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

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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Infection Viral
Thromboses, Venous
COVID-19
Intervention Drug: Enoxaparin Prefilled Syringe [Lovenox]
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Thromboprophylaxis
Hide Arm/Group 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)

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)

Period Title: Overall Study
Started 40
Completed 38
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Did not meet criteria for study intervention             1
Arm/Group Title Thromboprophylaxis
Hide Arm/Group 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)

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)

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
Baseline characteristics data was not collected from 1 participant that withdrew and 1 participant who did not meet criteria for study intervention.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
38
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Median Age (IQR) Number Analyzed 38 participants
12.1
(1.3 to 17.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
18
  47.4%
Male
20
  52.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Hispanic or Latino
12
  31.6%
Not Hispanic or Latino
25
  65.8%
Unknown or Not Reported
1
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.6%
Native Hawaiian or Other Pacific Islander
1
   2.6%
Black or African American
12
  31.6%
White
16
  42.1%
More than one race
1
   2.6%
Unknown or Not Reported
7
  18.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
 100.0%
1.Primary Outcome
Title Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
Hide 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:

  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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
There were 19 < 12 years of age and 19 >/= 12 years of age.
Arm/Group Title Thromboprophylaxis
Hide Arm/Group 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)

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)

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done based on division of participants into two groups: < 12 years old and >/= 12 years old.
Arm/Group Title Thromboprophylaxis
Hide Arm/Group 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)

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)

Overall Number of Participants Analyzed 38
Median (Inter-Quartile Range)
Unit of Measure: mg/kg
Children 12 years or older Number Analyzed 19 participants
0.5
(0.46 to 0.52)
Children less than 12 years Number Analyzed 19 participants
0.52
(0.49 to 0.55)
3.Other Pre-specified Outcome
Title Efficacy of In-hospital Thromboprophylaxis as Measured by the Proportion of Serial D-dimer Levels
Hide 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
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Efficacy of In-hospital Thromboprophylaxis as Measured by Number of Participants With Confirmed HA-VTE
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thromboprophylaxis
Hide Arm/Group 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)

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)

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.3%
Time Frame From enrollment through follow up, up to 30 days after enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thromboprophylaxis
Hide Arm/Group 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)

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)

All-Cause Mortality
Thromboprophylaxis
Affected / at Risk (%)
Total   1/38 (2.63%) 
Hide Serious Adverse Events
Thromboprophylaxis
Affected / at Risk (%)
Total   0/38 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thromboprophylaxis
Affected / at Risk (%)
Total   0/38 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anthony Alexander Sochet
Organization: Johns Hopkins All Children's Hospital
Phone: 17277672912
EMail: anthony.sochet@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT04354155    
Other Study ID Numbers: COVAC-TP
First Submitted: April 13, 2020
First Posted: April 21, 2020
Results First Submitted: March 1, 2022
Results First Posted: March 31, 2022
Last Update Posted: October 12, 2022