NCT04937088.

Study name	Outpatient Liquid Aspirin (OLA)
Methods	Trial design: randomised single‐group assignment Type of publication: trial registry Setting: outpatient Recruitment dates: recruiting Country: USA Language: English Number of centres: single‐centre Inclusion criteria: > 40 years, written informed consent, within 24 hours of COVID‐19 diagnosis, serum 250HD levels drawn at time of COVID‐19 laboratory workup Exclusion criteria: asymptomatic patients, patients already taking ASA and other anticoagulant/antiplatelet therapies including but not limited to clopidogrel, heparin, low molecular weight heparin, coumadin, apixaban, pregnant patients, 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, anaemia at time of COVID diagnosis (defined as haemoglobin level < 12 g/dL in women), history of chronic kidney disease, concurrent use of nonsteroid anti‐inflammatory drugs or steroids, hypervitaminosis F and associated risk factors: renal failure, liver failure, hyperparathyroidism, sarcoidosis, histoplasmosis; known allergy to aspirin, inability to tolerate oral medications, known history of aspirin‐included asthma, history of bleeding problems, patients who cannot avoid drinking 3 or more alcoholic drinks every day during 30‐day course of ASA treatment, patients who cannot stop taking other nonprescription NSAIDs during 30‐day course of ASA treatment, patients requiring hospitalisation (for any reason) at time of screening, patients taking or who plan to take on an outpatient basis remdesivir, dexamethasone, or other therapies for treatment of COVID Trial registration number: NCT04937088 Date of trial registration: 16 June 2021 Prospective completion date: 30 June 2022
Participants	Age: > 40 years Gender: female/male Ethnicity: NR Number of participants (recruited/allocated/evaluated): 200/NR/NR Severity of disease: SARS‐CoV‐2 infection (COVID‐19) Additional diagnosis: NR Previous treatment: NR
Interventions	Aspirin 150 mg liquid formulation (2.5% w/w) taken once daily by mouth for 30 days Placebo: soy bean oil, identical packaging as the active arm, taken once daily by mouth for 30 days Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: NR Compliance with assigned treatment: NR
Outcomes	Primary outcomes Reduced COVID‐19 related hospitalisations at 6 months Secondary outcomes: NR Additional outcomes: NR
Starting date	6 December 2021
Contact information	Frank Lau, MD 504‐412‐1240, flau@lsuhsc.edu
Notes	Louisiana State University Health Sciences Center in New Orleans, Innovate UK