Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
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
- COVID-19
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Telmisartan |
Telmisartan 40 mg po daily x 21 days |
|
Placebo Comparator Placebo |
Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT04360551
- Status
- Terminated
- Sponsor
- University of Hawaii