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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-28

Study Completion Date

2021-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID Sars-CoV2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

Two different doses of anticoagulation

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.

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Two different doses of anticoagulation

Interventions

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Enoxaparin

Two different doses of anticoagulation

Intervention Type DRUG

Other Intervention Names

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Unfractionated heparin

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No