Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19
Status:
Not yet recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Vladimír Džavík
Collaborators:
Canadian Institutes of Health Research (CIHR) St. Michael's Hospital, Toronto Unity Health Toronto University of Toronto