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

Primary Purpose

COVID, Sars-CoV2

Status
Terminated
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID focused on measuring anticoagulation, heparin, thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva University Hospitals
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Ospedale Regionale di Locarno
  • Hôpital du Valais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic anticoagulation

Prophylactic anticoagulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality

Secondary Outcome Measures

Arterial thrombosis
Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Venous thromboembolism
Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis
Disseminated intravascular coagulation
Risk of DIC
All-cause mortality
Risk of all-cause mortality
Sepsis-induced coagulopathy
Risk of SIC
Acute respiratory distress syndrome
Risk of ARDS
Durations of hospital stay, ICU stay, ventilation
Number of days with these care processes
Sequential organ failure assessment score
Highest score per participant
Clinical deterioration
Risk of clinical deterioration

Full Information

First Posted
April 7, 2020
Last Updated
September 7, 2021
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04345848
Brief Title
Preventing COVID-19 Complications With Low- and High-dose Anticoagulation
Acronym
COVID-HEP
Official Title
Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Low recruitement
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Sars-CoV2
Keywords
anticoagulation, heparin, thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic anticoagulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Prophylactic anticoagulation
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Unfractionated heparin
Intervention Description
Two different doses of anticoagulation
Primary Outcome Measure Information:
Title
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Description
Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Arterial thrombosis
Description
Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Time Frame
30 days
Title
Venous thromboembolism
Description
Risk of symptomatic venous thromboembolism or asymptomatic proximal leg deep vein thrombosis
Time Frame
30 days
Title
Disseminated intravascular coagulation
Description
Risk of DIC
Time Frame
30 days
Title
All-cause mortality
Description
Risk of all-cause mortality
Time Frame
30 days
Title
Sepsis-induced coagulopathy
Description
Risk of SIC
Time Frame
30 days
Title
Acute respiratory distress syndrome
Description
Risk of ARDS
Time Frame
30 days
Title
Durations of hospital stay, ICU stay, ventilation
Description
Number of days with these care processes
Time Frame
30 days
Title
Sequential organ failure assessment score
Description
Highest score per participant
Time Frame
30 days
Title
Clinical deterioration
Description
Risk of clinical deterioration
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Major bleeding
Description
Risk of ISTH-defined major bleeding
Time Frame
30 days
Title
Clinically relevant non-major bleeding
Description
Risk of ISTH-defined CRNMB
Time Frame
30 days
Title
Heparin-induced thrombocytopenia
Description
Risk of documented HIT
Time Frame
30 days
Title
PaO2/FiO2 index
Description
Measures of PaO2/FiO2 among participants with mechanical ventilation
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
Country
Switzerland
Facility Name
Ospedale Regionale di Locarno
City
Locarno
Country
Switzerland
Facility Name
Hôpital du Valais
City
Sion
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35244208
Citation
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
Results Reference
derived
PubMed Identifier
33502773
Citation
Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
Results Reference
derived
PubMed Identifier
32407672
Citation
Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
Results Reference
derived

Learn more about this trial

Preventing COVID-19 Complications With Low- and High-dose Anticoagulation

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