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Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

Plain-language guide to NCT04615871: phase 2 randomized trial of Semaglutide, 400 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04615871
Phase
phase 2
Status
status unknown
Start
2021-09-10
Completion (planned or actual)
2022-03-31
Participants
400 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Covid19; Myocardial Injury
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE).

It had two arms (groups): semaglutide (experimental) and control (no intervention).

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

The registry classes the interventions as drug.

More on the Plan

ARDS was also more common in troponin-positive patients.

Currently there is a paucity of approved therapies for COVID-19 infection.

Current interventions are either supportive in nature or experimental anti-viral, anti-inflammatory, or anti-coagulant in nature.

The investigators have strong rationale and world-leading expertise in this area.

Who Took Part

The registry lists 400 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 60 years. Obesity (BMI \>30). Hypertension (on treatment or recently diagnosed)h. Coronary artery, cerebrovascular or peripheral vascular disease∫.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: age \<18 years; history of pancreatitis; history of multiple endocrine neoplasia or medullary thyroid cancer.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-09-10 with completion listed for 2022-03-31.

It ran at 10 sites in Canada (4), Mexico (3), Brazil (2) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example cardiac troponin level, cardiac troponin level, ECG and 28-day organ support-free days.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 400 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.