NCT04615871: SEMPATICO

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

Status unknown Phase 2 Last updated 8 February 2022

What this trial tests

Phase 2 trial testing semaglutide in Covid19 in 400 participants. Status unknown.

Timeline

10 September 2021

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Vladimír Džavík
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	400
Start date	10 September 2021
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	10 locations across United Kingdom, Canada, Brazil, Mexico

Drugs / interventions tested

• semaglutide (semaglutide) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →
• Myocardial Injury — all drugs for Myocardial Injury →

Sponsor

Vladimír Džavík

Who can join

18 and older, any sex, with Covid19 or Myocardial Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 participants will 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 1 week (7-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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
   Mahapatra MK, Karuppasamy M, Sahoo BM. · · 2022 · cited 92× · PMID 34993760 · DOI 10.1007/s11154-021-09699-1
2. Association Between Glucagon-Like Peptide 1 Receptor Agonist and Sodium-Glucose Cotransporter 2 Inhibitor Use and COVID-19 Outcomes.
   Kahkoska AR, Abrahamsen TJ, Alexander GC, Bennett TD, et al · · 2021 · cited 48× · PMID 34135013 · DOI 10.2337/dc21-0065
3. COVID-19 and metabolic syndrome.
   Dissanayake H. · · 2023 · cited 19× · PMID 36907785 · DOI 10.1016/j.beem.2023.101753
4. Use of Novel Antidiabetic Agents in Patients with Type 2 Diabetes and COVID-19: A Critical Review.
   Popovic DS, Papanas N, Pantea Stoian A, Rizvi AA, et al · · 2021 · cited 16× · PMID 34699021 · DOI 10.1007/s13300-021-01170-3
5. Severe COVID-19 and non-COVID-19 severe sepsis converge transcriptionally after a week in the intensive care unit, indicating common disease mechanisms.
   An AY, Baghela A, Zhang P, Falsafi R, et al · · 2023 · cited 15× · PMID 37090709 · DOI 10.3389/fimmu.2023.1167917
6. L-arginine as a potential GLP-1-mediated immunomodulator of Th17-related cytokines in people with obesity and asthma.
   Liao SY, Linderholm A, Showalter MR, Chen CH, et al · · 2021 · cited 10× · PMID 34123401 · DOI 10.1002/osp4.500
7. Dipeptidyl Peptidase-4 Inhibitors, Glucagon-like Peptide-1 Receptor Agonists, and Sodium-Glucose Cotransporter-2 Inhibitors and COVID-19 Outcomes.
   Foresta A, Ojeda-Fernandez L, Macaluso G, Roncaglioni MC, et al · · 2023 · cited 7× · PMID 36933975 · DOI 10.1016/j.clinthera.2023.02.007
8. Persistence is key: unresolved immune dysfunction is lethal in both COVID-19 and non-COVID-19 sepsis.
   An AY, Baghela A, Zhang P, Falsafi R, et al · · 2023 · cited 4× · PMID 37822940 · DOI 10.3389/fimmu.2023.1254873