INvestigating TELmisartin Study (INTEL)

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: Telmisartan Oral Product; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiotensin 1-7 /Angiotensin II ratio	Change in Angiotensin 1-7/ Angiotensin II ratio	From entry to day 4 of study

Collaborators and Investigators

• Sponsor: University of Hawaii
• Collaborators: Queens Medical Center
• Investigators: Principal Investigator: Cecilia M Shikuma, University of Hawaii at Manoa John A Burns School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: H053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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