: Evaluation of the effect of spironolactone and DDP4 inhibitors on treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19)
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General information
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To add OPD patients to our intervention in an intervention group and a control group.
To add OPD patients to our intervention in an intervention group and a control group.
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اضافه کردن بیماران سرپایی به طرح در قالب یک گروه مداخله و یک گروه کنترل.
اضافه کردن بیماران سرپایی به طرح در قالب یک گروه مداخله و یک گروه کنترل.
admitted patients in Bushehr's Shohadaye_Khalije_Fars hospital due to COVID19 diagnosis confirmed by Rt-PCR
age equal or more than 20
admitted patients in Bushehr's Shohadaye_Khalije_Fars hospital due to COVID19 diagnosis confirmed by Rt-PCR
age equal or more than 20
Male and female OPD patients with confirmed or probable SARS-CoV-2 infection according to WHO and CDC definitions referred to Motahari Clinic.
admitted patients in Bushehr's Shohadaye_Khalije_Fars hospital due to COVID19 diagnosis confirmed by Rt-PCR age equal or more than 20 Male and female OPD patients with confirmed or probable SARS-CoV-2 infection according to WHO and CDC definitions referred to Motahari Clinic.
بیماران بستری در بیمارستان شهدای خلیج فارس بوشهر با تشخیص قطعی کووید 19 با تست PCR
سن مساوی یا بالای 20 سال
بیماران بستری در بیمارستان شهدای خلیج فارس بوشهر با تشخیص قطعی کووید 19 با تست PCR
سن مساوی یا بالای 20 سال
بیماران مبتلا به کووید 19 سرپایی مراجعه کننده به کلینیک مطهری.
بیماران بستری در بیمارستان شهدای خلیج فارس بوشهر با تشخیص قطعی کووید 19 با تست PCR سن مساوی یا بالای 20 سال بیماران مبتلا به کووید 19 سرپایی مراجعه کننده به کلینیک مطهری.
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Intervention in outpatients and inpatients will be done separately. In outpatients, a control group will receive standard Covid treatment. And the other group who go to another clinic will receive dual drug treatment in addition to the standard Covid treatment. The intervention in hospitalized patients is designed as four arms, which has been described before.
Intervention in outpatients and inpatients will be done separately. In outpatients, a control group will receive standard Covid treatment. And the other group who go to another clinic will receive dual drug treatment in addition to the standard Covid treatment. The intervention in hospitalized patients is designed as four arms, which has been described before.
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مداخله در بیماران سرپایی و بستری به صورت جداگانه صورت خواهد گرفت. در بیماران سرپایی یک گروه کنترل درمان استاندارد کووید را دریافت خواهد کرد. و گروهی دیگر که به کلینیک دیگری مراجعه کرده اند علاوه بر درمان استاندارد کووید، درمان دو دارویی را دریافت خواهند کرد. مداخله در بیماران بستری به صورت چهار بازویی طراحی شده است که پیش از این توضیح داده شده است.
مداخله در بیماران سرپایی و بستری به صورت جداگانه صورت خواهد گرفت. در بیماران سرپایی یک گروه کنترل درمان استاندارد کووید را دریافت خواهد کرد. و گروهی دیگر که به کلینیک دیگری مراجعه کرده اند علاوه بر درمان استاندارد کووید، درمان دو دارویی را دریافت خواهند کرد. مداخله در بیماران بستری به صورت چهار بازویی طراحی شده است که پیش از این توضیح داده شده است.
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.
Inpatient: 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.
Outpatient: the intervention is performed in two separate clinics. One clinic prescribes only standard Covid treatment and one clinic provides dual drug treatment in addition to standard treatment.
Inpatient: 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. Outpatient: the intervention is performed in two separate clinics. One clinic prescribes only standard Covid treatment and one clinic provides dual drug treatment in addition to standard treatment.
تصادفی سازی به روش تقسیم تصادفی بلوکی یا Blocked Randomization انجام خواهد شد. به طوری که چهار گروه D و B و S و C به عنوان گروه های مداخله و کنترل در نظر گرفته می شود. 24 بلوک از ترکیب حروف فوق بوجود می آید. با توجه به اینکه در هر گروه 50 بیمار قرار می گیرد، مجموعا 200 نمونه مورد نیاز است بنابراین از بلوک های فوق 9 بلوک به صورت تصادفی ( قرار دادن هر 24 نوع بلوک در یک ظرف و انتخاب آن به صورت تصادفی و با جایگذاری) انتخاب می شود و آن ها را به صورت زنجیره وار پشت هم نوشته می شود. بیماران گروه D در نهایت مهارکننده DPP4، گروه S اسپیرنولاکتون و گروه B هردو دارو را دریافت می کنند و بیماران گروه C گروه کنترل خواهند بود. فرد مراجعه کننده از قبل مشخص می شود در کدام گروه قرار خواهد گرفت.
در بیماران بستری تصادفی سازی به روش تقسیم تصادفی بلوکی یا Blocked Randomization انجام خواهد شد. به طوری که چهار گروه D و B و S و C به عنوان گروه های مداخله و کنترل در نظر گرفته می شود. 24 بلوک از ترکیب حروف فوق بوجود می آید. با توجه به اینکه در هر گروه 50 بیمار قرار می گیرد، مجموعا 200 نمونه مورد نیاز است بنابراین از بلوک های فوق 9 بلوک به صورت تصادفی ( قرار دادن هر 24 نوع بلوک در یک ظرف و انتخاب آن به صورت تصادفی و با جایگذاری) انتخاب می شود و آن ها را به صورت زنجیره وار پشت هم نوشته می شود. بیماران گروه D در نهایت مهارکننده DPP4، گروه S اسپیرنولاکتون و گروه B هردو دارو را دریافت می کنند و بیماران گروه C گروه کنترل خواهند بود. فرد مراجعه کننده از قبل مشخص می شود در کدام گروه قرار خواهد گرفت.
در بیماران سرپایی مداخله در دو درمانگاه جداگانه صورت میگیرد. یک درمانگاه فقط درمان استاندارد کووید تجویز می شود و یک درمانگاه علاوه بر درمان استاندارد، درمان دو دارویی صورت میگیرد.
در بیماران بستری تصادفی سازی به روش تقسیم تصادفی بلوکی یا Blocked Randomization انجام خواهد شد. به طوری که چهار گروه D و B و S و C به عنوان گروه های مداخله و کنترل در نظر گرفته می شود. 24 بلوک از ترکیب حروف فوق بوجود می آید. با توجه به اینکه در هر گروه 50 بیمار قرار می گیرد، مجموعا 200 نمونه مورد نیاز است بنابراین از بلوک های فوق 9 بلوک به صورت تصادفی ( قرار دادن هر 24 نوع بلوک در یک ظرف و انتخاب آن به صورت تصادفی و با جایگذاری) انتخاب می شود و آن ها را به صورت زنجیره وار پشت هم نوشته می شود. بیماران گروه D در نهایت مهارکننده DPP4، گروه S اسپیرنولاکتون و گروه B هردو دارو را دریافت می کنند و بیماران گروه C گروه کنترل خواهند بود. فرد مراجعه کننده از قبل مشخص می شود در کدام گروه قرار خواهد گرفت. در بیماران سرپایی مداخله در دو درمانگاه جداگانه صورت میگیرد. یک درمانگاه فقط درمان استاندارد کووید تجویز می شود و یک درمانگاه علاوه بر درمان استاندارد، درمان دو دارویی صورت میگیرد.
Intervention groups
#1
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Treatment - Drugs
treatment-drugs
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Intervention group: OPD prescription of combination of spironolactone 100 mg daily and Januvia 100 mg daily in addition to standard treatment of COVID19
Intervention group: OPD prescription of combination of spironolactone 100 mg daily and Januvia 100 mg daily in addition to standard treatment of COVID19
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گروه مداخله: درمان استاندارد کووید 19 را به علاوه اسپیرنولاکتون 100 میلی گرم روزانه و سیتاگلیپتین 100 میلی گرم روزانه 5 روز دریافت می کنند
گروه مداخله: درمان استاندارد کووید 19 را به علاوه اسپیرنولاکتون 100 میلی گرم روزانه و سیتاگلیپتین 100 میلی گرم روزانه 5 روز دریافت می کنند
#2
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Treatment - Drugs
treatment-drugs
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Control group: OPD prescription of standard treatment for COVID-19
Control group: OPD prescription of standard treatment for COVID-19
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گروه کنترل: فقط درمان استاندارد کووید 19 را به صورت سرپایی دریافت می کنند
گروه کنترل: فقط درمان استاندارد کووید 19 را به صورت سرپایی دریافت می کنند
Recruitment centers
#1
Name of recruitment center - English: Motahari clinic
Name of recruitment center - Persian: درمانگاه مطهری
Full name of responsible person - English: Mohammad Ali Davarpanah
Full name of responsible person - Persian: محمدعلی داورپناه
Street address - English: Karim Khan Zand Boulevard
Street address - Persian: بلوار کریم خان زند
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814734
Phone: +98 71 3612 1000
Fax:
Email: davarpanah1349@gmail.com
Web page address:
Name of recruitment center - English: Motahari clinic Name of recruitment center - Persian: درمانگاه مطهری Full name of responsible person - English: Mohammad Ali Davarpanah Full name of responsible person - Persian: محمدعلی داورپناه Street address - English: Karim Khan Zand Boulevard Street address - Persian: بلوار کریم خان زند City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134814734 Phone: +98 71 3612 1000 Fax: Email: davarpanah1349@gmail.com Web page address:
#2
Name of recruitment center - English: Motahari clinic
Name of recruitment center - Persian: درمانگاه مطهری
Full name of responsible person - English: Hossain Faramarzi
Full name of responsible person - Persian: حسین فرامرزی
Street address - English: Karim Khan Zand Boulevard
Street address - Persian: بلوار کریم خان زند
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814734
Phone: +98 71 3612 1000
Fax:
Email: Hossainfaramarzi@yahoo.com
Web page address:
Name of recruitment center - English: Motahari clinic Name of recruitment center - Persian: درمانگاه مطهری Full name of responsible person - English: Hossain Faramarzi Full name of responsible person - Persian: حسین فرامرزی Street address - English: Karim Khan Zand Boulevard Street address - Persian: بلوار کریم خان زند City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134814734 Phone: +98 71 3612 1000 Fax: Email: Hossainfaramarzi@yahoo.com Web page address:
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.
To add OPD patients to our intervention in an intervention group and a control group.
Acronym
IRCT registration information
IRCT registration number:IRCT20201003048904N2
Registration date:2020-12-10, 1399/09/20
Registration timing:registered_while_recruiting
Last update:2022-02-07, 1400/11/18
Update count:1
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
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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
Male and female OPD patients with confirmed or probable SARS-CoV-2 infection according to WHO and CDC definitions referred to Motahari Clinic.
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
Inpatient: 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.
Outpatient: the intervention is performed in two separate clinics. One clinic prescribes only standard Covid treatment and one clinic provides dual drug treatment in addition to standard treatment.
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
Intervention in outpatients and inpatients will be done separately. In outpatients, a control group will receive standard Covid treatment. And the other group who go to another clinic will receive dual drug treatment in addition to the standard Covid treatment. The intervention in hospitalized patients is designed as four arms, which has been described before.
Secondary Ids
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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
5
Description
Intervention group: OPD prescription of combination of spironolactone 100 mg daily and Januvia 100 mg daily in addition to standard treatment of COVID19
Category
Treatment - Drugs
6
Description
Control group: OPD prescription of standard treatment for COVID-19
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
2
Recruitment center
Name of recruitment center
Motahari clinic
Full name of responsible person
Mohammad Ali Davarpanah
Street address
Karim Khan Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3612 1000
Email
davarpanah1349@gmail.com
3
Recruitment center
Name of recruitment center
Motahari clinic
Full name of responsible person
Hossain Faramarzi
Street address
Karim Khan Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3612 1000
Email
Hossainfaramarzi@yahoo.com
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?