Protocol summary

Study aim
Determining the effect of DPP4 and spironolactone inhibitors in the treatment of COVID-19 Determining the effect of DPP4 inhibitors and spironolactone on blood oxygen saturation and Lung HRCT findings in COVID19 patients.
Design
The study will be a 4arms clinical trial with parallel groups.The three intervention groups will receive Sitagliptin , Spironolactone, and a combination of both drugs, respectively, and all intervention and control groups will receive COVID 19 standard treatment. Each group will have 50 patients whom are allocated to the groups using block randomization method.
Settings and conduct
This study will be performed in Bushehr's Shohadaye Khalije Fars Hospital. After reviewing the patient's history, examinations and paraclinical findings, the researcher will enter patients into the study and then the patients admitted to the study will be randomly allocate to each study groups. General condition, respiratory status, SPO2, CT scan report and patient paraclinical information at first, third and fifth day of the study will be included in the checklist.
Participants/Inclusion and exclusion criteria
inclusion: admitted patients in Bushehr's SKF hospital due to PCR positive COVID19 >= 20 years old exclusion: pregnancy spironolactone or DPP4 inhibitor consumption drug contraindications intubation and mechanical ventilation at admission onset
Intervention groups
All patients will receive standard treatment of Covid 19 based on the Ministry of Health guidelines (dexamethasone, antiviral treatment, antibiotic treatment, anticoagulant, supplement, etc.). In addition, the first and second intervention groups will receive 100 mg of sitagliptin and Spironolactone daily, respectively for 5 days, and the third intervention group receives both of these drugs in combination for 5 days.
Main outcome variables
blood Oxygen saturation percentage Lung HRCT findings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201003048904N2
Registration date: 2020-12-10, 1399/09/20
Registration timing: registered_while_recruiting

Last update: 2020-12-10, 1399/09/20
Update count: 0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Farhad Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3355 8990
Email address
fa.abbasi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Evaluation of the effect of spironolactone and DDP4 inhibitors on treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19)
Public title
combination therapy trial in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
admitted patients in Bushehr's Shohadaye_Khalije_Fars hospital due to COVID19 diagnosis confirmed by Rt-PCR age equal or more than 20
Exclusion criteria:
pregnancy positive history of spironolactone or DPP4 inhibitor consumption contraindications for drug intervention consumption (Plasma Acid/base, Electrolyte or Glucose abnormalities) hypersensitivity to drugs patient dissatisfaction intubation and mechanical ventilation at admission onset
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by Blocked Randomization method. four groups D, B, S and C are considered as intervention and control groups. 24 blocks are formed from the combination of the letters above. Considering that there are 50 patients in each group, a total of 200 samples are needed, so 9 of the above blocks are randomly selected (placing all 24 types of blocks in a container and selecting it randomly and by placement) will be written in a chain. Patients in group D will eventually receive DPP4 inhibitors, group S will receive spironolactone, group B will receive both drugs, and patients in group C will be in control group, and the client will be identified in advance.
Blinding (investigator's opinion)
Double blinded
Blinding description
After receiving an explanation about how to implement the plan and the nature of the drugs received, as well as the possible benefits and side effects, the patient will not know which group he is in. Also, the details of which group the results belong to will not be provided to the statistical analyzer.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Bushehr university of medical sciences
Street address
Salman_farsi Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.BPUMS.REC.1399.140

Health conditions studied

1

Description of health condition studied
COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
The blood oxygen saturation percentage is examined as an index of oxygenation status.
Timepoint
first, third and fifth day of study
Method of measurement
pulsoxymeter

Secondary outcomes

1

Description
Lung involvement description and percentage in lung HRCT scan.
Timepoint
first and fifth day of study
Method of measurement
Lung HRCT scan which will be reported by a radiologist

Intervention groups

1

Description
Intervention group 1: will receive sitagliptin 100 mg daily for 5days in addition to standard treatment of COVID19
Category
Treatment - Drugs

2

Description
Intervention group 2: will receive spironolactone 100 mg daily for 5 days in addition to standard treatment of COVID19
Category
Treatment - Drugs

3

Description
Intervention group 3: will receive spironolactone 100 mg daily and sitagliptin 100 mg for 5 days in addition to standard treatment of COVID19
Category
Treatment - Drugs

4

Description
Control group: will receive only standard treatment of COVID19
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr's Shohadaye Khalije Fars Hospital
Full name of responsible person
Farhad Abbasi
Street address
Taleghani Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 5375
Email
mpgh@bpums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Salman_farsi Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0178
Email
Research@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Farhad Abbasi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No.15, Erfan 16 alley, Motahari St
City
Bushehr
Province
Boushehr
Postal code
7516654933
Phone
+98 77 3358 0309
Email
f_abbasi55@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Farhad Abbasi
Position
Assistant Profssor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
No.15, Erfan 16 alley, Motahari St., Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
7516654933
Phone
+98 77 3358 0309
Email
f_abbasi55@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Farzan Azodi
Position
MD, Non-faculty member
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 12, Shahid Feshangsaz Ave, Emam khomeyni Blvd
City
Bushehr
Province
Boushehr
Postal code
7514767796
Phone
+98 77 3332 8598
Email
azodi.farzan@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main variables and outcomes studied will be published: Percentage of blood oxygen saturation, CT scan, and demographic variables
When the data will become available and for how long
12 months after publishing the results
To whom data/document is available
faculty members
Under which criteria data/document could be used
To integrate data with other studies
From where data/document is obtainable
Dr Farhad Abbasi: f_abbasi55@yahoo.com
What processes are involved for a request to access data/document
The objectives and scope of the draft research plan are reviewed and approved if they are consistent with the data.
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