NCT04363840.

Study name	The LEAD COVID‐19 Trial: Low‐risk, Early aspirin and Vitamin D to Reduce COVID‐19 Hospitalizations (LEAD COVID‐19)
Methods	Trial design: randomised clinical trial, open‐label, phase 2 Type of publication: trial registry Setting: hospital Recruitment dates: terminated Country: USA Language: English Number of centres: NR Inclusion criteria: patients > 18 years, written informed consent Exclusion criteria: 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, new (within 24 hours) COVID‐19 diagnosis Trial registration number: NCT04363840 Date of trial registration: 27 April 2020 Prospective completion date: December 2020
Participants	Age: > 18 years Gender: NR Ethnicity: NR Number of participants (recruited/allocated/evaluated): 1080/NR/NR Severity of disease: SARS‐CoV‐2 infection (COVID‐19) Additional diagnoses: vitamin D deficiency, coagulopathy, disseminated intravascular coagulation Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR
Interventions	Aspirin 81 mg to be taken orally once daily for 14 days Aspirin 81 mg to be taken orally once daily for 14 days + dietary supplement: vitamin D 50,000 IU to be taken orally once weekly for 2 weeks Control: observation Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: NR Treatment cross‐overs: NR Compliance with assigned treatment: NR
Outcomes	Primary outcomes: hospitalisation Secondary outcomes: NR Additional outcomes: NR
Starting date	1 May 2020
Contact information	Contact: Frank H Lau, MD 504 412 1240, flau@lsuhsc.edu
Notes	Due to missing funding the trial was not started Sponsor/funding: Louisiana State University Health Sciences Center in New Orleans COIs: NR Other: NR