Skip to main content
OpenTrials
Completed

NCT Number: NCT04354155

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection Viral COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thromboses, Venous Thrombosis Vascular Diseases Venous Thrombosis Virus Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

Enoxaparin Prefilled Syringe [Lovenox]

Drug

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)

Primary outcomes

  1. Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization

    Time frame: Day 30

    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:

    • fatal bleeding;
    • clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period;
    • retroperitoneal, pulmonary, or central nervous system bleeding;
    • bleeding requiring surgical intervention in an operating suite;
    • bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition);
    • bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.

Secondary outcomes

  1. Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL

    Time frame: 4 hours post initial dose

    The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4-hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (<12 and those >12 years of age).

Other outcomes

  1. Efficacy of In-hospital Thromboprophylaxis as Measured by the Proportion of Serial D-dimer Levels

    Time frame: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized

    To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.

  2. Efficacy of In-hospital Thromboprophylaxis as Measured by Number of Participants With Confirmed HA-VTE

    Time frame: Day 30

    To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by number of participants with confirmed HA-VTE.

Sponsors and collaborators

Lead sponsor

Johns Hopkins All Children's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.