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.
Drug: Telmisartan Oral Product
Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
Other Name: Micardis
Drug: Placebo
Gelatin capsules filled with an inactive ingredient
Inclusion Criteria:
- Able to provide written informed consent prior to initiation of any study procedures.
- Within 72 hours of initial hospitalization for acute COVID-19 disease management
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Able to easily swallow pills
Exclusion Criteria:
- Systolic blood pressure less than 100 mmHg
- Self-reported history of decompensated liver failure
- Pregnancy or breast feeding
- Allergy to the study medication
- Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors
(ARNIs). Blood pressure medications in other classes will be permitted as long as the
systolic BP is >100 mmHg
- Currently receiving vasopressors for hypotension
- Prior reaction or intolerance to ARB, ACE Inhibitor or ANRI for whom study
participation would not be advisable in the opinion of the study team
- Current use of and on-going need for aliskiren, lithium, digoxin, and potassium
sparing diuretics such as spironolactone
- Participating in other drug clinical trials EXCEPT for other COVID-19 treatment trials
which will be allowed with the permission of the Corresponding PI or Co-PI and
concurrence of the treating physician/hospitalist
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10x upper limit
of normal (ULN) within 24 hours of baseline
- Absolute neutrophil count (ANC) < 1000/mL within 24 hours of baseline
- Platelet count < 50,000/mL within 24 hours of baseline.
- Patients with acute kidney injury (AKI) or chronic kidney disease (CKD) including
individuals on hemodialysis may be enrolled based on the investigator's clinical
judgement.
- Any serious medical condition/ abnormality or other issues that, in the investigator's
judgment, precludes the patient's safe participation in and completion of the study or
suggests that the study is not in the patient's best interest
- In the opinion of the investigator, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatments
Queen's Medical Center
Honolulu, Hawaii, United States
Cecilia M Shikuma, Principal Investigator
University of Hawaii at Manoa John A Burns School of Medicine