LSU Health New Orleans is recruiting up to 200 participants recently diagnosed with COVID-19 to a proof-of-concept clinical trial to test whether early outpatient treatment with liquid aspirin can reduce hospitalization rates. This liquid aspirin formulation is currently not FDA-approved in the United States.
Frank Lau, MD, associate professor of surgery at LSU Health New Orleans School of Medicine, is the principal investigator. Supported by UK-based Innovate Anti-infectives Ltd., it uses enhanced liquid aspirin (ELA), a drug formulated by Innovate Anti-infectives Ltd., led by Medical Director Jimmy Stuart and CEO Simon Cohen.
Although COVID-19 is classified as an acute respiratory infection, COVID-associated coagulopathy (CAC) has been linked to death and severe illness. This condition can cause abnormalities of blood flow, including the tendency toward prolonged or excessive clotting. Anticoagulant therapies such as heparin have been shown to reduce CAC-related mortality and are now standard of care for hospitalized COVID-19 patients. However, no data regarding outpatient management of COVID-19 with anticoagulant therapies have been published.
The trial is a randomized, double-blind placebo control study. Participants will be randomly assigned to one of two study arms. Participants in Arm 1 will receive a placebo, which is an inactive substance of soybean oil. Participants assigned to Arm 2 will receive 150 mg of liquid aspirin daily.
As with any study, there are risks, including allergic reactions to study drugs. Although conventional aspirin is an over-the-counter medication that is routinely taken by patients who are at risk for cardiovascular events, some side effects have been noted. Possible side effects include nausea, upset stomach, heartburn, gastritis, gastric bleeding, soft tissue bleeding, or bruising. Participants could also experience intolerance and allergic reaction to the soybean oil in the placebo. Patients with preexisting risk factors of bleeding will be excluded from the study.
If the study’s hypothesis is correct, subjects who receive the treatments may benefit through reduced disease severity and reduced chances of hospitalization, although no direct medical benefit can be guaranteed. Study results may lead to a low-risk and early outpatient treatment method to reduce the hospitalization rate for newly diagnosed COVID-19 patients. This study will also help the researchers learn more about how liquid aspirin and serum vitamin D levels can affect COVID-19 disease severity and hospitalizations. This information may help in the treatment of future patients with COVID-19.
“COVID-19 has affected millions of people world-wide,” said Stuart. “The available vaccines have proven to be effective against COVID-19, but with some limitations. In particular, the protection they give seems to decline after six months. While vaccines will continue to be the main defense against COVID, we also need to develop medications that are effective in treating this disease.”
For more information, contact Catherine Powell at 504-568-2202.