OLA COVID: Outpatient Liquid Aspirin (OLA)

Sponsor

Louisiana State University Health Sciences Center in New Orleans (Other)

Overall Status

Recruiting

CT.gov ID

NCT04937088

Collaborator

Innovate Anti-Infectives (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: ASA	Phase 2

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Phase 2, proof of concept studyPhase 2, proof of concept study

Masking:

Triple (Participant, Investigator, Outcomes 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.

Primary Purpose:

Other

Official Title:

Outpatient, Liquid Aspirin to Reduce COVID-19 Hospitalizations

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Dec 5, 2022

Anticipated Study Completion Date :

Dec 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Soy Bean Oil identical packaging as the active arm, taken once daily by mouth for 30 days.	Drug: ASA Liquid aspirin formulation
Active Comparator: Liquid ASA Aspirin 150 mg liquid formulation (2.5%w/w) taken once daily by mouth for 30 days	Drug: ASA Liquid aspirin formulation

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: ASA

Liquid aspirin formulation

Active Comparator: Liquid ASA

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

Drug: ASA

Liquid aspirin formulation

Outcome Measures

Primary Outcome Measures

Reduced COVID-19 related hospitalizations [6 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lsuhsc-No	New Orleans	Louisiana	United States	70112

Sponsors and Collaborators

Louisiana State University Health Sciences Center in New Orleans
Innovate Anti-Infectives

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Louisiana State University Health Sciences Center in New Orleans

ClinicalTrials.gov Identifier:

NCT04937088

Other Study ID Numbers:

1658

First Posted:

Jun 23, 2021

Last Update Posted:

Jan 3, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 3, 2022