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

Phase 2

Completed

• Conditions: Infection Viral; Thromboses, Venous; COVID-19
• Interventions: Drug: Enoxaparin Prefilled Syringe [Lovenox]

• Registration Number: NCT04354155
• Lead Sponsor: Johns Hopkins All Children's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2020-06-02
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2022-03
• Results First Submitted: 2022-03-01
• Results First Submitted QC: 2022-03-28
• Results First Posted: 2022-03-31
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thromboprophylaxis	Enoxaparin Prefilled Syringe [Lovenox]	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)

Primary Outcome Measures

Name	Time	Method
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization	Day 30	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.

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (16)

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins Hospital and Children's Center; 🇺🇸 Baltimore, Maryland, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Children's Hospital Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Johns Hopkins All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Children's Hospital of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cohen Children's Medical Center; 🇺🇸 New Hyde Park, New York, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Hemostasis and Thrombosis Center UC Davis; 🇺🇸 Sacramento, California, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

Children's Hospital New Orleans; 🇺🇸 New Orleans, Louisiana, United States