Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

Sponsor
Vladimír Džavík
Study ID
NCT04615871
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    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

Study Details

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.

Key Dates

Start date
Sep 10, 2021
Status verified
Jan 2022
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Composite of death or mechanical ventilation [ Time Frame: 28 days after randomization ]

Central Contacts

Related Studies