Study Stopped
lack of funding
The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations
LEAD COVID-19
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2020
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedDecember 27, 2021
December 1, 2021
7 months
April 24, 2020
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hospitalization
Hospitalization for COVID-19 symptoms
2 weeks
Study Arms (3)
Observation
NO INTERVENTIONAspirin 81 mg
EXPERIMENTALAspirin + vitamin D
EXPERIMENTALOffered to COVID-19 patients who are vitamin D deficient AND randomized to aspirin
Interventions
Aspirin 81 mg to be taken orally once daily for 14 days.
Vitamin D 50,000 IU to be taken orally once weekly for 2 weeks
Eligibility Criteria
You may qualify if:
- Patients \> 18 years
- Written informed consent
- New (within 24 hours) COVID-19 diagnosis
You may not qualify if:
- Pregnant patients or Prisoners
- History of GI bleeding or peptic ulcer disease, or spontaneous bleeding from other sites; History of thrombocytopenia; 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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: 37489818DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank H Lau, MD
LSUHSC-NO
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2020
First Posted
April 27, 2020
Study Start
May 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
December 27, 2021
Record last verified: 2021-12