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

NCT04354155 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: COVAC-TP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 16

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).

Conditions

Infection Viral; Thromboses, Venous; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Day 30

Secondary Outcomes (1)

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

  4 hours post initial dose

Other Outcomes (2)

• Efficacy of In-hospital Thromboprophylaxis as Measured by the Proportion of Serial D-dimer Levels

  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

  Day 30

Study Arms (1)

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)

Drug: Enoxaparin Prefilled Syringe [Lovenox]

Interventions

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)

Thromboprophylaxis

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (16)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Hemostasis and Thrombosis Center UC Davis

Sacramento, California, 95817, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Children's Hospital of Atlanta

Atlanta, Georgia, 30322, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Johns Hopkins Hospital and Children's Center

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Children's Hospital Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (4)

• 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.

  PMID: 40766870 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.

  PMID: 35484817 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. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

  PMID: 35244208 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.

  PMID: 33502773 DERIVED

MeSH Terms

Conditions

Virus Diseases; Venous Thrombosis; COVID-19

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Infections; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Anthony Alexander Sochet
• Organization: Johns Hopkins All Children's Hospital

anthony.sochet@jhmi.edu

17277672912

Study Officials

• Anthony Sochet, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 21, 2020
• Study Start: June 2, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: October 12, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)