: Evaluation of the effect of spironolactone and DDP4 inhibitors on treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19)

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.

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.

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.

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

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.

blood Oxygen saturation percentage Lung HRCT findings

To add OPD patients to our intervention in an intervention group and a control group.

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.

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.

The main variables and outcomes studied will be published: Percentage of blood oxygen saturation, CT scan, and demographic variables

12 months after publishing the results

faculty members

To integrate data with other studies

Dr Farhad Abbasi: f_abbasi55@yahoo.com

The objectives and scope of the draft research plan are reviewed and approved if they are consistent with the data.