Phase 2 N=40 Prevention

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

Infection Viral · Thromboses, Venous · COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT04354155 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Enoxaparin Prefilled Syringe [Lovenox] (Drug)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Johns Hopkins All Children's Hospital
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization	—	—
SECONDARY Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL	0.5; 0.52	—

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).

Eligibility Criteria

Inclusion Criteria

Birth to 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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04354155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.