Recruiting
Phase 2

Aspirin

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT04937088

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

ASA

Study Details

Brief 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.

Conditions

Covid19

Study ID

NCT04937088

Start date

Dec 6, 2021

Status verified date

Dec, 2021

Completion date

Dec 5, 2022

Anticipated

Primary completion date

Dec 5, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Soy Bean Oil identical packaging as the active arm, taken once daily by mouth for 30 days.

active comparator: Liquid ASA

Aspirin 150 mg liquid formulation (2.5%w/w) taken once daily by mouth for 30 days

Interventions

ASA

Liquid aspirin formulation

Primary outcome measure

  • Reduced COVID-19 related hospitalizations [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Frank Lau, MD

504-412-1240flau@lsuhsc.edu

Locations

Lsuhsc-No

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Catherine Powell, MS

504-568-2202

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Jan 3, 2022

Last verified

Dec, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2022-01-03.