Clinical trial NCT04360551: Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-04-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will enroll 40 symptomatic outpatients tested positive for Coronavirus 2019 (COVID-19). Patients to be randomized 1:1 to Telmisartan (40 mg) vs placebo to be administered orally once daily x 21 days. Daily, the study patients will be asked to keep a record of the severity of their fever, dyspnea and fatigue and take their blood pressure (BP) and temperature. Study visits to occur on day 1 (entry), day 4, day 10 and day 21. Oro-pharyngeal swabs, and approximately 25 cc of blood will be collected at each study visit for safety labs and for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of inflammation, coagulation and fibrosis.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent prior to initiation of any study procedures.
* Understands and agrees to comply with planned study procedures including self testing of blood pressure daily
* Male or non-pregnant female adult ≥18 years of age at time of enrolment.
* Has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection as determined by FDA-approved commercial or public health assay in any specimen collected ideally \< 72 hours prior to randomization. Exceptions to the \<72 hr inclusion criteria may be made at the discretion of the investigator.
* Positive for COVID-19 symptoms: fever defined as a temperature of \>100.4 on study screening or self-report of daily fever at home OR shortness of breath of any degree OR fatigue causing greater than minimal interference with usual social \& functional activities
* Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study
* Able to easily swallow pills

Exclusion Criteria:

* Immediate need for hospitalization on screening
* Systolic blood pressure less than 100 mmHg
* Self-reported presence of chronic kidney disease or requiring dialysis
* Self-reported history of liver failure or untreated hepatitis B or C
* Pregnancy or breast feeding
* Allergy to the study medication
* Current use of angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) Inhibitor medications. Other blood pressure medications will be permitted in the systolic BP is higher than 90 mmHg
* Prior reaction or intolerance to ARB or ACE Inhibitor
* Use of aliskiren in patients with diabetes
* Current use of and on-going need for lithium, digoxin, potassium sparing diuretics such as spironolactone
* Current use of and need for potassium supplements
* Current or past participation in a research study within 12 weeks prior to the Screening Visit unless cleared by Study Team
* Inability to drive safely for study visits
* Subjects, who, in the opinion of the investigator, are unable to comply with the protocol evaluation, or for whom study participation may not be advisable

Primary outcomes:
measure: Maximum Clinical Severity of Disease Since Entry
timeFrame: maximum clinical severity of disease post entry evaluated over the 21 day clinical study
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: Through study completion at day 21 of study
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
state: Hawaii
Study officials:
affiliation: University of Hawaii at Manoa John A Burns School of Medicine
name: Cecilia M Shikuma, MD
role: PRINCIPAL_INVESTIGATOR
References: