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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360551
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Telmisartan 40mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Placebo controlled trial
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan
Telmisartan 40 mg po daily x 21 days
Drug: Telmisartan 40mg
Angiotensin Receptor Blocker (ARB)

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo once daily




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360551


Contacts
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Contact: Cecilia M Shikuma, MD 808 692-1328 shikuma@hawaii.edu
Contact: Debra Ogata-Arakaki, RN 808 692-1332 ogataara@hawaii.edu

Locations
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United States, Hawaii
University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
Investigators
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Principal Investigator: Cecilia M Shikuma, MD University of Hawaii at Manoa John A Burns School of Medicine
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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT04360551    
Other Study ID Numbers: H051
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action