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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354155
• Other study ID #: COVAC-TP
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: March 2022
• Source: Johns Hopkins All Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Birth to <18 years of age; AND

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:

An individual who meets any of the following criteria will be excluded from participation in this study:

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.

Related Conditions & MeSH terms

• COVID-19
• Infection Viral
• Thromboses, Venous
• Thrombosis
• Venous Thrombosis
• Virus Diseases

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	Children's Hospital of Atlanta	Atlanta	Georgia
United States	Johns Hopkins Hospital and Children's Center	Baltimore	Maryland
United States	Children's of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Cohen Children's Medical Center	New Hyde Park	New York
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Children's Hospital Pittsburgh	Pittsburgh	Pennsylvania
United States	Hemostasis and Thrombosis Center UC Davis	Sacramento	California
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins All Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized
Other	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
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: fatal bleeding; clinically overt bleeding associated with a decline in hemoglobin of =2g/dL in a 24h period; retroperitoneal, pulmonary, or central nervous system bleeding; bleeding requiring surgical intervention in an operating suite; bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.	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).	4 hours post initial dose