Covid-19 Associated Coagulopathy

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    170
  • sponsor
    University of Iowa
Updated on 24 January 2021

Summary

This prospective, randomized, open-label, multi-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score 3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).

Description

Potentially eligible patients will be identified by a healthcare professional per institutional policy on privacy. The healthcare professional will assess the eligibility of the patient by performing a chart review which will include laboratory results and weight as measured on admission to the hospital. After obtaining verbal consent from the patient to be contacted for the study, a member of the research staff will approach the patient to be part of the study. The research staff will obtain informed consent from the patient/LAR before collecting any data and performing any procedures.

5.2 Trial interventions

As standard of care, hospitalized patients with confirmed COVID-19 will be monitored for coagulopathy. Daily blood tests for platelet count, prothrombin time, D-Dimer, and fibrinogen and weekly thromboelastography will be obtained, and a daily Modified ISTH Overt DIC score will be calculated (Exhibit 1). Only patients meeting all inclusion and exclusion criteria will be asked to participate in the trial. Patients will be randomized to one of two arms:

  1. Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI <30 kg/m2; 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI 30 kg/m2).
  2. Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI <30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI 30 kg/m2), with doses rounded up to the nearest dose syringe in hospitalized patients with laboratory confirmed SARS CoV-2 infection.

5.3 Dose Modifications

  1. Enoxaparin will be held if platelets decrease to <25,000/mm3. Enoxaparin will resume once platelets increase to 25,000/ mm3.
  2. Enoxaparin will be held if fibrinogen is <50 mg/dL. Enoxaparin will resume once fibrinogen increases to 50 mg/dL.
  3. Enoxaparin will be held if estimated Creatinine clearance < 15 ml/min calculated by the modified Cockcroft and Gault formula and resumed once the Creatinine Clearance is 15 ml/min.
  4. Enoxaparin will be held if there is a clinical suspicion for heparin induced thrombocytopenia.
  5. Enoxaparin dose will be reduced by 25% if Creatinine Clearance 15 and <30 ml/min calculated by the modified Cockcroft and Gault formula and increased once the estimated Creatinine Clearance is 30 ml/min in both the arms.

All participating patients will continue the assigned doses of enoxaparin until hospital discharge or until a clinical event occurs requiring either discontinuation of anticoagulation therapy or full therapeutic dose anticoagulation therapy.

Details
Condition COVID 19 Associated Coagulopathy
Treatment Intermediate dose thromboprophylaxis, Standard of Care thromboprophylaxis
Clinical Study IdentifierNCT04360824
SponsorUniversity of Iowa
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have COVID 19 Associated Coagulopathy?
Do you have any of these conditions: Do you have COVID 19 Associated Coagulopathy??
Laboratory confirmed SARS-CoV-2 infection
Age 18 years
Requires hospital admission for further clinical management
Modified ISTH Overt DIC score 3

Exclusion Criteria

Indication for full therapeutic-dose anticoagulation
Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months
Acute cardiovascular event within prior 3 months
Acute stroke (ischemic or hemorrhagic) within prior 3 months
Active major bleeding
Severe thrombocytopenia (<25,000/mm3)
Increased risk of bleeding, as assessed by the investigator
Acute or chronic renal insufficiency with Creatinine Clearance < 30 ml/min calculated by the modified Cockcroft and Gault formula
Weight < 40 kg
Known allergies to ingredients contained in enoxaparin, allergy to heparin products or history of heparin induced thrombocytopenia
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