COVID-19 Clinical Trial
Official title:
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
NCT number | NCT04354155 |
Other study ID # | COVAC-TP |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2, 2020 |
Est. completion date | June 4, 2021 |
Verified date | March 2022 |
Source | Johns Hopkins All Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins All Children's Hospital |
United States,
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 |
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