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

Sponsor

University of Hawaii (Other)

Overall Status

Terminated

CT.gov ID

NCT04360551

Collaborator

(none)

Enrollment

Location

Arms

21.8

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Telmisartan 40mg Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Placebo controlled trial

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Apr 26, 2022

Actual Study Completion Date :

Apr 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telmisartan Telmisartan 40 mg po daily x 21 days	Drug: Telmisartan 40mg Angiotensin Receptor Blocker (ARB)
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo once daily

Arm

Intervention/Treatment

Experimental: Telmisartan

Telmisartan 40 mg po daily x 21 days

Drug: Telmisartan 40mg

Angiotensin Receptor Blocker (ARB)

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Placebo once daily

Outcome Measures

Primary Outcome Measures

Maximum clinical severity of disease [Over the 21 day period of study]
Based on a modified World Health Organization (WHO) COVID-19 7-point ordinal scale

Secondary Outcome Measures

Incidence of treatment emergent adverse events [Through study completion at day 21 of study]
Number of adverse events grade 2 and above utilizing the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014
Renin angiotensin system peptides [At each study time point (day 4, day 10, day 21)]
Angiotensin I (AngI), AngII, Ang1-9 and Ang1-7
Plasma biomarkers [At each study time point (day 4, day 10, day 21)]
plasma biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion by Luminex multiplexing assays such as TNF-alpha, IL-6, CK-MB, Troponin I, Fractalkine, MCP-1, PD-1, TIMP-1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako	Honolulu	Hawaii	United States	96813

Sponsors and Collaborators

University of Hawaii

Investigators

Principal Investigator: Cecilia M Shikuma, MD, University of Hawaii at Manoa John A Burns School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Hawaii

ClinicalTrials.gov Identifier:

NCT04360551

Other Study ID Numbers:

H051

First Posted:

Apr 24, 2020

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

COVID-19

Telmisartan

Study Results

No Results Posted as of Jul 1, 2022