This study will enroll 40 symptomatic outpatients tested positive for Coronavirus 2019 (COVID-19). Patients to be randomized 1:1 to Telmisartan (40 mg) vs placebo to be administered orally once daily x 21 days. Daily, the study patients will be asked to keep a record of the severity of their fever, dyspnea and fatigue and take their blood pressure (BP) and temperature. Study visits to occur on day 1 (entry), day 4, day 10 and day 21. Oro-pharyngeal swabs, and approximately 25 cc of blood will be collected at each study visit for safety labs and for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of inflammation, coagulation and fibrosis.
Drug: Telmisartan 40mg
Angiotensin Receptor Blocker (ARB)
Drug: Placebo
Placebo once daily
Inclusion Criteria:
- Able to provide written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures including self testing
of blood pressure daily
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (SARS-CoV-2)
infection as determined by FDA-approved commercial or public health assay in any
specimen collected ideally < 72 hours prior to randomization. Exceptions to the <72 hr
inclusion criteria may be made at the discretion of the investigator.
- Positive for COVID-19 symptoms: fever defined as a temperature of >100.4 on study
screening or self-report of daily fever at home OR shortness of breath of any degree
OR fatigue causing greater than minimal interference with usual social & functional
activities
- Women of childbearing potential must agree to use at least one primary form of
contraception for the duration of the study
- Able to easily swallow pills
Exclusion Criteria:
- Immediate need for hospitalization on screening
- Systolic blood pressure less than 100 mmHg
- Self-reported presence of chronic kidney disease or requiring dialysis
- Self-reported history of liver failure or untreated hepatitis B or C
- Pregnancy or breast feeding
- Allergy to the study medication
- Current use of angiotensin receptor blocker (ARB) or angiotensin converting enzyme
(ACE) Inhibitor medications. Other blood pressure medications will be permitted in the
systolic BP is higher than 90 mmHg
- Prior reaction or intolerance to ARB or ACE Inhibitor
- Use of aliskiren in patients with diabetes
- Current use of and on-going need for lithium, digoxin, potassium sparing diuretics
such as spironolactone
- Current use of and need for potassium supplements
- Current or past participation in a research study within 12 weeks prior to the
Screening Visit unless cleared by Study Team
- Inability to drive safely for study visits
- Subjects, who, in the opinion of the investigator, are unable to comply with the
protocol evaluation, or for whom study participation may not be advisable
University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
Honolulu, Hawaii, United States
Cecilia M Shikuma, MD, Principal Investigator
University of Hawaii at Manoa John A Burns School of Medicine