Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

University of Hawaii

Status and phase

Terminated

Phase 2

Conditions

COVID-19

Treatments

Drug: Placebo

Drug: Telmisartan 40mg

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04360551

U54MD007601-34S3 (U.S. NIH Grant/Contract)

H051

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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