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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Placebo controlled trial

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Telmisartan 		Telmisartan 40 mg po daily x 21 days
  • Drug: Telmisartan 40mg
    Angiotensin Receptor Blocker (ARB)
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Placebo once daily

Recruiting Locations

More Details

NCT ID
NCT04360551
Status
Terminated
Sponsor
University of Hawaii

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.