Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

NCT ID: NCT04360551

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-04-26

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Telmisartan

Telmisartan 40 mg po daily x 21 days

Group Type: EXPERIMENTAL

Telmisartan 40mg

Intervention Type: DRUG

Angiotensin Receptor Blocker (ARB)

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo once daily

Interventions

Telmisartan 40mg

Angiotensin Receptor Blocker (ARB)

Intervention Type: DRUG

Placebo

Placebo once daily

Intervention Type: DRUG

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia M Shikuma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii at Manoa John A Burns School of Medicine

Locations

University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako

Honolulu, Hawaii, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U54MD007601-34S3

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H051

Identifier Type: -

Identifier Source: org_study_id