A Randomized Trial of Anticoagulation Strategies in COVID-19

COVID-19 Clinical Trial

Official title:

A Randomized Trial of Anticoagulation Strategies in COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04359277
• Other study ID #: s20-00479
• Status: Terminated
• Phase: Phase 3
• Start date: April 21, 2020
• Est. completion date: September 20, 2020

Study information

• Verified date: October 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. >18 years of age

2. Hospitalized patient with a diagnosis of COVID-19

3. Elevated D-dimer within prior 48 hours. Definition of elevated D-dimer is site-determined

Exclusion Criteria:

1. Meeting alternative indication for higher-dose anticoagulation

1. Prevalent blood clot at the time of enrollment

2. D-dimer >10,000 ng/ml

3. Rapidly rising D-dimer (change in D-dimer >10X over the prior 48 hours)

4. Prior VTE

5. Atrial fibrillation (with a CHADS2 Score >1*)

2. Renal failure (Creatinine clearance <15 and/or requirement of renal replacement therapies)

3. Heparin induced thrombocytopenia within 100 days

4. Stroke within 30 days

5. Hemorrhagic stroke (ever)

6. GI bleed within 6 months

7. Platelet count <100,000

8. Anemia with a hemoglobin <9mg/dl

9. Pregnancy

10. Signs of active bleeding (e.g. a whole blood or PRBC transfusion in the past 30 days)

11. Other high bleeding risk (I.e. trauma, use of dual antiplatelet therapy)

12. CHF, Hypertension, Age>75 years, Diabetes, Prior stroke or TIA symptoms

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Enoxaparin Higher Dose
Drug: Enoxaparin Higher Dose Enoxaparin in 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 (may be used as an alternative) For Enoxaparin, AntiXA testing will be done after fourth injection only for participants with BMI >40 or weight > 150 kg as per institutional policy.
• 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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite incidence of: all-cause mortality, cardiac arrest, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, stroke, or shock		30 days
Secondary	Score on WHO Ordinal Scale	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 (%)	30 days
Secondary	Incidence of acute kidney injury (KDIGO criteria for Acute Kidney Injury (AKI))	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.	30 days
Secondary	Requirement of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)		30 days
Secondary	Cardiac injury	Measured by troponin and NTproBNPlevels	30 days
Secondary	Hypercoagulability	measured by D-dimer and fibrinogen levels	30 days
Secondary	Disseminated Intravascular Coagulation (DIC) Score	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.	30 days
Secondary	Length of Hospital Stay		30 days