NCT04715763

INvestigating TELmisartin Study

Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Hawaii · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Telmisartan Oral Product	Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
DRUG	Placebo	Gelatin capsules filled with an inactive ingredient

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2021-01-20
• Last updated: 2022-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study