INvestigating TELmisartin Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Telmisartan Oral Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1 to Telmisartan (80 mg) vs placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telmisartan (80 mg)<br>Telmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days | Drug: Telmisartan Oral Product<br>* Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction<br>* Other names: Micardis;|
| Placebo Comparator: Placebo<br>Two placebo capsules given orally each day x 21 days | Drug: Placebo<br>* Gelatin capsules filled with an inactive ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | Number of days of patient's hospitalization | Over the 21 day period of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of supplemental oxygen | Median number of days patients required supplemental oxygen in each arm | over the 21 days of study | 
| Duration of mechanical ventilation | Median number of days patients required mechanical ventilation in each arm | over the 21 days of study | 
| Number of deaths | Total number of deaths during the study period in each arm | over the 21 days of study | 
| Number of grade 3 and greater adverse events | Total number of Grade 3 and greater adverse events that occurred in each arm | over the 21 days of study | 
| 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. | On day 4 and day 21 of study |