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History of Changes for Study: NCT04360551
Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
Latest version (submitted June 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 22, 2020 None (earliest Version on record)
2 July 30, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 June 27, 2022 Recruitment Status, Study Status, Contacts/Locations, IPDSharing and Study Design
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Study NCT04360551
Submitted Date:  April 22, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: H051
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: July 1, 2020
Primary Completion: June 30, 2021 [Anticipated]
Study Completion: June 30, 2021 [Anticipated]
First Submitted: April 21, 2020
First Submitted that
Met QC Criteria:
April 22, 2020
First Posted: April 24, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 22, 2020
Last Update Posted: April 24, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Hawaii
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Maximum clinical severity of disease
[ Time Frame: Over the 21 day period of study ]

Based on a modified World Health Organization (WHO) COVID-19 7-point ordinal scale
Secondary Outcome Measures:
1. Incidence of treatment emergent adverse events
[ Time Frame: 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
2. Renin angiotensin system peptides
[ Time Frame: At each study time point (day 4, day 10, day 21) ]

Angiotensin I (AngI), AngII, Ang1-9 and Ang1-7
3. Plasma biomarkers
[ Time Frame: 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Cecilia M Shikuma, MD
Telephone: 808 692-1328
Email: shikuma@hawaii.edu
Central Contact Backup: Debra Ogata-Arakaki, RN
Telephone: 808 692-1332
Email: ogataara@hawaii.edu
Study Officials: Cecilia M Shikuma, MD
Principal Investigator
University of Hawaii at Manoa John A Burns School of Medicine
Locations: United States, Hawaii
University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
Honolulu, Hawaii, United States, 96813
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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