Trials / Completed
CompletedNCT04354155
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Johns Hopkins All Children's Hospital · Academic / Other
- Sex
- All
- Age
- 0 Years – 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enoxaparin Prefilled Syringe [Lovenox] | Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL) |
Timeline
- Start date
- 2020-06-02
- Primary completion
- 2021-06-04
- Completion
- 2021-06-04
- First posted
- 2020-04-21
- Last updated
- 2022-10-12
- Results posted
- 2022-03-31
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04354155. Inclusion in this directory is not an endorsement.