INvestigating TELmisartin Study

NCT ID: NCT04715763

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-04-26

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Telmisartan (80 mg)

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

Group Type: ACTIVE_COMPARATOR

Telmisartan Oral Product

Intervention Type: DRUG

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

Placebo

Two placebo capsules given orally each day x 21 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Gelatin capsules filled with an inactive ingredient

Interventions

Telmisartan Oral Product

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

Intervention Type: DRUG

Placebo

Gelatin capsules filled with an inactive ingredient

Intervention Type: DRUG

Other Intervention Names

Micardis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queens Medical Center

UNKNOWN

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia M Shikuma

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii at Manoa John A Burns School of Medicine

Locations

Queen's Medical Center

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

H053

Identifier Type: -

Identifier Source: org_study_id