Combination of Spironolactone and Sitagliptin Improves Clinical Outcomes
of Outpatients with COVID-19: A Prospective Cohort Study
Abstract
Rationale: Coronavirus disease 2019 (COVID-19) leads to
hospitalization and death, especially in elderly and those with
comorbidities. There are evidences showing that sitagliptin and
spironolactone can potentially improve the clinical outcomes of COVID-19
cases. Objective: In this observational study on acutely
symptomatic outpatient COVID-19 cases, we investigated the effects of
spironolactone and sitagliptin on the outcomes of the disease.
Methods: This prospective cohort study was conducted at Shiraz
University of Medical Sciences Clinics during the fifth wave of the
COVID-19 pandemic between July 2021 and September 2021. We followed mild
to moderate symptomatic COVID-19 patients, who were treated with either
combination (spironolactone 100 mg daily and sitagliptin 100 mg daily)
or standard (steroid, antiviral and/or supportive care) therapy up to 30
days. Our primary outcome was hospitalization rate. The secondary
outcomes included ER visit, duration of disease, and complications, such
as hypoglycemia, low blood pressure or altered mental status.
Results: Of the 206 patients referred to clinics, 103 received
standard therapy and 103 treated with combination therapy. There were no
significant differences in baseline characteristics, except for slightly
higher clinical score in control group (6.92 ± 4.01 control, 4.87 ± 2.92
combination; P <0.0001). Treatment with combination
therapy was associated with lower admission rate (5.8% combination,
22.3% control; P = 0.0011), ER visits (7.8% combination, 23.3%
control; P = 0.0021) and average duration of symptoms (6.67 ±
2.30 days combination, 18.71 ± 6.49 days control; P
=<0.0001). Conclusion: In this prospective cohort
study of acutely ill outpatients with COVID-19, the combination of
sitagliptin and spironolactone reduced duration of COVID infection and
hospital visits better than standard therapeutic approaches. The effects
of combination of sitagliptin and spironolactone in COVID-19 patients
should be further verified in a double blind, randomized,
placebo-controlled trial. Iranian Registry of Clinical Trials:
IRCT registration number: IRCT20201003048904N2, Registration date:
December 10, 2020.