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TERMINATEDPHASE2

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

Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

NCT04360551•University of Hawaii

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
•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
+4 more criteria

Locations (1)

University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako

Honolulu, Hawaii, United States

Key Dates

Start Date

July 1, 2020

Primary Completion Date

April 26, 2022

Completion Date

April 26, 2022

Last Updated

August 21, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Telmisartan 40mg

DRUG

Placebo

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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