Outpatient Liquid Aspirin (OLA)

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to obtain reliable and interpretable data to inform future trials regarding our hypothesis that a novel, liquid aspirin formulation can mitigate COVID -19 associated coagulopathy (CAC) . The potential impact is to reduce COVID-19 related hospitalization within 30 days of diagnosis due to (1) pulmonary events including respiratory failure; (2) cardiac events including myocardial infarction and myocarditis (3) venous or arterial thrombotic events; (4) acute renal insufficiency or failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborator: Innovate UK

Criteria

Inclusion Criteria:

• Patients > 40 years

• Written informed consent

• New (within 24 hours) COVID-19 diagnosis

• Serum 25OHD levels drawn at time of COVID-19 laboratory workup

Exclusion Criteria:

• Asymptomatic patients

• Patients already taking ASA and other anti-coagulant / anti-platelet therapies including but not limited to clopidogrel, heparin, low molecular weight heparin, coumadin, apixaban.

• Pregnant patients or prisoners

• History of GI bleeding or peptic ulcer disease, or spontaneous bleeding from other sites

• Thrombocytopenia (platelets <130,000/uL) at time of COVID diagnosis

• Anemia at time of COVID diagnosis (defined as hemoglobin level <12 g/dl in men or <11 g/dl in women)22

• History of chronic kidney disease

• Concurrent use of nonsteroidal anti-inflammatory drugs, or steroids

• Hypervitaminosis D and associated risk factors: Renal failure, Liver failure, Hyperparathyroidism, Sarcoidosis, Histoplasmosis

• Known allergy to Aspirin

• Inability to tolerate oral medications

• Known history of aspirin-induced asthma

• History of bleeding problems

• Patients who cannot avoid drinking 3 or more alcoholic drinks every day during the 30-day course of ASA treatment

• Patients who cannot stop taking other nonprescription NSAIDs (ibuprofen, naproxen, or others) during the 30-day course of ASA treatment

• Patients requiring hospitalization (for any reason) at time of screening

• Patients taking or who plan to take on an outpatient basis remdisivir, dexamethasone, or other therapies for treatment of COVID