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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thromboprophylaxis | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin Prefilled Syringe [Lovenox] | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 hours post initial dose |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of In-hospital Thromboprophylaxis as Measured by the Proportion of Serial D-dimer Levels | 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. |
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:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Sochet, MD | Johns Hopkins All Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40766870 | Derived | Sochet AA, Sellers AR, Betensky M, Morrison JM, Ashour D, Fierstein JL, Amankwah EK, Bruzek S, Ignjatovic V, Goldenberg NA; COVID-19 Anticoagulation in Children-Thromboprophylaxis Trial Investigators. Immunothrombosis and plasma fibrinolytic function for pediatric COVID-19: a secondary analysis from the COVAC-TP trial. Blood Vessel Thromb Hemost. 2024 Nov 26;2(1):100038. doi: 10.1016/j.bvth.2024.100038. eCollection 2025 Feb. | |
| 35484817 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2021 | Mar 1, 2022 |
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| Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized |
| Efficacy of In-hospital Thromboprophylaxis as Measured by Number of Participants With Confirmed HA-VTE | 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. | Day 30 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Hemostasis and Thrombosis Center UC Davis | Sacramento | California | 95817 | United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Children's Hospital of Atlanta | Atlanta | Georgia | 30322 | United States |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Johns Hopkins Hospital and Children's Center | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Cohen Children's Medical Center | New Hyde Park | New York | 11040 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Children's Hospital Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Derived |
| 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. |
| 35244208 | Derived | 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
| 33502773 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline characteristics data was not collected from 1 participant that withdrew and 1 participant who did not meet criteria for study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| There were 19 < 12 years of age and 19 >/= 12 years of age. | Posted | Count of Participants | Participants | Day 30 |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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). | Analysis was done based on division of participants into two groups: < 12 years old and >/= 12 years old. | Posted | Median | Inter-Quartile Range | mg/kg | 4 hours post initial dose |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Efficacy of In-hospital Thromboprophylaxis as Measured by the Proportion of Serial D-dimer Levels | 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. | Not Posted | Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized | Participants | |||||||||||||||||||||||||||||||
| Other Pre-specified | Efficacy of In-hospital Thromboprophylaxis as Measured by Number of Participants With Confirmed HA-VTE | 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. | Posted | Count of Participants | Participants | Day 30 |
|
|
From enrollment through follow up, up to 30 days after enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 1 | 38 | 0 | 38 | 0 | 38 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Alexander Sochet | Johns Hopkins All Children's Hospital | 17277672912 | anthony.sochet@jhmi.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2021 | Mar 1, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D020246 | Venous Thrombosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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|
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