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

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hawaii
• Treatments: Telmisartan

Criteria

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