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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354155
Recruitment Status : Completed
First Posted : April 21, 2020
Results First Posted : March 31, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins All Children's Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Infection Viral Thromboses, Venous COVID-19 Drug: Enoxaparin Prefilled Syringe [Lovenox] Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Actual Study Start Date : June 2, 2020
Actual Primary Completion Date : June 4, 2021
Actual Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Thromboprophylaxis
Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
 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)


Outcome Measures
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Primary Outcome Measures :
  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:

    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. bleeding requiring surgical intervention in an operating suite;
    5. bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition);
    6. bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Birth to <18 years of age; AND
  2. Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
  3. Hospitalized, <72 hours post-admission; AND

  4. One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:

    1. Cough; OR
    2. Fever (oral temperature >100.4°F/38°C); OR
    3. Chest pain; OR
    4. Shortness of breath; OR
    5. Myalgia; OR
    6. Acute unexplained loss of smell or taste; OR
    7. New/increased supplemental oxygen requirement; OR
    8. Acute respiratory failure requiring non-invasive or invasive ventilation; OR
    9. Encephalitis.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
  2. Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
  3. Platelet count <50,000/µL within the past 24 hours; OR
  4. Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
  5. Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
  6. Fibrinogen level <75 mg/dL; OR
  7. Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31 mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
  8. Parent or legally authorized representative unwilling to provide informed consent for patient participation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354155


Locations
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United States, Alabama
Children's of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Hemostasis and Thrombosis Center UC Davis
Sacramento, California, United States, 95817
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Florida
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Children's Hospital of Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maryland
Johns Hopkins Hospital and Children's Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New York
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
United States, Pennsylvania
Children's Hospital Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
Investigators
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Principal Investigator: Anthony Sochet, MD Johns Hopkins All Children's Hospital
  Study Documents (Full-Text)

Documents provided by Johns Hopkins All Children's Hospital:
Study Protocol  [PDF] March 8, 2021
Statistical Analysis Plan  [PDF] July 14, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT04354155    
Other Study ID Numbers: COVAC-TP
First Posted: April 21, 2020    Key Record Dates
Results First Posted: March 31, 2022
Last Update Posted: October 12, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Thrombosis
Venous Thrombosis
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action