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

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ClinicalTrials.gov Identifier: NCT04354155
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins All Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 13, 2020
First Posted Date  ICMJE April 21, 2020
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE June 2, 2020
Actual Primary Completion Date June 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
Safety of in-hospital thromboprophylaxis [ Time Frame: Day 30 ]
To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
Median twice-daily enoxaparin dose [ Time Frame: 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 (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2020)
  • Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels [ Time Frame: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized ]
    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.
  • Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE [ Time Frame: Day 30 ]
    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 confirmed HA-VTE.
  • Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support [ Time Frame: Day 30 ]
    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 median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Official Title  ICMJE COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Infection Viral
  • Thromboses, Venous
  • COVID-19
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: 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)
Intervention: Drug: Enoxaparin Prefilled Syringe [Lovenox]
Publications * Flumignan RL, Tinôco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah ÁN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10:CD013739. doi: 10.1002/14651858.CD013739.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2021)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2020)
38
Actual Study Completion Date  ICMJE June 4, 2021
Actual Primary Completion Date June 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04354155
Other Study ID Numbers  ICMJE COVAC-TP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins All Children's Hospital
Study Sponsor  ICMJE Johns Hopkins All Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony Sochet, MD Johns Hopkins All Children's Hospital
PRS Account Johns Hopkins All Children's Hospital
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP