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INvestigating TELmisartin Study (INTEL)

Primary Purpose

Covid19

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Telmisartan Oral Product

Placebo

About this trial

This is an interventional treatment trial for Covid19

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.
Within 72 hours of initial hospitalization for acute COVID-19 disease management
Male or non-pregnant female adult ≥18 years of age at time of enrolment.
Able to easily swallow pills

Exclusion Criteria:

Systolic blood pressure less than 100 mmHg
Self-reported history of decompensated liver failure
Pregnancy or breast feeding
Allergy to the study medication
Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNIs). Blood pressure medications in other classes will be permitted as long as the systolic BP is >100 mmHg
Currently receiving vasopressors for hypotension
Prior reaction or intolerance to ARB, ACE Inhibitor or ANRI for whom study participation would not be advisable in the opinion of the study team
Current use of and on-going need for aliskiren, lithium, digoxin, and potassium sparing diuretics such as spironolactone
Participating in other drug clinical trials EXCEPT for other COVID-19 treatment trials which will be allowed with the permission of the Corresponding PI or Co-PI and concurrence of the treating physician/hospitalist
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10x upper limit of normal (ULN) within 24 hours of baseline
Absolute neutrophil count (ANC) < 1000/mL within 24 hours of baseline
Platelet count < 50,000/mL within 24 hours of baseline.
Patients with acute kidney injury (AKI) or chronic kidney disease (CKD) including individuals on hemodialysis may be enrolled based on the investigator's clinical judgement.
Any serious medical condition/ abnormality or other issues that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or suggests that the study is not in the patient's best interest
In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments

Sites / Locations

Queen's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Telmisartan (80 mg)

Placebo

Arm Description

Telmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days

Two placebo capsules given orally each day x 21 days

Outcomes

Primary Outcome Measures

Duration of hospitalization

Number of days of patient's hospitalization

Secondary Outcome Measures

Duration of supplemental oxygen

Median number of days patients required supplemental oxygen in each arm

Duration of mechanical ventilation

Median number of days patients required mechanical ventilation in each arm

Number of deaths

Total number of deaths during the study period in each arm

Number of grade 3 and greater adverse events

Total number of Grade 3 and greater adverse events that occurred in each arm

Clinical severity of disease

Clinical severity of disease as assessed by WHO Clinical Status ordinal scale (scores range from minimum value of 1 (not hospitalized, no limitations on activities) to maximum value of 7 (death); higher is worse outcome.

Full Information

NCT ID

NCT04715763

First Posted

January 14, 2021

Last Updated

June 27, 2022

Sponsor

University of Hawaii

Collaborators

Queens Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04715763

Brief Title

INvestigating TELmisartin Study

Acronym

INTEL

Official Title

Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment due to decrease in COVID-19 rates locally

Study Start Date

September 1, 2021 (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

Queens Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.

Detailed Description

The study is intended to assess, in a pilot study, the effect of telmisartan in mitigating the severity of COVID-19 related disease in hospitalized patients. Data on clinical course and lab values will be passively abstracted from Queen's standard of care evaluations on COVID-19 in-patients. Participants will be monitored closely as an outpatient if/when discharged prior to day 21. The only study-specific procedure will be a blood draw of ten (10) cc to be collected for research purposes at entry and at day 4 and day 21 of study for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion.

6. Conditions and Keywords

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

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized 1:1 to Telmisartan (80 mg) vs placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telmisartan (80 mg)

Arm Type

Active Comparator

Arm Description

Telmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Two placebo capsules given orally each day x 21 days

Intervention Type

Drug

Intervention Name(s)

Telmisartan Oral Product

Other Intervention Name(s)

Micardis

Intervention Description

Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Gelatin capsules filled with an inactive ingredient

Primary Outcome Measure Information:

Title

Duration of hospitalization

Description

Number of days of patient's hospitalization

Time Frame

Over the 21 day period of study

Secondary Outcome Measure Information:

Title

Duration of supplemental oxygen

Description

Median number of days patients required supplemental oxygen in each arm

Time Frame

over the 21 days of study

Title

Duration of mechanical ventilation

Description

Median number of days patients required mechanical ventilation in each arm

Time Frame

over the 21 days of study

Title

Number of deaths

Description

Total number of deaths during the study period in each arm

Time Frame

over the 21 days of study

Title

Number of grade 3 and greater adverse events

Description

Total number of Grade 3 and greater adverse events that occurred in each arm

Time Frame

over the 21 days of study

Title

Clinical severity of disease

Description

Time Frame

On day 4 and day 21 of study

Other Pre-specified Outcome Measures:

Title

Angiotensin 1-7 /Angiotensin II ratio

Description

Change in Angiotensin 1-7/ Angiotensin II ratio

Time Frame

From entry to day 4 of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to provide written informed consent prior to initiation of any study procedures. Within 72 hours of initial hospitalization for acute COVID-19 disease management Male or non-pregnant female adult ≥18 years of age at time of enrolment. Able to easily swallow pills Exclusion Criteria: Systolic blood pressure less than 100 mmHg Self-reported history of decompensated liver failure Pregnancy or breast feeding Allergy to the study medication Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNIs). Blood pressure medications in other classes will be permitted as long as the systolic BP is >100 mmHg Currently receiving vasopressors for hypotension Prior reaction or intolerance to ARB, ACE Inhibitor or ANRI for whom study participation would not be advisable in the opinion of the study team Current use of and on-going need for aliskiren, lithium, digoxin, and potassium sparing diuretics such as spironolactone Participating in other drug clinical trials EXCEPT for other COVID-19 treatment trials which will be allowed with the permission of the Corresponding PI or Co-PI and concurrence of the treating physician/hospitalist Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10x upper limit of normal (ULN) within 24 hours of baseline Absolute neutrophil count (ANC) < 1000/mL within 24 hours of baseline Platelet count < 50,000/mL within 24 hours of baseline. Patients with acute kidney injury (AKI) or chronic kidney disease (CKD) including individuals on hemodialysis may be enrolled based on the investigator's clinical judgement. Any serious medical condition/ abnormality or other issues that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or suggests that the study is not in the patient's best interest In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cecilia M Shikuma

Organizational Affiliation

University of Hawaii at Manoa John A Burns School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen's Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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INvestigating TELmisartin Study

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