Status:
TERMINATED
Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04360551
Start Date
July 1 2020
End Date
April 26 2022
Last Update
August 21 2023
Active Locations (1)
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1
University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
Honolulu, Hawaii, United States, 96813