Clinical trial NCT04715763: INvestigating TELmisartin Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Queens Medical Center
First posted: 2021-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to Telmisartan (80 mg) vs placebo
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of hospitalization
timeFrame: Over the 21 day period of study
Secondary outcomes:
measure: Duration of supplemental oxygen
timeFrame: over the 21 days of study
measure: Duration of mechanical ventilation
timeFrame: over the 21 days of study
measure: Number of deaths
timeFrame: over the 21 days of study
measure: Number of grade 3 and greater adverse events
timeFrame: over the 21 days of study
measure: Clinical severity of disease
timeFrame: On day 4 and day 21 of study
Other outcomes:
measure: Angiotensin 1-7 /Angiotensin II ratio
timeFrame: From entry to day 4 of study
Locations:
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
Study officials:
affiliation: University of Hawaii at Manoa John A Burns School of Medicine
name: Cecilia M Shikuma
role: PRINCIPAL_INVESTIGATOR
References: