The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations
Status:
Not yet recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans