COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial

COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial

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).

Inclusion Criteria:

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:

   1. Cough; OR
   2. Fever (oral temperature >100.4°F/38°C); OR
   3. Chest pain; OR
   4. Shortness of breath; OR
   5. Myalgia; OR
   6. Acute unexplained loss of smell or taste; OR
   7. New/increased supplemental oxygen requirement; OR
   8. Acute respiratory failure requiring non-invasive or invasive ventilation; OR
   9. Encephalitis.

Exclusion Criteria:

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.