NCT04937088

Outpatient Liquid Aspirin (OLA)

Outpatient, Liquid Aspirin to Reduce COVID-19 Hospitalizations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

200 people will take part in this LSUHSC-NO and its affiliates study. The clinical site will offer study enrollment to newly diagnosed COVID-19 patients at the time of diagnosis. Contact information will be shared with study team in a HIPAA compliant manner on the same day. Within 24 hours, our Study staff will contact patient for recruitment and enrollment. Within 48 hours of enrollment, the patient will come to a study site for randomization to treatment arms, to be provided a no-cost supply of the treatment which they are assigned, and for blood draws that help determine their risk of developing severe COVID disease. Patients will be assigned to either: Arm 1: Placebo Or Arm 2: Treatment with liquid aspirin 150 mg daily. (ASA 150). Study staff will follow-up every 2 days for a total of 30 days by text/phone/telemedicine to monitor changes in their health status, hospitalization rates, and encourage adherence to the treatment arm. Between days 7 and 10 of the study, patients will undergo repeat blood draws to help ensure their safety with regards to COVID-19. If they become hospitalized due to COVID-19, their participation will extend until they are discharged from the hospital. Medical records will be reviewed to collect data including demographics, medical comorbidities, laboratory data and hospitalization course. After 30 days of treatment, weekly follow up for another 30 days will take place ensure no late, adverse events occurred.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	ASA	Liquid aspirin formulation

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2021-06-23
• Last updated: 2022-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study