This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.
The study is intended to assess, in a pilot study, the effect of telmisartan in mitigating the severity of COVID-19 related disease in hospitalized patients. Data on clinical course and lab values will be passively abstracted from Queen's standard of care evaluations on COVID-19 in-patients. Participants will be monitored closely as an outpatient if/when discharged prior to day 21. The only study-specific procedure will be a blood draw of ten (10) cc to be collected for research purposes at entry and at day 4 and day 21 of study for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
Gelatin capsules filled with an inactive ingredient
Queen's Medical Center
Honolulu, Hawaii, United States
Duration of hospitalization
Number of days of patient's hospitalization
Time frame: Over the 21 day period of study
Duration of supplemental oxygen
Median number of days patients required supplemental oxygen in each arm
Time frame: over the 21 days of study
Duration of mechanical ventilation
Median number of days patients required mechanical ventilation in each arm
Time frame: over the 21 days of study
Number of deaths
Total number of deaths during the study period in each arm
Time frame: over the 21 days of study
Number of grade 3 and greater adverse events
Total number of Grade 3 and greater adverse events that occurred in each arm
Time frame: over the 21 days of study
Clinical severity of disease
Clinical severity of disease as assessed by WHO Clinical Status ordinal scale (scores range from minimum value of 1 (not hospitalized, no limitations on activities) to maximum value of 7 (death); higher is worse outcome.
Time frame: On day 4 and day 21 of study
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