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Trial - NCT04937088


Column Value
Trial registration number NCT04937088
Full text link
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04937088

First author
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Frank Lau, MD

Contact
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

flau@lsuhsc.edu

Registration date
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

2021-06-23

Recruitment status
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

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
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Louisiana State University Health Sciences Center in New Orleans

Inclusion age min
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

40

Inclusion age max
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 5, 2022, 7 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Reduced COVID-19 related hospitalizations

Notes
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 735, "treatment_name": "Liquid aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]