COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
NCT ID: NCT04354155
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2020-06-02
2021-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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.
0 Years
18 Years
ALL
No
Sponsors
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Johns Hopkins All Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Anthony Sochet, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins All Children's Hospital
Locations
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Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Hemostasis and Thrombosis Center UC Davis
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Children's Hospital of Atlanta
Atlanta, Georgia, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Johns Hopkins Hospital and Children's Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Children's Hospital Pittsburgh
Pittsburgh, Pennsylvania, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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COVAC-TP
Identifier Type: -
Identifier Source: org_study_id
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