<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04406389</url>
  </required_header>
  <id_info>
    <org_study_id>20-04021936</org_study_id>
    <nct_id>NCT04406389</nct_id>
  </id_info>
  <brief_title>Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if therapeutic dose anticoagulation (experimental&#xD;
      group) improves 30-day mortality in participants with COVID-19 compared to those patients&#xD;
      receiving the intermediate dose prophylaxis (control group). Following screening, subjects&#xD;
      will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation&#xD;
      treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 13, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Intensive Care Unit (ICU) Stay in Days</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of length of ICU stay in days between each treatment arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of major and clinically relevant non-major bleeding events</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">186</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Intermediate Dose Prophylaxis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one of the following interventions, at their physician's discretion:&#xD;
Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min&#xD;
Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min&#xD;
If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.&#xD;
Fondaparinux (if history of heparin-inducted thrombocytopenia [HIT]) 2.5 mg daily subcutaneously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic Dose Anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one of the following interventions, at their physician's discretion:&#xD;
Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).&#xD;
Enoxaparin 1 mg/kg subcutaneously every 12 hours&#xD;
Argatroban (if heparin-induced thrombocytopenia [HIT]), dosed according to institutional protocol.&#xD;
Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:&#xD;
≥100 kg: 10 mg daily&#xD;
&lt;100 kg but ≥50 kg: 7.5 mg daily&#xD;
&lt;50 kg: 5 mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin sodium</intervention_name>
    <description>Intermediate Dose Prophylaxis Arm:&#xD;
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min&#xD;
Therapeutic Dose Anticoagulation Arm:&#xD;
1 mg/kg subcutaneously every 12 hours</description>
    <arm_group_label>Intermediate Dose Prophylaxis</arm_group_label>
    <arm_group_label>Therapeutic Dose Anticoagulation</arm_group_label>
    <other_name>Lovenox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Unfractionated heparin</intervention_name>
    <description>Intermediate Dose Prophylaxis Arm:&#xD;
7,500 units subcutaneously every 8 hours&#xD;
Therapeutic Dose Anticoagulation Arm:&#xD;
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol</description>
    <arm_group_label>Intermediate Dose Prophylaxis</arm_group_label>
    <arm_group_label>Therapeutic Dose Anticoagulation</arm_group_label>
    <other_name>Sodium heparin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fondapariniux</intervention_name>
    <description>Intermediate Dose Prophylaxis Arm:&#xD;
2.5 mg daily subcutaneously&#xD;
Therapeutic Dose Anticoagulation Arm:&#xD;
Dose by weight:&#xD;
If greater than or equal to 100 kg: 10 mg daily&#xD;
If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily&#xD;
If less than 50 kg: 5 mg daily</description>
    <arm_group_label>Intermediate Dose Prophylaxis</arm_group_label>
    <arm_group_label>Therapeutic Dose Anticoagulation</arm_group_label>
    <other_name>Arixtra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Argatroban</intervention_name>
    <description>Therapeutic Dose Anticoagulation Arm:&#xD;
Dosed according to institutional protocol</description>
    <arm_group_label>Therapeutic Dose Anticoagulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years old&#xD;
&#xD;
          -  COVID-19 positive on (RT-PCR) nasopharyngeal swab, or suspected COVID-19 infection&#xD;
             with detectable SARS-CoV-2 IgG or IgM.&#xD;
&#xD;
          -  Intensive care unit (ICU) patient or non-ICU patient on invasive mechanical&#xD;
             ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental&#xD;
             oxygen of at least 4 liters per minute nasal cannula.&#xD;
&#xD;
          -  D dimer level greater than 700 ng/mL (3 times the upper limit of normal).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Objectively documented deep vein thrombosis or pulmonary embolism&#xD;
&#xD;
          -  Patients in whom there is very high suspicion for pulmonary embolism and are on&#xD;
             full-dose anticoagulation as per the treating physician&#xD;
&#xD;
          -  Platelets &lt;30,000 not due to disseminated intravascular coagulation (DIC), based on&#xD;
             the International Society of Thrombosis and Haemostasis (ISTH) criteria and American&#xD;
             Society of Hematology (ASH) Frequently Asked Questions&#xD;
&#xD;
          -  Active bleeding that poses a contraindication to therapeutic anticoagulation in the&#xD;
             opinion of the investigator.&#xD;
&#xD;
          -  History of bleeding diathesis (e.g., hemophilia, severe von Willebrand disease, severe&#xD;
             thrombocytopathy)&#xD;
&#xD;
          -  History of intracranial hemorrhage in the last 90 days&#xD;
&#xD;
          -  History of ischemic stroke in the past 2 weeks&#xD;
&#xD;
          -  Major neurosurgical procedure in the past 30 days&#xD;
&#xD;
          -  Cardiothoracic surgery in the past 30 days&#xD;
&#xD;
          -  Intra-abdominal surgery in the past 30 days&#xD;
&#xD;
          -  Intracranial malignancy&#xD;
&#xD;
          -  Patients who require therapeutic anticoagulation for other reasons like atrial&#xD;
             fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid&#xD;
             syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria T DeSancho, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria T DeSancho, MD, MSc</last_name>
    <phone>646-962-2065</phone>
    <email>mtd2002@med.cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Danielle Guarneri</last_name>
    <phone>212-746-0974</phone>
    <email>dag2037@med.cornell.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>New York Presbyterian Brooklyn Methodist Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Palmer</last_name>
      <email>map9505@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Danielle Guarneri</last_name>
      <email>dag2037@med.cornell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Andy Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria T DeSancho, MD, MSc</last_name>
      <phone>646-962-2065</phone>
      <email>mtd2002@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Danielle Guarneri</last_name>
      <phone>212-746-0974</phone>
      <email>dag2037@med.cornell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Maria T DeSancho, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.</citation>
    <PMID>32073213</PMID>
  </reference>
  <reference>
    <citation>Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.</citation>
    <PMID>32220112</PMID>
  </reference>
  <reference>
    <citation>Xiong TY, Redwood S, Prendergast B, Chen M. Coronaviruses and the cardiovascular system: acute and long-term implications. Eur Heart J. 2020 May 14;41(19):1798-1800. doi: 10.1093/eurheartj/ehaa231. No abstract available.</citation>
    <PMID>32186331</PMID>
  </reference>
  <reference>
    <citation>Young E. The anti-inflammatory effects of heparin and related compounds. Thromb Res. 2008;122(6):743-52. doi: 10.1016/j.thromres.2006.10.026. Epub 2007 Aug 28.</citation>
    <PMID>17727922</PMID>
  </reference>
  <reference>
    <citation>Esmon CT. Targeting factor Xa and thrombin: impact on coagulation and beyond. Thromb Haemost. 2014 Apr 1;111(4):625-33. doi: 10.1160/TH13-09-0730. Epub 2013 Dec 12.</citation>
    <PMID>24336942</PMID>
  </reference>
  <reference>
    <citation>Poterucha TJ, Libby P, Goldhaber SZ. More than an anticoagulant: Do heparins have direct anti-inflammatory effects? Thromb Haemost. 2017 Feb 28;117(3):437-444. doi: 10.1160/TH16-08-0620. Epub 2016 Dec 15.</citation>
    <PMID>27975101</PMID>
  </reference>
  <reference>
    <citation>Hanify JM, Dupree LH, Johnson DW, Ferreira JA. Failure of chemical thromboprophylaxis in critically ill medical and surgical patients with sepsis. J Crit Care. 2017 Feb;37:206-210. doi: 10.1016/j.jcrc.2016.10.002. Epub 2016 Oct 11.</citation>
    <PMID>27969572</PMID>
  </reference>
  <reference>
    <citation>Thachil J. The versatile heparin in COVID-19. J Thromb Haemost. 2020 May;18(5):1020-1022. doi: 10.1111/jth.14821. Epub 2020 Apr 27. No abstract available.</citation>
    <PMID>32239799</PMID>
  </reference>
  <reference>
    <citation>Cui S, Chen S, Li X, Liu S, Wang F. Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia. J Thromb Haemost. 2020 Jun;18(6):1421-1424. doi: 10.1111/jth.14830. Epub 2020 May 6.</citation>
    <PMID>32271988</PMID>
  </reference>
  <reference>
    <citation>Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.</citation>
    <PMID>32291094</PMID>
  </reference>
  <reference>
    <citation>Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.</citation>
    <PMID>15842354</PMID>
  </reference>
  <reference>
    <citation>Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Angles-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.</citation>
    <PMID>32367170</PMID>
  </reference>
  <reference>
    <citation>Middeldorp S, Coppens M, van Haaps TF, Foppen M, Vlaar AP, Muller MCA, Bouman CCS, Beenen LFM, Kootte RS, Heijmans J, Smits LP, Bonta PI, van Es N. Incidence of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020 Aug;18(8):1995-2002. doi: 10.1111/jth.14888. Epub 2020 Jul 27.</citation>
    <PMID>32369666</PMID>
  </reference>
  <reference>
    <citation>Goyal P, Choi JJ, Pinheiro LC, Schenck EJ, Chen R, Jabri A, Satlin MJ, Campion TR Jr, Nahid M, Ringel JB, Hoffman KL, Alshak MN, Li HA, Wehmeyer GT, Rajan M, Reshetnyak E, Hupert N, Horn EM, Martinez FJ, Gulick RM, Safford MM. Clinical Characteristics of Covid-19 in New York City. N Engl J Med. 2020 Jun 11;382(24):2372-2374. doi: 10.1056/NEJMc2010419. Epub 2020 Apr 17. No abstract available.</citation>
    <PMID>32302078</PMID>
  </reference>
  <reference>
    <citation>Paranjpe I, Fuster V, Lala A, Russak AJ, Glicksberg BS, Levin MA, Charney AW, Narula J, Fayad ZA, Bagiella E, Zhao S, Nadkarni GN. Association of Treatment Dose Anticoagulation With In-Hospital Survival Among Hospitalized Patients With COVID-19. J Am Coll Cardiol. 2020 Jul 7;76(1):122-124. doi: 10.1016/j.jacc.2020.05.001. Epub 2020 May 6. No abstract available.</citation>
    <PMID>32387623</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Anticoagulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</mesh_term>
    <mesh_term>Enoxaparin</mesh_term>
    <mesh_term>Enoxaparin sodium</mesh_term>
    <mesh_term>Argatroban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 24, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04406389
org study id: 20-04021936
nct id: NCT04406389
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to determine if therapeutic dose anticoagulation (experimental
      group) improves 30-day mortality in participants with COVID-19 compared to those patients
      receiving the intermediate dose prophylaxis (control group). Following screening, subjects
      will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation
      treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 30-day mortality
time frame: 30 days
description: Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
measure: Length of Intensive Care Unit (ICU) Stay in Days
time frame: 6 months
description: Comparison of length of ICU stay in days between each treatment arm.
measure: Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events
time frame: 6 months
description: Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm
measure: Number of major and clinically relevant non-major bleeding events
time frame: 6 months
description: Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.
arm group label: Intermediate Dose Prophylaxis
arm group type: Active Comparator
description: Subjects will receive one of the following interventions, at their physician's discretion:
Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min
Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min
If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours.
Fondaparinux (if history of heparin-inducted thrombocytopenia [HIT]) 2.5 mg daily subcutaneously
arm group label: Therapeutic Dose Anticoagulation
arm group type: Experimental
description: Subjects will receive one of the following interventions, at their physician's discretion:
Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol).
Enoxaparin 1 mg/kg subcutaneously every 12 hours
Argatroban (if heparin-induced thrombocytopenia [HIT]), dosed according to institutional protocol.
Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight:
≥100 kg: 10 mg daily
<100 kg but ≥50 kg: 7.5 mg daily
<50 kg: 5 mg daily
intervention type: Drug
intervention name: Enoxaparin sodium
description: Intermediate Dose Prophylaxis Arm:
0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
Therapeutic Dose Anticoagulation Arm:
1 mg/kg subcutaneously every 12 hours
arm group label: Intermediate Dose Prophylaxis
arm group label: Therapeutic Dose Anticoagulation
other name: Lovenox
intervention type: Drug
intervention name: Unfractionated heparin
description: Intermediate Dose Prophylaxis Arm:
7,500 units subcutaneously every 8 hours
Therapeutic Dose Anticoagulation Arm:
Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol
arm group label: Intermediate Dose Prophylaxis
arm group label: Therapeutic Dose Anticoagulation
other name: Sodium heparin
intervention type: Drug
intervention name: Fondapariniux
description: Intermediate Dose Prophylaxis Arm:
2.5 mg daily subcutaneously
Therapeutic Dose Anticoagulation Arm:
Dose by weight:
If greater than or equal to 100 kg: 10 mg daily
If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
If less than 50 kg: 5 mg daily
arm group label: Intermediate Dose Prophylaxis
arm group label: Therapeutic Dose Anticoagulation
other name: Arixtra
intervention type: Drug
intervention name: Argatroban
description: Therapeutic Dose Anticoagulation Arm:
Dosed according to institutional protocol
arm group label: Therapeutic Dose Anticoagulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria T DeSancho, MD, MSc
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Maria T DeSancho, MD, MSc
phone: 646-962-2065
email: mtd2002@med.cornell.edu
last name: Danielle Guarneri
phone: 212-746-0974
email: dag2037@med.cornell.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
PMID: 32073213
citation: Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.
PMID: 32220112
citation: Xiong TY, Redwood S, Prendergast B, Chen M. Coronaviruses and the cardiovascular system: acute and long-term implications. Eur Heart J. 2020 May 14;41(19):1798-1800. doi: 10.1093/eurheartj/ehaa231. No abstract available.
PMID: 32186331
citation: Young E. The anti-inflammatory effects of heparin and related compounds. Thromb Res. 2008;122(6):743-52. doi: 10.1016/j.thromres.2006.10.026. Epub 2007 Aug 28.
PMID: 17727922
citation: Esmon CT. Targeting factor Xa and thrombin: impact on coagulation and beyond. Thromb Haemost. 2014 Apr 1;111(4):625-33. doi: 10.1160/TH13-09-0730. Epub 2013 Dec 12.
PMID: 24336942
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responsible party type: Sponsor
mesh term: COVID-19
mesh term: Heparin
mesh term: Calcium heparin
mesh term: Enoxaparin
mesh term: Enoxaparin sodium
mesh term: Argatroban
sharing ipd: No
submitted: August 24, 2023