Semaglutide to reduce Myocardial injury in PATIents with COVID-19 (SEMPATICO): An exploratory randomized controlled clinical trial

The current COVID-19 pandemic has now affected over 4.1 million people with almost 300,000 deaths. In Canada, there are almost 70,000 cases and over 5100 deaths. There is no decline in the spread of this infection. The virus can cause heart damage in up to 28% of affected patients, with over half of these patients who develop heart damage not surviving their infection. Scientists believe that the virus may cause direct damage of heart cells, or a storm of molecules that cause inflammation, and small blood vessel clots that starve the heart of oxygen. In animal studies, damage is reduced by new diabetes drugs, known as GLP-1 receptor agonists (GLP-1RA) already approved for the treatment of diabetes. Important studies show that GLP-1RA lower the risk of heart attack, stroke and death in patients with diabetes, and that small molecules generated by GLP-1RA directly protect cell of heart blood vessels. The clinical data are so promising with GLP-1RA, that this drug class is now being studied in obese non-diabetic patients at high risk of CV disease. Based on this evidence our hypothesis is that the GLP-1RA semaglutide (Ozempic - Novo Nordisk) will reduce heart damage caused by COVID-19, by protecting heart blood vessels cells. We hypothesize that these effects will reduce the need for patients to need a hospital, a ventilator, and reduce the risk of death. Our target population includes symptomatic COVID-19 patients who are at home or hospitalized, but not (yet) in an intensive care unit (ICU). By random assignment (by chance), they will be assigned to receive a once-weekly simple-to-self-administer painless "pen-click" subcutaneous injection of semaglutide or placebo for a total of 4 weeks. We will keep track of how many patients have heart muscle damage, how many need hospitalization, a ventilator to support breathing or medicine to support blood pressure in the ICU, and how many die. We will conduct the study in 15 centres in Canada and other countries.