search
Back to results

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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telmisartan 40mg
Placebo
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Telmisartan

Placebo

Arm Description

Telmisartan 40 mg po daily x 21 days

Placebo

Outcomes

Primary Outcome Measures

Maximum Clinical Severity of Disease Since Entry
We utilized the World Health Organization (WHO) COVID-19 7-point ordinal scale: 1 (not hospitalized, no limitations on activities), 2 (not hospitalized limitation on activities); 3 (hospitalized, not requiring oxygen); 4 (hospitalized and requiring oxygen); 5 (hospitalized, on non-invasive ventilation or high flow oxygen devices); 6 (hospitalized, on invasive mechanical ventilation or ECMO) and 7 (death). A symptom scale was devised to allow 'fine tuning' within the 2.0 WHO category of 'not hospitalized but limitation on activities' based on severity (no symptoms, mild, moderate, moderately severe and severe symptoms) of fever, breathing and fatigue severity scale (0 to 4 points for each factor allowing a max score of 12). A WHO scale within the '2' category was then 'fine tuned' as follows: 2.0 (</=3 symptom points), 2.25 (4-6 symptom points), 2.5 (7-9 symptom points), and 2.75 (10-12 symptom points).

Secondary Outcome Measures

Number of Adverse Events
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

Full Information

First Posted
April 21, 2020
Last Updated
August 16, 2023
Sponsor
University of Hawaii
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT04360551
Brief Title
Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Decrease in COVID-19 cases locally
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Placebo controlled trial
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Telmisartan 40 mg po daily x 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Telmisartan 40mg
Intervention Description
Angiotensin Receptor Blocker (ARB)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Maximum Clinical Severity of Disease Since Entry
Description
We utilized the World Health Organization (WHO) COVID-19 7-point ordinal scale: 1 (not hospitalized, no limitations on activities), 2 (not hospitalized limitation on activities); 3 (hospitalized, not requiring oxygen); 4 (hospitalized and requiring oxygen); 5 (hospitalized, on non-invasive ventilation or high flow oxygen devices); 6 (hospitalized, on invasive mechanical ventilation or ECMO) and 7 (death). A symptom scale was devised to allow 'fine tuning' within the 2.0 WHO category of 'not hospitalized but limitation on activities' based on severity (no symptoms, mild, moderate, moderately severe and severe symptoms) of fever, breathing and fatigue severity scale (0 to 4 points for each factor allowing a max score of 12). A WHO scale within the '2' category was then 'fine tuned' as follows: 2.0 (</=3 symptom points), 2.25 (4-6 symptom points), 2.5 (7-9 symptom points), and 2.75 (10-12 symptom points).
Time Frame
maximum clinical severity of disease post entry evaluated over the 21 day clinical study
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
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
Time Frame
Through study completion at day 21 of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia M Shikuma, MD
Organizational Affiliation
University of Hawaii at Manoa John A Burns School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs