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

NCT04360551 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: H051U54MD007601-34S3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maximum Clinical Severity of Disease Since Entry

  We utilized the World Health Organization (WHO) COVID-19 7-point ordinal scale: 1 (not hospitalized, no limitations on activities), 2 (not hospitalized limitation on activities); 3 (hospitalized, not requiring oxygen); 4 (hospitalized and requiring oxygen); 5 (hospitalized, on non-invasive ventilation or high flow oxygen devices); 6 (hospitalized, on invasive mechanical ventilation or ECMO) and 7 (death). A symptom scale was devised to allow 'fine tuning' within the 2.0 WHO category of 'not hospitalized but limitation on activities' based on severity (no symptoms, mild, moderate, moderately severe and severe symptoms) of fever, breathing and fatigue severity scale (0 to 4 points for each factor allowing a max score of 12). A WHO scale within the '2' category was then 'fine tuned' as follows: 2.0 (\</=3 symptom points), 2.25 (4-6 symptom points), 2.5 (7-9 symptom points), and 2.75 (10-12 symptom points).

  maximum clinical severity of disease post entry evaluated over the 21 day clinical study

Secondary Outcomes (1)

• Number of Adverse Events

  Through study completion at day 21 of study

Study Arms (2)

Telmisartan

EXPERIMENTAL

Telmisartan 40 mg po daily x 21 days

Drug: Telmisartan 40mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Telmisartan 40mg DRUG

Angiotensin Receptor Blocker (ARB)

Telmisartan

Placebo DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

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

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The number of individuals involved in the study was extremely small. The study was terminated early because the number of infections in the community substantially decreased. As an outpatient study, the study only involved individuals with mild to moderate COVID-19 infection, as those severely ill with acute COVID-19 infections may have been hospitalized.

Results Point of Contact

• Title: Cecilia M. Shikuma MD
• Organization: University of Hawaii at Manoa John A Burns School of Medicine

shikuma@hawaii.edu

808 692-1328

Study Officials

• Cecilia M Shikuma, MD

  University of Hawaii at Manoa John A Burns School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: July 1, 2020
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)