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The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations (LEAD COVID-19)

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ClinicalTrials.gov Identifier: NCT04363840
Recruitment Status : Not yet recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Louisiana State University Health Sciences Center in New Orleans

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.


Condition or disease Intervention/treatment Phase
COVID Vitamin D Deficiency Coagulopathy Disseminated Intravascular Coagulation Drug: Aspirin 81 mg Dietary Supplement: Vitamin D Phase 2

Detailed Description:

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. Data from Wuhan showed that COVID-19-associated coagulopathy (CAC) was present in 71% of deaths vs. 0.4% of survivors. 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 high prevalence of CAC in severely ill COVID-19 patients led the American Society of Hematology to recommend that all hospitalized COVID-19 patients be prophylactically anticoagulated. However, there are no data and no recommendations regarding outpatient prevention of CAC.

The pathogenesis of CAC is unknown. Given the demographic, geographic, pathologic, and treatment overlap between severe COVID-19 and vitamin D insufficiency (VDI), we hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from critically ill COVID-19 patients in New Orleans support this hypothesis. Furthermore, mouse models of VDI developed aggravated multiorgan thrombus formation after lipopolysaccharide injection; this phenotype parallels CAC.

Given these lines of evidence, 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 (The LEAD COVID-19 Trial) can mitigate the prothrombotic state and reduce hospitalization rates.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The LEAD COVID-19 Trial: Low-risk, Early Aspirin and Vitamin D to Reduce COVID-19 Hospitalizations
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
No Intervention: Observation
Experimental: Aspirin 81 mg Drug: Aspirin 81 mg
Aspirin 81 mg to be taken orally once daily for 14 days.

Experimental: Aspirin + vitamin D
Offered to COVID-19 patients who are vitamin D deficient AND randomized to aspirin
Drug: Aspirin 81 mg
Aspirin 81 mg to be taken orally once daily for 14 days.

Dietary Supplement: Vitamin D
Vitamin D 50,000 IU to be taken orally once weekly for 2 weeks




Primary Outcome Measures :
  1. Hospitalization [ Time Frame: 2 weeks ]
    Hospitalization for COVID-19 symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years
  • Written informed consent
  • New (within 24 hours) COVID-19 diagnosis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363840


Contacts
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Contact: Frank H Lau, MD 504 412 1240 flau@lsuhsc.edu

Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Frank H Lau, MD LSUHSC-NO
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Responsible Party: Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT04363840    
Other Study ID Numbers: 20-063
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Disseminated Intravascular Coagulation
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Aspirin
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors