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NCT04354155 · ClinicalTrials.gov registry record · Phase 2
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
A Phase 2 study, sponsored by Johns Hopkins All Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04354155: Completed Phase 2 study, sponsored by Johns Hopkins All Children's Hospital.
NCT04354155 is a Phase 2 study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04354155, a Phase 2 study, has completed, sponsored by Johns Hopkins All Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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).
Primary Outcome
The safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis will be measured by cumulative incidence (number of participants) of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1. fatal bleeding; 2. clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3. retroperitoneal, pulmonary, or central nervous system bleeding; 4.
Interventions
- DRUG Enoxaparin Prefilled Syringe [Lovenox]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-06-02 |
| Est. Completion | 2021-06-04 |
| Phase | Phase 2 |
What the finished NCT04354155 record still lists
NCT04354155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Enoxaparin Prefilled Syringe [Lovenox] is the first listed.
NCT04354155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04354155 about?
NCT04354155 is a clinical study titled "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).
What is the current status of trial NCT04354155?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-06-02. Estimated completion is 2021-06-04.
What interventions are being tested in trial NCT04354155?
The interventions under investigation include: Enoxaparin Prefilled Syringe [Lovenox] (DRUG).
Who is sponsoring clinical trial NCT04354155?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04354155's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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