Outpatient Liquid Aspirin (OLA)

NCT04937088 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 1658
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduced COVID-19 related hospitalizations

  To obtain reliable and interpretable data to inform future trials regarding our hypothesis that a 30 day treatment course of COVID patients with a novel, liquid aspirin formulation can reduce hospitalizations driven by COVID associate coagulopathy (CAC)

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: ASA

Liquid ASA

ACTIVE COMPARATOR

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

Drug: ASA

Interventions

ASA DRUG

Liquid aspirin formulation

Liquid ASA; Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Innovate Anti-Infectives: collaborator

Study Sites (1)

Lsuhsc-No

New Orleans, Louisiana, 70112, United States

RECRUITING

Related Publications (1)

• Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.

  PMID: 37489818 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Frank Lau, MD

CONTACT

504-412-1240; flau@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo and ASA 150 will be labeled to maintain blinding. The Principal Investigator and one Biostatistician will remain blinded to prevent any bias. Study staff/healthcare providers distributing the treatments to study subjects will be blinded to treatment assignment. Subjects will also be blinded to their treatment assignment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 2, proof of concept study

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 23, 2021
• Study Start: December 6, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

US (1)