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

Primary Purpose

Infection Viral, Thromboses, Venous, COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin Prefilled Syringe [Lovenox]
Sponsored by
Johns Hopkins All Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection Viral

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's of Alabama
  • Children's Hospital Los Angeles
  • Hemostasis and Thrombosis Center UC Davis
  • Rady Children's Hospital
  • Johns Hopkins All Children's Hospital
  • Children's Hospital of Atlanta
  • Lurie Children's Hospital
  • Rush University Medical Center
  • Children's Hospital New Orleans
  • Johns Hopkins Hospital and Children's Center
  • Boston Children's Hospital
  • Children's Hospital of Michigan
  • Cohen Children's Medical Center
  • Akron Children's Hospital
  • Children's Hospital Pittsburgh
  • Children's Medical Center of Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thromboprophylaxis

Arm Description

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)

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
April 13, 2020
Last Updated
September 15, 2022
Sponsor
Johns Hopkins All Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04354155
Brief Title
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Official Title
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Viral, Thromboses, Venous, COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thromboprophylaxis
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Prefilled Syringe [Lovenox]
Intervention Description
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 Measure Information:
Title
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL
Description
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).
Time Frame
4 hours post initial dose
Other Pre-specified Outcome Measures:
Title
Efficacy of In-hospital Thromboprophylaxis as Measured by the Proportion of Serial D-dimer Levels
Description
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.
Time Frame
Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized
Title
Efficacy of In-hospital Thromboprophylaxis as Measured by Number of Participants With Confirmed HA-VTE
Description
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.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Sochet, MD
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Hemostasis and Thrombosis Center UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Johns Hopkins Hospital and Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Children's Hospital Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Children's Medical Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35484817
Citation
Sochet AA, Morrison JM, Jaffray J, Godiwala N, Wilson HP, Thornburg CD, Bhat RV, Zia A, Lawrence C, Kudchadkar SR, Hamblin F, Russell CJ, Streiff MB, Spyropoulos AC, Amankwah EK, Goldenberg NA; COVID-19 Anticoagulation in Children - Thromboprophylaxis (COVAC-TP) Trial Investigators. Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial. Pediatrics. 2022 Jul 1;150(1):e2022056726. doi: 10.1542/peds.2022-056726.
Results Reference
derived
PubMed Identifier
35244208
Citation
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
Results Reference
derived
PubMed Identifier
33502773
Citation
Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
Results Reference
derived

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

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