A Randomized Trial of Anticoagulation Strategies in COVID-19
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ClinicalTrials.gov Identifier: NCT04359277 |
Recruitment Status :
Terminated
(the PROTECT study is being transitioned to ACTIV4 ACUTE anticoagulation inpatient study)
First Posted : April 24, 2020
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Enoxaparin Higher Dose Drug: Lower-dose prophylactic anticoagulation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 77 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 an elevated D-dimer. Patients will be randomized to higher-dose (e.g. therapeutic) anticoagulation versus lower-dose (e.g. prophylactic) 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 21, 2020 |
Actual Primary Completion Date : | September 20, 2020 |
Actual Study Completion Date : | September 20, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Higher-dose anticoagulation |
Drug: Enoxaparin Higher Dose
Drug: Enoxaparin Higher Dose
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
Drug: Lower-dose prophylactic anticoagulation
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 |
- Composite incidence of: all-cause mortality, cardiac arrest, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, stroke, or shock [ Time Frame: 30 days ]
- Score on WHO Ordinal Scale [ Time Frame: 30 days ]
0 = Uninfected; no viral RNA detected Ambulatory
- = Asymptomatic; viral RNA detected
- = Symptomatic: Independent
- = Symptomatic: assistance needed Hospitalized: Mild disease
- = Hospitalized; no oxygen therapy
- = Hospitalized; oxygen by mask or nasal prongs
- = Hospitalized; oxygen by NIV or High flow
- = Intubation & Mechanical ventilation, pO2/FIO2 >/= 150 or SpO2/FIO2
- = Mechanical ventilation pO2/FIO2 <
150 (SpO2/FIO2 <200) 9 = Mechanical ventilation pO2/FIO2 < 150 and vasopressors, dialysis 10 = Dead N (%)
- Incidence of acute kidney injury (KDIGO criteria for Acute Kidney Injury (AKI)) [ Time Frame: 30 days ]
AKI is defined as any of the following (Not Graded):
- Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or
- Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or- Urine volume o0.5 ml/kg/h for 6 hours.
- Requirement of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: 30 days ]
- Cardiac injury [ Time Frame: 30 days ]Measured by troponin and NTproBNPlevels
- Hypercoagulability [ Time Frame: 30 days ]measured by D-dimer and fibrinogen levels
- Disseminated Intravascular Coagulation (DIC) Score [ Time Frame: 30 days ]
Platelet Count >100 x 109/L 0 Points >50 - <100 x 109/L 1 Point <50 x 109/L 2 Points Increase in Fibrin-related Markers [D Dimers] No change 0 Points Moderate rise 2 Points Strong rise 3 Points Prothrombin Time [PT] Prolongation 3 s or less 0 Points >3 s but <6 s 1 Point >6 s 2 Points Fibrinogen [Clauss] Level >1.0 g/L 0 Points <1.0 g/L 1 Point
Score 0-8
Interpretation of Score < 5 Suggestive of non-overt/low grade DIC. Repeat in 1-2 days.
≥ 5 Laboratory evidence consistent with overt DIC.
- Length of Hospital Stay [ Time Frame: 30 days ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >18 years of age
- Hospitalized patient with a diagnosis of COVID-19
- Elevated D-dimer within prior 48 hours. Definition of elevated D-dimer is site-determined
Exclusion Criteria:
-
Meeting alternative indication for higher-dose anticoagulation
- Prevalent blood clot at the time of enrollment
- D-dimer >10,000 ng/ml
- Rapidly rising D-dimer (change in D-dimer >10X over the prior 48 hours)
- Prior VTE
- Atrial fibrillation (with a CHADS2 Score >1*)
- Renal failure (Creatinine clearance <15 and/or requirement of renal replacement therapies)
- Heparin induced thrombocytopenia within 100 days
- Stroke within 30 days
- Hemorrhagic stroke (ever)
- GI bleed within 6 months
- Platelet count <100,000
- Anemia with a hemoglobin <9mg/dl
- Pregnancy
- Signs of active bleeding (e.g. a whole blood or PRBC transfusion in the past 30 days)
- Other high bleeding risk (I.e. trauma, use of dual antiplatelet therapy)
- CHF, Hypertension, Age>75 years, Diabetes, Prior stroke or TIA symptoms

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
United States, New York | |
NYU Langone Health | |
New York, New York, United States, 10016 |
Principal Investigator: | Jeffrey Berger, MD | NYU Langone Health |
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: | October 8, 2020 |
Last Verified: | October 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. |
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 |
Enoxaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |