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Preventing COVID-19 Complications With Low- and High-dose Anticoagulation (COVID-HEP)

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ClinicalTrials.gov Identifier: NCT04345848
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Blondon, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE April 7, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date December 23, 2020
Actual Study Start Date  ICMJE April 28, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality [ Time Frame: 30 days ]
Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Arterial thrombosis [ Time Frame: 30 days ]
    Risk of ischemic stroke, myocardial infarction and/or limb ischemia
  • Venous thromboembolism [ Time Frame: 30 days ]
    Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis
  • Disseminated intravascular coagulation [ Time Frame: 30 days ]
    Risk of DIC
  • All-cause mortality [ Time Frame: 30 days ]
    Risk of all-cause mortality
  • Sepsis-induced coagulopathy [ Time Frame: 30 days ]
    Risk of SIC
  • Acute respiratory distress syndrome [ Time Frame: 30 days ]
    Risk of ARDS
  • Durations of hospital stay, ICU stay, ventilation [ Time Frame: 30 days ]
    Number of days with these care processes
  • Sequential organ failure assessment score [ Time Frame: 30 days ]
    Highest score per participant
  • Clinical deterioration [ Time Frame: 30 days ]
    Risk of clinical deterioration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2020)
  • Major bleeding [ Time Frame: 30 days ]
    Risk of ISTH-defined major bleeding
  • Clinically relevant non-major bleeding [ Time Frame: 30 days ]
    Risk of ISTH-defined CRNMB
  • Heparin-induced thrombocytopenia [ Time Frame: 30 days ]
    Risk of documented HIT
  • PaO2/FiO2 index [ Time Frame: 30 days ]
    Measures of PaO2/FiO2 among participants with mechanical ventilation
Original Other Pre-specified Outcome Measures
 (submitted: April 9, 2020)
  • Major bleeding [ Time Frame: 30 days ]
    Risk of ISTH-defined major bleeding
  • Clinically relevant non-major bleeding [ Time Frame: 30 days ]
    Risk of ISTH-defined CRNMB
  • Heparin-induced thrombocytopenia [ Time Frame: 30 days ]
    Risk of documented HIT
 
Descriptive Information
Brief Title  ICMJE Preventing COVID-19 Complications With Low- and High-dose Anticoagulation
Official Title  ICMJE Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
Brief Summary

The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS.

The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • Sars-CoV2
Intervention  ICMJE Drug: Enoxaparin
Two different doses of anticoagulation
Other Name: Unfractionated heparin
Study Arms  ICMJE
  • Experimental: Therapeutic anticoagulation
    Participants will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or intravenous unfractionated heparin, from admission until the end of hospital stay or clinical recovery.
    Intervention: Drug: Enoxaparin
  • Active Comparator: Prophylactic anticoagulation
    Participants will be treated with prophylactic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or unfractionated heparin, from admission until the end of hospital stay or clinical recovery. If hospitalized in the intensive care unit, they will receive an augmented thromboprophylaxis regimen as standard of care.
    Intervention: Drug: Enoxaparin
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: adult patient with COVID-19 infections, admitted to:

  • an acute non-critical medical ward with admission D-dimer levels >1,000ng/mL, or
  • an acute critical ward (ICU, intermediate care unit)

Exclusion Criteria:

  • ongoing or planned therapeutic anticoagulation for any other indication
  • contra-indication to therapeutic anticoagulation
  • hypersensitivity to heparin
  • personal history of heparin-induced thrombocytopenia
  • suspected or confirmed bacterial endocarditis
  • bleeding events or tendency due to a suspected or confirmed hemostatic bleeding disorder
  • organic lesion prone to bleeding
  • platelet count <50G/L, Hb level <80g/L
  • ongoing or recent (<30 days) major bleeding, ischemic stroke, trauma, surgery
  • use of dual antiplatelet therapy
  • pregnancy
  • bodyweight <40kg or >150kg.
  • end of life care setting
  • unwillingness to consent
  • ongoing participation in a COVID-19 randomized clinical trial testing another therapeutic intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04345848
Other Study ID Numbers  ICMJE 2020-00794
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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: Undecided
Responsible Party Marc Blondon, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Geneva
Verification Date December 2020

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