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Completed

NCT Number: NCT04409834

Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial

The researchers wanted to learn how to help sick patients who are in the hospital because of COVID-19. They are trying to find out the best way that is safe to stop blood clots that could be dangerous from forming in patients with COVID-19. This research study happened at 34 hospitals.

All patients in the study took medicines that help prevent blood clots. These medicines are called blood thinners or anticoagulants. Patients got different amounts of blood thinners to see what works better and is safer. Researchers randomly chose some patients to get more and some to get less.

The researchers also wanted to know if another medicine called clopidogrel can safely help stop blood clots from forming. This kind of medicine helps keep parts of the blood, called platelets, from sticking together. In some patients who did not have other reasons to take a platelet-blocker the researchers randomly chose the patient to take clopidogrel or not. This type of medicine is also called an antiplatelet.

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Key information

Conditions

COVID-19 Arterial Thrombosis Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thromboembolism Vascular Diseases Venous Thromboembolism Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02459, United States

About this study

This is a multicenter, open-label, randomized-controlled trial in critically-ill patients with novel coronavirus disease 2019 (COVID-19) evaluating the efficacy and safety of full-dose vs. standard prophylactic dose anticoagulation and of antiplatelet vs. no antiplatelet therapy (in a nested second randomization) for prevention of venous and arterial thrombotic events. In a subcohort without an ongoing indication for antiplatelet therapy at screening, the second randomization is performed to either antiplatelet or no antiplatelet therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years (male or female)
  • Acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
  • Currently admitted to an intensive care unit (ICU)

Key Exclusion Criteria:

  • Ongoing (>48 hours) or planned full-dose (therapeutic) anticoagulation for any indication
  • Ongoing or planned treatment with dual antiplatelet therapy
  • Contraindication to antithrombotic therapy or high risk of bleeding due to conditions including, but not limited to, any of the following:
  • History of intracranial hemorrhage, known central nervous system (CNS) tumor or CNS vascular abnormality
  • Active or recent major bleeding within the past 30 days with untreated source
  • Platelet count <70,000 or known functional platelet disorder
  • Fibrinogen <200 mg/dL
  • International normalized ratio (INR) >1.9
  • History of heparin-induced thrombocytopenia
  • Ischemic stroke within the past 2 weeks

Patients who meet the following criterion are excluded from the second randomization (antiplatelet therapy vs. no antiplatelet therapy):

  • Ongoing or planned antiplatelet therapy, including aspirin monotherapy

Treatment and study plan

Unfractionated Heparin IV

Drug

Unfractionated heparin (UFH) administered intravenously with a nomogram targeting an aPTT of 1.5-2.5 times the control as per institutional therapeutic target for treatment of VTE

Enoxaparin 1 mg/kg

Drug

Enoxaparin 1 mg/kg administered subcutaneously (SC) every 12 hours

Other names: Lovenox

clopidogrel

Drug

Clopidogrel 300 mg administered once orally on the day of randomization, followed by 75 mg administered once daily orally on subsequent days

Other names: Plavix

Unfractionated heparin SC

Drug

Heparin 5,000 units administered subcutaneous three times daily

Enoxaparin 40 mg SC

Drug

Enoxaparin 40 mg administered subcutaneously (SC) once daily (reduce to 30 mg if CrCl<30 ml/min)

Other names: Lovenox

Primary outcomes

  1. Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation

    Time frame: 28 days or until hospital discharge, whichever earlier

    The efficacy of these interventions was analyzed using an unmatched win ratio.

    • The number of wins was found by comparing every patient in the FDAC (Full-dose anticoagulation) arm to every patient in the SDPAC (Standard dose prophylactic anticoagulation) arm to determine a 'win' and totaling up the number of wins in each arm.
    • A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.
    • Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT.

  2. Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy

    Time frame: 28 days or until hospital discharge, whichever earlier

    The efficacy of these interventions was analyzed using an unmatched win ratio.

    • The number of wins was found by comparing every patient in the Anti-platelet group to every patient in the No Anti-platelet group arm to determine a 'win' and totaling up the number of wins in each arm.
    • A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.
    • Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia, or clinically silent DVT.

Secondary outcomes

  1. Clinically Evident Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation

    Time frame: 28 days or until hospital discharge, whichever earlier

    The efficacy of these interventions was analyzed using an unmatched win ratio.

    • The number of wins was found by comparing every patient in the FDAC (Full-dose anticoagulation) arm to every patient in the SDPAC (Standard dose prophylactic anticoagulation) arm to determine a 'win' and totaling up the number of wins in each arm.
    • A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.
    • Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia.

  2. Clinically Evident Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy

    Time frame: 28 days or until hospital discharge, whichever earlier

    The efficacy of these interventions was analyzed using an unmatched win ratio.

    • The number of wins was found by comparing every patient in the Anti-platelet group to every patient in the No Anti-platelet group arm to determine a 'win' and totaling up the number of wins in each arm.
    • A 'win' is a point in the favor of the arm it is given to. For each comparison of one patient in full dose arm compared to one patient in the standard dose arm, a 'win' is given to arm with the patient who had a component of the composite endpoint either lower in the hierarchy than the paired patient, or if the patient did not have any component of the composite while the paired patient did experience a component event of the composite.
    • Hierarchical composite: Death due to venous or arterial thrombosis, pulmonary embolism, clinically evident DVT, type 1 MI, ischemic stroke, systemic embolism or acute limb ischemia.

Sponsors and collaborators

Lead sponsor

The TIMI Study Group

Other

Registry information

Official study title

A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients

Acronym: COVID-PACT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2020
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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