INvestigating TELmisartin Study

Covid19 Clinical Trial

— INTEL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04715763
• Other study ID #: H053
• Status: Terminated
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: April 26, 2022

Study information

• Verified date: June 2022
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Telmisartan Oral Product
Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
• Placebo
Gelatin capsules filled with an inactive ingredient

Locations

Country	Name	City	State
United States	Queen's Medical Center	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	Queens Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Angiotensin 1-7 /Angiotensin II ratio	Change in Angiotensin 1-7/ Angiotensin II ratio	From entry to day 4 of study
Primary	Duration of hospitalization	Number of days of patient's hospitalization	Over the 21 day period of study
Secondary	Duration of supplemental oxygen	Median number of days patients required supplemental oxygen in each arm	over the 21 days of study
Secondary	Duration of mechanical ventilation	Median number of days patients required mechanical ventilation in each arm	over the 21 days of study
Secondary	Number of deaths	Total number of deaths during the study period in each arm	over the 21 days of study
Secondary	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
Secondary	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