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

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.