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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354155
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Neil Goldenberg, Johns Hopkins All Children's Hospital

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 Drug: Enoxaparin Prefilled Syringe [Lovenox] Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 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
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Safety of in-hospital thromboprophylaxis [ Time Frame: Day 30 ]
    To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence 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 [ 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 (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).


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 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 confirmed HA-VTE.

  3. Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support [ 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 median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).



Information from the National Library of Medicine

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Ages Eligible for Study:   up 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.

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


Contacts
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Contact: Frances L Hamblin, MSHS 7277672460 Frances.Hamblin@jhmi.edu
Contact: Laurel McDevitt, MS 7277676466 laurel@jhmi.edu

Locations
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United States, Florida
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Contact: Anthony Sochet, MD         
Sponsors and Collaborators
Neil Goldenberg
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Responsible Party: Neil Goldenberg, Sponsor-investigator, Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT04354155    
Other Study ID Numbers: COVAC-TP
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
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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Thrombosis
Venous Thrombosis
Virus Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action