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SEMPATICO

UnknownPhase 2

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 Randomized Controlled Trial

Lead sponsor

Vladimír Džavík

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

400

estimated

Study population

COVID / long COVID

Key I/E criteria

•BMI ≥30•eGFR ≤60

Primary endpoint

•Composite of death or mechanical ventilation (All-cause death, mechanical ventilation invasive, mechanical ventilation noninvasive)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04615871

Org study IDUHNSEMPATICO1

Timeline

Milestones

Study first posted2020-11-04actual

Study start2021-09-10actual

Last update posted2022-02-08actual

Primary completion2022-03-31estimated

Study completion2022-03-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

COVID / long COVID

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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 need for any O2 therapy

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

•Breastfeeding, if they intend to continue breastfeeding

•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 with high flow nasal cannula at FiO2 >50% or already on mechanical ventilation

•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 from patient or Substitute Decision Maker (SDM)

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

cardiac troponin level

Time frame:14±2 days after randomization

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

ECG

Time frame:Day 7±2 and Day 14±2

descriptive

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Composite of death or mechanical ventilation

Time frame:28 days after randomization

composite event, event

componentsAll-cause death, mechanical ventilation invasive, mechanical ventilation noninvasive

Secondary/protocol endpoint/low confidence

28-day organ support-free days

Time frame:28 days

event count, improvement

Secondary/protocol endpoint/low confidence

A composite of death or intensification of medical therapy

Time frame:180 days

composite event, event

componentsAll-cause death, ecls need, mechanical ventilation need, vasopressor inotrope need

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

cardiac troponin level

Time frame:7±2 days after randomization

threshold achievement, event

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Persistence is key: unresolved immune dysfunction is lethal in both COVID-19 and non-COVID-19 sepsis.
Frontiers in immunology2023 (year)PMID37822940doi:10.3389/fimmu.2023.1254873via pubmed nct search
Severe COVID-19 and non-COVID-19 severe sepsis converge transcriptionally after a week in the intensive care unit, indicating common disease mechanisms.
Frontiers in immunology2023 (year)PMID37090709doi:10.3389/fimmu.2023.1167917via pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.