Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Trial of Anticoagulation Strategies in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359277
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a randomized open label trial to compare effectiveness of two dosing regimens currently used for prevention of clotting events in COVID-19 positive inpatients. Both doses and routes of anticoagulation regimens are currently used in COVID-19 positive inpatients at NYU Langone Health.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Enoxaparin Higher Dose Drug: Lower-dose prophylactic anticoagulation Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study is designed as an open label randomized trial of patients hospitalized COVID-19 positive patients with a D-dimer >500 ng/ml. Patients will be randomized to higher-dose anticoagulation versus lower-dose (e.g. prophylactic-dose) anticoagulation in 1:1 ratio.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Anticoagulation Strategies in COVID-19
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : April 16, 2021
Estimated Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Higher-dose anticoagulation Drug: Enoxaparin Higher Dose
  • Enoxaparin will be preferred in non-intubated patients with a Cr Clearance of > 30
  • Enoxaparin 1mg/kg q12 SQ hours for weight 50-150kg
  • Enoxaparin 0.75mg/kg q12 SQ hours for weight >150kg or BMI >40
  • Unfractionated IV heparin titrated to a goal antiXa of 0.3-0.5 unit/mL (will be preferred in intubated patients)

For Enoxaparin, AntiXA testing will be done after fourth injection only for participants with BMI >40 or weight > 150 kg as per institutional policy.


Experimental: Lower-dose prophylactic anticoagulation Drug: Lower-dose prophylactic anticoagulation
  • Heparin 5000 units every 12 or every 8 hours or 7500 units every 8 hours for BMI > 40 or weight > 150 kg, or
  • Enoxaparin 40mg every 24 hours or 30mg every 12 hours or every 24 hours (with CrCl < 30mL/min) SQ or
  • Enoxaparin 40mg every 12 hours SQ for weight >150kg or BMI >40-50
  • Enoxaparin 60 mg every 12 hours SQ for BMI >50 For Enoxaparin, AntiXA testing will be done after fourth injection only for participants with BMI >40 or weight > 150kg as per institutional policy.

For patients that develop acute kidney injury, and received enoxaparin, transition to IV unfractionated heparin by checking antiXa when next dose of enoxaparin would be due and initiating IV heparin when antiXa <0.7 IU/mL





Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 1 year ]
  2. Incidence of Cardiac Arrest [ Time Frame: 21 days ]
  3. Incidence of symptomatic Deep Venous Thrombosis [ Time Frame: 21 days ]
  4. Incidence of Pulmonary Embolism [ Time Frame: 21 days ]
  5. Incidence of Arterial thromboembolism [ Time Frame: 21 days ]
  6. Incidence of myocardial infarction [ Time Frame: 21 days ]
  7. Incidence of hemodynamic shock [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Incidence of Renal failure [ Time Frame: 21 days ]
  2. Days of hypoxemia [ Time Frame: 21 days ]
    SpO2 <93% on room air, or requiring supplemental oxygen, or mechanical ventilatory support

  3. Cardiac injury (e.g. troponin, NTproBNP) [ Time Frame: 21 days ]
  4. Hypercoagulability (e.g. D-dimer, fibrinogen) [ Time Frame: 21 days ]
  5. DIC score [ Time Frame: 21 days ]
  6. Incidence of major bleeding [ Time Frame: 21 days ]
  7. Time to change in NEWS2 from baseline [ Time Frame: 30 days ]
  8. Requirement of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: 21 days ]
  9. Requirement of non-invasive ventilation or high flow oxygen devices [ Time Frame: 21 days ]
  10. Requirement of supplemental oxygen [ Time Frame: 21 days ]

Other Outcome Measures:
  1. Length of hospital stay [ Time Frame: 21 days ]
  2. Number of days requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: 21 days ]
  3. Number of days requiring non-invasive ventilation or high flow oxygen devices [ Time Frame: 21 days ]
  4. Number of days requiring supplemental oxygen [ Time Frame: 21 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. >18 years of age
  2. Hospitalized patient with a diagnosis of COVID-19
  3. Consistent with the institution guidelines, D-dimer > 500ng/ml

    1. If a D-Dimer is between 500ng/ml to 2,000ng/ml - there appears to be clinical equipoise by the NYU medical community
    2. If a D-Dimer is >2,000 and < 10,000 and is not on a higher dose anticoagulation and a blood clot is not suspected and there is clinical equipoise, a patient may be approached for enrollment

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Meeting alternative indication for higher-dose anticoagulation

    1. Prevalent blood clot at the time of enrollment
    2. On renal replacement therapies (CRRT, CVVH)
    3. D-dimer >10,000 ng/ml
    4. Change in D-dimer >6X over the admission lab value
    5. Renal failure requiring renal replacement therapy
    6. Prior VTE
    7. Atrial fibrillation (with a CHADS2 Score >1) on oral anticoagulant therapy already
  2. Prior Heparin induced thrombocytopenia within 100 days
  3. Stroke within 30 days
  4. Prior hemorrhagic stroke (ever)
  5. GI bleed within the past 6 months
  6. Platelet count <100,000
  7. Pregnancy
  8. Anemia with a hemoglobin <9mg/dl
  9. Signs of active bleeding (e.g. requirement of a blood transfusion in the past 30 days)
  10. Other high bleeding risk (I.e. trauma, use of dual antiplatelet therapy)
  11. Renal failure on admission (by RIFLE criteria 3X change in serum creatinine from baseline or >75% reduction in GFR or urine output <0.3ml/kg over 24 hours or anuria for 12 hours)
  12. Subjects who have no capacity to consent for themselves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359277


Contacts
Layout table for location contacts
Contact: Jeffrey Berger, MD 212-263-4004 PROTECT.COVID19@nyulangone.org

Locations
Layout table for location information
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Jeffrey S Berger, MD       PROTECT.COVID19@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey Berger, MD NYU Langone Health
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04359277    
Other Study ID Numbers: s20-00479
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: jeffrey.berger@nyumc.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: Requests may be directed to: jeffrey.berger@nyumc.org. To gain access, data requestors will need to sign a data access agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action