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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 30, 2021

Interventions

  • Drug: Telmisartan 40mg
    • Angiotensin Receptor Blocker (ARB)
  • Drug: Placebo
    • Placebo once daily

Arms, Groups and Cohorts

  • Experimental: Telmisartan
    • Telmisartan 40 mg po daily x 21 days
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Maximum clinical severity of disease
    • Time Frame: Over the 21 day period of study
    • Based on a modified World Health Organization (WHO) COVID-19 7-point ordinal scale

Secondary Measures

  • Incidence of treatment emergent adverse events
    • Time Frame: Through study completion at day 21 of study
    • Number of adverse events grade 2 and above utilizing the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014
  • Renin angiotensin system peptides
    • Time Frame: At each study time point (day 4, day 10, day 21)
    • Angiotensin I (AngI), AngII, Ang1-9 and Ang1-7
  • Plasma biomarkers
    • Time Frame: At each study time point (day 4, day 10, day 21)
    • plasma biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion by Luminex multiplexing assays such as TNF-alpha, IL-6, CK-MB, Troponin I, Fractalkine, MCP-1, PD-1, TIMP-1

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Hawaii
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cecilia M Shikuma, MD, Principal Investigator, University of Hawaii at Manoa John A Burns School of Medicine
  • Overall Contact(s)
    • Cecilia M Shikuma, MD, 808 692-1328, shikuma@hawaii.edu

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