INvestigating TELmisartin Study (INTEL)

University of Hawaii

Status and phase

Terminated

Phase 2

Conditions

Covid19

Treatments

Drug: Placebo

Drug: Telmisartan Oral Product

Study type

Interventional

Funder types

Other

Identifiers

NCT04715763

H053

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No 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