Summary

Eligibility
for people ages up to 18 years (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Arun Panigrahi, MD (ucdavis)

Description

Summary

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).

Keywords

Infection Viral Thromboses, Venous COVID-19 Virus Diseases Thrombosis Venous Thrombosis Enoxaparin Enoxaparin Prefilled Syringe [Lovenox] Thromboprophylaxis

Eligibility

You can join if…

Open to people ages up to 18 years

  1. Birth to <18 years of age; AND
  2. Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
  3. Hospitalized, <72 hours post-admission; AND
  4. One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:
  5. Cough; OR
  6. Fever (oral temperature >100.4°F/38°C); OR
  7. Chest pain; OR
  8. Shortness of breath; OR
  9. Myalgia; OR
  10. Acute unexplained loss of smell or taste; OR
  11. New/increased supplemental oxygen requirement; OR
  12. Acute respiratory failure requiring non-invasive or invasive ventilation; OR
  13. Encephalitis.

You CAN'T join if...

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
  2. Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
  3. Platelet count <50,000/µL within the past 24 hours; OR
  4. Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
  5. Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
  6. Fibrinogen level <75 mg/dL; OR
  7. Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31 mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
  8. Parent or legally authorized representative unwilling to provide informed consent for patient participation.

Locations

  • Hemostasis and Thrombosis Center UC Davis not yet accepting patients
    Sacramento California 95817 United States
  • Rady Children's Hospital accepting new patients
    San Diego California 92123 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UC Health

  • Arun Panigrahi, MD (ucdavis)
    Associate Professor, Pediatrics. Authored (or co-authored) 5 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins All Children's Hospital
ID
NCT04354155
Phase
Phase 2
Study Type
Interventional
Last Updated