INvestigating TELmisartin Study

NCT04715763 | Terminated Phase 2 FDA Drug

• 1 other identifier: H053
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalization

  Number of days of patient's hospitalization

  Over the 21 day period of study

Secondary Outcomes (5)

• Duration of supplemental oxygen

  over the 21 days of study

• Duration of mechanical ventilation

  over the 21 days of study

• Number of deaths

  over the 21 days of study

• Number of grade 3 and greater adverse events

  over the 21 days of study

• Clinical severity of disease

  On day 4 and day 21 of study

Other Outcomes (1)

• Angiotensin 1-7 /Angiotensin II ratio

  From entry to day 4 of study

Study Arms (2)

Telmisartan (80 mg)

ACTIVE COMPARATOR

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

Drug: Telmisartan Oral Product

Placebo

PLACEBO COMPARATOR

Two placebo capsules given orally each day x 21 days

Drug: Placebo

Interventions

Telmisartan Oral Product DRUG

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

Also known as: Micardis

Telmisartan (80 mg)

Placebo DRUG

Gelatin capsules filled with an inactive ingredient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead
• Queens Medical Center: collaborator

Study Sites (1)

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cecilia M Shikuma

  University of Hawaii at Manoa John A Burns School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: September 1, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)