Trial Outcomes & Findings for COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial (NCT NCT04354155)

Last Updated: 2022-10-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Day 30

Results posted on

2022-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	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) 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 Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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) 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 Study Withdrawal by Subject	1
Overall Study Did not meet criteria for study intervention	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thromboprophylaxis n=38 Participants 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)
Age, Categorical <=18 years	38 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous Median Age (IQR)	12.1 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: There were 19 \< 12 years of age and 19 \>/= 12 years of age.

Outcome measures

Outcome measures
Measure	Thromboprophylaxis n=38 Participants 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)
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization	0 Participants

SECONDARY outcome

Timeframe: 4 hours post initial dose

Population: Analysis was done based on division of participants into two groups: \< 12 years old and \>/= 12 years old.

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).

Outcome measures

Outcome measures
Measure	Thromboprophylaxis n=38 Participants 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)
Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL Children 12 years or older	0.5 mg/kg Interval 0.46 to 0.52
Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL Children less than 12 years	0.52 mg/kg Interval 0.49 to 0.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thromboprophylaxis n=38 Participants 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)
Efficacy of In-hospital Thromboprophylaxis as Measured by Number of Participants With Confirmed HA-VTE	2 Participants

Adverse Events

Thromboprophylaxis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Alexander Sochet

Johns Hopkins All Children's Hospital

Phone: 17277672912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place