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IRCT20201003048904N2 IRCT 2020-12-10 Boushehr University of Medical Sciences combination therapy trial in COVID-19 patients : Evaluation of the effect of spironolactone and DDP4 inhibitors on treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19) 2020-12-05 anticipated 200 Complete https://irct.ir/trial/52607 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, 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 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. N/A COVID19. Intervention 1: Intervention group 1: will receive sitagliptin 100 mg daily for 5days in addition to standard treatment of COVID19. Intervention 2: Intervention group 2: will receive spironolactone 100 mg daily for 5 days in addition to standard treatment of COVID19. Intervention 3: Intervention group 3: will receive spironolactone 100 mg daily and sitagliptin 100 mg for 5 days in addition to standard treatment of COVID19. Intervention 4: Control group: will receive only standard treatment of COVID19. Intervention 5: Intervention group: OPD prescription of combination of spironolactone 100 mg daily and Januvia 100 mg daily in addition to standard treatment of COVID19. Intervention 6: Control group: OPD prescription of standard treatment for COVID-19. Yes - There is a plan to make this available What will be shared: The main variables and outcomes studied will be published: Percentage of blood oxygen saturation, CT scan, and demographic variables When: 12 months after publishing the results To whom: faculty members Conditions: To integrate data with other studies Where to obtain: Dr Farhad Abbasi: f_abbasi55@yahoo.com How to obtain: The objectives and scope of the draft research plan are reviewed and approved if they are consistent with the data. Comments:
public Farhad Abbasi
No.15, Erfan 16 alley, Motahari St
Bushehr Iran (Islamic Republic of) 7516654933 +98 77 3358 0309 f_abbasi55@yahoo.com Boushehr University of Medical Sciences scientific Farhad Abbasi
No.15, Erfan 16 alley, Motahari St., Bushehr, Iran
Bushehr Iran (Islamic Republic of) 7516654933 +98 77 3358 0309 f_abbasi55@yahoo.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 20 years no limit Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: will receive sitagliptin 100 mg daily for 5days in addition to standard treatment of COVID19 Intervention group 2: will receive spironolactone 100 mg daily for 5 days in addition to standard treatment of COVID19 Intervention group 3: will receive spironolactone 100 mg daily and sitagliptin 100 mg for 5 days in addition to standard treatment of COVID19 Control group: will receive only 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 Control group: OPD prescription of standard treatment for COVID-19 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. 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. Boushehr University of Medical Sciences Approved 2020-11-18 Ethics committee of Bushehr university of medical sciences Salman_farsi Blvd Bushehr Boushehr Iran (Islamic Republic of)