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

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ClinicalTrials.gov Identifier: NCT04360551
Recruitment Status : Terminated (Decrease in COVID-19 cases locally)
First Posted : April 24, 2020
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

Tracking Information
First Submitted Date  ICMJE April 21, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date July 1, 2022
Actual Study Start Date  ICMJE July 1, 2020
Actual Primary Completion Date April 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Placebo controlled trial
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Telmisartan 40mg
    Angiotensin Receptor Blocker (ARB)
  • Drug: Placebo
    Placebo once daily
Study Arms  ICMJE
  • Experimental: Telmisartan
    Telmisartan 40 mg po daily x 21 days
    Intervention: Drug: Telmisartan 40mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 27, 2022)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
40
Actual Study Completion Date  ICMJE April 26, 2022
Actual Primary Completion Date April 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04360551
Other Study ID Numbers  ICMJE H051
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Current Responsible Party University of Hawaii
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Hawaii
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cecilia M Shikuma, MD University of Hawaii at Manoa John A Burns School of Medicine
PRS Account University of Hawaii
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP