, Tehran, Iran Dr. Farzaneh Dastan, Dr.Atefeh Abedini/ Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran.
What processes are involved for a request to access data/document
Official letter to the researchers
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