Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 (SEMPATICO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04615871|
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
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
- Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|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|
|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|
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.
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.
- Composite of death or mechanical ventilation [ Time Frame: 28 days after randomization ]All cause death or invasive or non-invasive mechanical ventilation
- 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.
- 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.
- 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
- 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
- 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.
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
|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 email@example.com|
|Principal Investigator: Andrei C Sposito, MD|
|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 firstname.lastname@example.org|
|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|
|McGill University Health Centre|
|Montréal, Quebec, Canada|
|Contact: Sarah Elsayed (514)934-1934 ext 23730 email@example.com|
|Principal Investigator: Emily McDonald, MD|
|Hospital de Infectologia|
|Mexico City, Mexico|
|Contact: Daniela M Rosiles, MD firstname.lastname@example.org|
|Principal Investigator: Eduardo Mateos, MD|
|Hospital General Regional|
|Mexico City, Mexico|
|Contact: Beatriz Villegas, DDS email@example.com|
|Principal Investigator: Jorge Escobedo, MD|
|Hospital Regional 2|
|Contact: Juan A Santillan, MD firstname.lastname@example.org|
|Principal Investigator: Julieta Valenzuela, MD|
|Sandwell and West Birmingham NHS Trust|
|Birmingham, United Kingdom, B18 7QH|
|Contact: Gina Dutton 44 (0) 121 507 4811 email@example.com|
|Principal Investigator: Vinoda Sharma, MD|
|Principal Investigator:||Vladimir Dzavik, MD||University Health Network, Toronto|