Outpatient Liquid Aspirin (OLA)

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04937088

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

200

Starts

2021-12-06

Expected to finish

2022-12-05

Last updated by the study team

2022-01-03

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 40 years
• Written informed consent
• New (within 24 hours) COVID-19 diagnosis
• Serum 25OHD levels drawn at time of COVID-19 laboratory workup

You may not qualify if…

• 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

Where it is running

• Lsuhsc-No — New Orleans, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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