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Outpatient Liquid Aspirin (OLA) (OLA COVID)

Primary Purpose

Covid19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ASA
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lsuhsc-NoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Liquid ASA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 16, 2021
Last Updated
December 13, 2021
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Innovate Anti-Infectives
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1. Study Identification

Unique Protocol Identification Number
NCT04937088
Brief Title
Outpatient Liquid Aspirin (OLA)
Acronym
OLA COVID
Official Title
Outpatient, Liquid Aspirin to Reduce COVID-19 Hospitalizations
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
December 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Innovate Anti-Infectives

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Phase 2, proof of concept study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Soy Bean Oil identical packaging as the active arm, taken once daily by mouth for 30 days.
Arm Title
Liquid ASA
Arm Type
Active Comparator
Arm Description
Aspirin 150 mg liquid formulation (2.5%w/w) taken once daily by mouth for 30 days
Intervention Type
Drug
Intervention Name(s)
ASA
Intervention Description
Liquid aspirin formulation
Primary Outcome Measure Information:
Title
Reduced COVID-19 related hospitalizations
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Lau, MD
Phone
504-412-1240
Email
flau@lsuhsc.edu
Facility Information:
Facility Name
Lsuhsc-No
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Powell, MS
Phone
504-568-2202

12. IPD Sharing Statement

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Outpatient Liquid Aspirin (OLA)

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