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Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 (SEMPATICO)

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ClinicalTrials.gov Identifier: NCT04615871
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Unity Health Toronto
Canadian Institutes of Health Research (CIHR)
University of Toronto
Information provided by (Responsible Party):
Vladimír Džavík, University Health Network, Toronto

Brief Summary:

With the results of this study the investigators aim to identify an effective treatment that will reduce morbidity and mortality of patients with symptomatic COVID-19 infection, which would in turn reduce the burden on the healthcare system by decreasing the need for intensive care.

Objectives: The main objective of this research is to determine if once weekly treatment with the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiac complications of COVID-19 infection.

Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced risk profile as described above, who have been admitted to hospital due to symptoms of COVID-19 infection but do not as yet require critical care will be approached to participate in this study. Provided there are no exclusion criteria and the participants agree by means of documented written informed consent, The participants the participantswill be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately after randomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn at Day 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG will be obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28.

Primary outcome measure: A composite of (1) death from any cause or (2) mechanical ventilation (invasive or non-invasive) at 28 days.

Major secondary outcome measure:

(1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at Day 7±2 days and Day 14±2 days post randomization.

Other major secondary outcome measure:

A composite of

  1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days
  2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.

Condition or disease Intervention/treatment Phase
Covid19 Myocardial Injury Drug: semaglutide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive active treatment - s.c. semaglutide for 4 weekly doses in addition to standard of care or control - standard of care only
Masking: Single (Outcomes Assessor)
Masking Description: Randomized open-label blinded evaluation trial. There will be an independent events adjudication committee
Primary Purpose: Treatment
Official Title: Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 Randomized Controlled Trial
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: semaglutide
Eligible subjects randomized to this arm will receive semaglutide 0.25 mg s.c. after randomization (Day 0), then semaglutide 0.5 mg s.c. on Day 7, Day 14 and Day 21 in addition to standard of care.
Drug: semaglutide
semaglutide 0.25 mg s.c. on Day 0 after randomization, then semaglutide 0.5 mg s.c. on Day 7, Day 14 and Day 21
Other Name: Ozempic

No Intervention: control
Eligible subjects randomized to the control arm will receive no active treatment, only standard of care.



Primary Outcome Measures :
  1. Composite of death or mechanical ventilation [ Time Frame: 28 days after randomization ]
    All cause death or invasive or non-invasive mechanical ventilation


Secondary Outcome Measures :
  1. cardiac troponin level [ Time Frame: 7±2 days after randomization ]
    (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days) post randomization.

  2. cardiac troponin level [ Time Frame: 14±2 days after randomization ]
    (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days) post randomization.

  3. ECG [ Time Frame: Day 7±2 and Day 14±2 ]
    The ECG will be evaluated for deviation from normal or from baseline (QRS, ST-T wave changes

  4. 28-day organ support-free days [ Time Frame: 28 days ]

    The number of days that a patient is alive and free of organ support through 28 days after trial entry. Organ support is defined by receipt for non-invasive mechanical ventilation, high flow nasal cannula oxygen, mechanical ventilation, or vasopressor therapy.

    Non-invasive mechanical ventilation is defined as bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) when used for acute respiratory support (Use of BIPAP or CPAP at night or when sleeping for sleep apnea is not considered organ support) High Flow Nasal Cannula Oxygen: defined as receiving ≥30 l/min flow at FiO2 ≥40% Invasive mechanical ventilation is defined as positive pressure ventilation through endotracheal tube or tracheostomy Vasopressor support includes infusion of any vasoactive or inotropic medication


  5. A composite of death or intensification of medical therapy [ Time Frame: 180 days ]
    Intensification of medical therapy includes the need for ECLS, mechanical ventilation (invasive or non-invasive [BIPAP]) and/or vasopressor/inotropic therapy on Day 180 post randomization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Symptomatic* COVID-2 infection confirmed by a positive COVID-19 test requiring hospitalization [or equivalent health care setting] with any two of the following high-risk features:

  • age ≥ 60 years
  • obesity (BMI >30)
  • diabetes mellitus
  • hypertension (on treatment or recently diagnosed)h
  • coronary artery, cerebrovascular or peripheral vascular disease∫
  • chronic kidney disease (CKD) [eGFR <60 mL/min/1.73m2 using the CKD Epidemiology Collaboration equation
  • admission troponin >99% of ULN
  • admission d-dimer > 1µg/ml
  • O2 saturation ≤93% e on room air or ≤95% on O2 therapy at 1-4 LPM

Exclusion Criteria:

  • Age <18 years
  • History of pancreatitis
  • History of multiple endocrine neoplasia or medullary thyroid cancer
  • Current use of a GLP-1 receptor agonist [use of a DPP-4 inhibitor is allowed]
  • Positive beta-HCG (pregnancy test is mandated with baseline bloodwork for all female subjects ≤50 years of age
  • Elevation of serum lipase, direct (conjugated) bilirubin, or alkaline phosphatase (ALP) more than 3X the upper limit of normal on baseline bloodwork
  • history of decompensated heart failure with reduced ejection fraction (<35%) within 90 days, or known stable NYHA class IV heart failure prior to their COVID-19 illness
  • imminent mechanical ventilation or death
  • O2 therapy >4 LPM by nasal cannula or mask or already receiving non-invasive mechanical ventilation on enrolment
  • Any marker of hemodynamic instability at baseline defined as persistent SBP <90 mmHg after rehydration, or > 220 mmHg after receiving routine antihypertensive therapy, or HR <50 bpm or > 140 bpm after rehydration.
  • inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615871


Locations
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Brazil
Instituto Prevent Senior
São Paulo, Brazil
Contact: Priscilla Griffo       Priscilla.Griffo@institutopreventsenior.com.br   
Principal Investigator: Rodrigo B Esper, MD         
State University of Campinas
São Paulo, Brazil
Contact: Ticiane Bovi       ticianenutri@gmail.com   
Principal Investigator: Andrei C Sposito, MD         
Canada, Ontario
Trillium Health Partners
Mississauga, Ontario, Canada
Contact: Anil Gupta, MD         
Principal Investigator: Anil Gupta, MD         
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Contact: Carlos Fernando    416-864-6060 ext 46969    carlos.fernando@unityhealth.to   
Principal Investigator: Kim Connelly, MD         
University Health Network - Peter Munk Cardiac Centre
Toronto, Ontario, Canada
Contact: Cheryl Geen-Smith    416-340-4800 ext 4969    Cheryl.Geen-Smith@uhn.ca   
Principal Investigator: Vladimír Džavík, MD         
Principal Investigator: Mansoor Husain, MD         
Canada, Quebec
McGill University Health Centre
Montréal, Quebec, Canada
Contact: Sarah Elsayed    (514)934-1934 ext 23730    sarah.elsayed@mail.mcgill.ca   
Principal Investigator: Emily McDonald, MD         
Mexico
Hospital de Infectologia
Mexico City, Mexico
Contact: Daniela M Rosiles, MD       danierof@gmail.com   
Principal Investigator: Eduardo Mateos, MD         
Hospital General Regional
Mexico City, Mexico
Contact: Beatriz Villegas, DDS       beatrizvillegaslara@gmail.com   
Principal Investigator: Jorge Escobedo, MD         
Hospital Regional 2
Querétaro, Mexico
Contact: Juan A Santillan, MD       anwarsantillan30@gmail.com   
Principal Investigator: Julieta Valenzuela, MD         
United Kingdom
Sandwell and West Birmingham NHS Trust
Birmingham, United Kingdom, B18 7QH
Contact: Gina Dutton    44 (0) 121 507 4811    gina.dutton1@nhs.net   
Principal Investigator: Vinoda Sharma, MD         
Sponsors and Collaborators
Vladimír Džavík
Unity Health Toronto
Canadian Institutes of Health Research (CIHR)
University of Toronto
Investigators
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Principal Investigator: Vladimir Dzavik, MD University Health Network, Toronto
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Responsible Party: Vladimír Džavík, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04615871    
Other Study ID Numbers: UHNSEMPATICO1
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vladimír Džavík, University Health Network, Toronto:
Covid-19
myocardial injury
GLP-1 agonist
semaglutide
Additional relevant MeSH terms:
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Wounds and Injuries