Status:
COMPLETED
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Lead Sponsor:
Johns Hopkins All Children's Hospital
Conditions:
Infection Viral
Thromboses, Venous
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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 y...
Eligibility Criteria
Inclusion
- Birth to \<18 years of age; AND
- Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
- Hospitalized, \<72 hours post-admission; AND
- One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:
- Cough; OR
- Fever (oral temperature \>100.4°F/38°C); OR
- Chest pain; OR
- Shortness of breath; OR
- Myalgia; OR
- Acute unexplained loss of smell or taste; OR
- New/increased supplemental oxygen requirement; OR
- Acute respiratory failure requiring non-invasive or invasive ventilation; OR
- Encephalitis.
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
- Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
- Platelet count \<50,000/µL within the past 24 hours; OR
- Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
- Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
- Fibrinogen level \<75 mg/dL; OR
- Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) \<31 mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
- Parent or legally authorized representative unwilling to provide informed consent for patient participation.
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04354155
Start Date
June 2 2020
End Date
June 4 2021
Last Update
October 12 2022
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Hemostasis and Thrombosis Center UC Davis
Sacramento, California, United States, 95817
4
Rady Children's Hospital
San Diego, California, United States, 92123