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

Completed · Phase 2

Conditions studied: Infection Viral, Thromboses, Venous, COVID-19

In brief

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).

Key facts

Study ID

NCT04354155

Run by

Johns Hopkins All Children's Hospital

People needed

40

Starts

2020-06-02

Expected to finish

2021-06-04

Last updated by the study team

2022-10-12

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Hemostasis and Thrombosis Center UC Davis — Sacramento, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Hospital of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Children's Hospital New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins Hospital and Children's Center — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Cohen Children's Medical Center — New Hyde Park, New York, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Children's Hospital Pittsburgh — Pittsburgh, Pennsylvania, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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