COVID-19Phase 4IMPROVENCT04367831
Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19
A Phase 4 study testing Enoxaparin Prophylactic Dose, Heparin Infusion and Heparin SC in people with COVID-19 and Venous Thromboses, run by Columbia University at 1 site in United States.
Trial summary
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Venous Thromboses, Arterial Thrombosis
- What is being tested?
- Enoxaparin Prophylactic Dose, Heparin Infusion and Heparin SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2020to 12 May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)
- New admission to eligible CUIMC ICUs within 5 days
- Transfer from nonparticipating to participating ICU is eligible if otherwise meets eligibility criteria.
- Patients transferred between participating ICUs will maintain initial treatment assignment.
- Patients not on therapeutic anticoagulation and who were already admitted to participating ICU within 5 days of trial initiation are additionally eligible.
Who cannot join
- Weight under 50kg
- Contraindication to anticoagulation in the opinion of the treating clinician including
- overt bleeding
- platelet count <50,000
- Bleeding Academic Research Consortium (BARC) major bleeding in the past 30 days
- Gastrointestinal (GI) bleeding within 3 months
Show all 24Show fewer
- history of intracranial hemorrhage
- Ischemic stroke within the past 2 weeks
- craniotomy/major neurosurgery within the past 30 days
- cardiothoracic surgery within the past 30 days
- intra-abdominal surgery within 30 days prior to enrollment
- Head or spinal trauma in the last months
- History of uncorrected cerebral aneurysm or arteriovenous malformation (AVM)
- Intracranial malignancy
- Presence of an epidural or spinal catheter
- Recent major surgery within the last 14 days
- Decrease in hemoglobin >3 g/dL over the last 24 hours
- Allergic reaction to anticoagulants (e.g. Heparin Induced Thrombocytopenia) as documented in the electronic health records. Extracorporeal membrane oxygenation (ECMO) support or other mechanical circulatory support.
- Severe chronic liver dysfunction (history of portosystemic hypertension (HTN), esophageal varices, or Child-Pugh class C or above or similar Model For End-Stage Liver Disease (MELD) scores), abnormality in liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin) 5 times greater than upper normal limit.
- A history of congenital bleeding diatheses or anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia)
- Treating physician preference for therapeutic anticoagulation
- Enrollment in other concurrent trials related to anticoagulant or antiplatelet therapy
- Existing treatment with therapeutic anticoagulation during the previous 7 days of hospitalization prior to ICU admission (e.g. for venous thromboembolism (VTE), atrial fibrillation, mechanical valve, etc).
- Do-not-resuscitate (DNR) /do-not-intubate (DNI) or comfort measures only (CMO) orders prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID)
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Read the detailed description
Hemostatic, biomarker, and inflammatory changes are common in severe manifestations of coronavirus disease 2019 (COVID-19).Such factors, as well as the bedridden status and critical illness may constitute a prothrombotic milieu, predisposing to venous and arterial thrombosis. However, the optimal antithrombotic regimen for patients with COVID-19, especially those with severe disease, remains uncertain and is currently an area of active clinical interest. Prophylactic-dose anticoagulation is generally recommended for acutely ill hospitalized patients. However, given the hemostatic abnormalities of severe COVID-19 illness, it is unknown whether more intensive anticoagulation is preferred to reduce the risk of thrombotic events, potentially mitigating microvascular and macrovascular thrombi and even disseminated intravascular coagulation (DIC). Further, the risks of therapeutic dose anticoagulation must be weighed against the bleeding risks inherent to this approach. To address this critical gap in knowledge in an area of clinical equipoise, the investigators plan to conduct a cluster-randomized trial in patients admitted to intensive care units (ICUs) in a large volume academic medical center to select the best anticoagulation intervention.
- Conditions
- COVID-19, Venous Thromboses, Arterial Thrombosis
- Being tested
- Enoxaparin Prophylactic Dose, Heparin Infusion, Heparin SC, Enoxaparin/Lovenox Intermediate Dose
- Keywords
- COVID-19, coronavirus, anticoagulation
- Medical subject headings
- COVID-19, Venous Thrombosis, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Prophylactic DoseDrug
Also called Lovenox
Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
- BMI < 40 kg/m2: Enoxaparin 40 mg SC daily
- BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
- BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h
Heparin InfusionDrug
Also called Heparin
Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
Heparin SCDrug
Also called Heparin
Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
Enoxaparin/Lovenox Intermediate DoseDrug
Also called Lovenox
If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: intermediate-dose anticoagulation | Experimental | If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL.
If eGFR <30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL Receives: Drug: Heparin Infusion; Drug: Enoxaparin/Lovenox Intermediate Dose |
| Control arm: prophylaxis | Active comparator | Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
If eGFR ≥30 mL/min (stable kidney function):
1. BMI < 40 kg/m2: Enoxaparin 40 mg SC daily
2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
3. BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h
If eGFR < 30 mL/min or acute kidney injury:
1. 50-120 kg: Unfractionated heparin 5000 units SC q8h
2. >120 kg: Unfractionated heparin 7500 units SC q8h
If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour Receives: Drug: Enoxaparin Prophylactic Dose; Drug: Heparin SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU
Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Measured: Discharge from ICU or 30 days
Secondary outcomes (5)
Total Number of Patients With Clinically Relevant Venous or Arterial Thrombotic Events in ICU
Composite of being alive and with clinically relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Measured: Discharge from hospital or 30 days
ICU Length of Stay
Length of stay measured in days.
Measured: Discharge from ICU, up to 36 days
Total Number of Patients With the Need for Renal Replacement Therapy in the ICU
The impact of intermediate-dose anti-coagulation compared with prophylactic anti-coagulation on rates of acute kidney injury and renal recovery in the ICU will be measured with the total number of patients who need of renal replacement therapy in the ICU.
Measured: Discharge from ICU or 30 days
Total Number of Patients With Major Bleeding in the ICU
Major bleeding will be assessed by BARC criteria (> BARC 3), also explored by International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction (TIMI) criteria.
Measured: Discharge from ICU or 30 days
Hospital Length of Stay
Length of stay measured in days.
Measured: Discharge from ICU, up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start2 May 2020
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahil A. Parikh, Columbia University
- Investigators
- Ajay Kirtane, MD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367831
- Sponsor's protocol ID
- AAAS8980
- Acronym
- IMPROVE
- Status last verified
- Nov 2024
- First submitted
- 27 Apr 2020
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
PubMed 33502773Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
PubMed 32407672
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID)
- ClinicalTrials.gov ID
- NCT04367831
- Acronym / sponsor ID
- IMPROVE / AAAS8980
- Conditions
- COVID-19, Venous Thromboses, Arterial Thrombosis
- Keywords
- COVID-19, coronavirus, anticoagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Detailed description
Hemostatic, biomarker, and inflammatory changes are common in severe manifestations of coronavirus disease 2019 (COVID-19).Such factors, as well as the bedridden status and critical illness may constitute a prothrombotic milieu, predisposing to venous and arterial thrombosis. However, the optimal antithrombotic regimen for patients with COVID-19, especially those with severe disease, remains uncertain and is currently an area of active clinical interest. Prophylactic-dose anticoagulation is generally recommended for acutely ill hospitalized patients. However, given the hemostatic abnormalities of severe COVID-19 illness, it is unknown whether more intensive anticoagulation is preferred to reduce the risk of thrombotic events, potentially mitigating microvascular and macrovascular thrombi and even disseminated intravascular coagulation (DIC). Further, the risks of therapeutic dose anticoagulation must be weighed against the bleeding risks inherent to this approach. To address this critical gap in knowledge in an area of clinical equipoise, the investigators plan to conduct a cluster-randomized trial in patients admitted to intensive care units (ICUs) in a large volume academic medical center to select the best anticoagulation intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: intermediate-dose anticoagulation | Experimental | Drug: Heparin Infusion, Drug: Enoxaparin/Lovenox Intermediate DoseIf estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily or unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1-0.3 U/mL. If eGFR <30 mL/min or acute kidney injury or CRRT: Unfractionated heparin infusion at 10 units/kg/hour (minimum 500 units/hour if CRRT) with goal anti-Xa 0.1-0.3 U/mL |
| Control arm: prophylaxis | Active comparator | Drug: Enoxaparin Prophylactic Dose, Drug: Heparin SCProphylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines): If eGFR ≥30 mL/min (stable kidney function): 1. BMI < 40 kg/m2: Enoxaparin 40 mg SC daily 2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h 3. BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h If eGFR < 30 mL/min or acute kidney injury: 1. 50-120 kg: Unfractionated heparin 5000 units SC q8h 2. >120 kg: Unfractionated heparin 7500 units SC q8h If CRRT: Unfractionated heparin infusion pre-filter at 500 units/hour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)
- New admission to eligible CUIMC ICUs within 5 days
Key exclusion criteria (24 listed)
- Weight under 50kg
- Contraindication to anticoagulation in the opinion of the treating clinician including
- Severe chronic liver dysfunction (history of portosystemic hypertension (HTN), esophageal varices, or Child-Pugh class C or above or similar Model For End-Stage Liver Disease (MELD) scores), abnormality in liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin) 5 times greater than upper normal limit.
- A history of congenital bleeding diatheses or anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia)
- Treating physician preference for therapeutic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin Prophylactic DoseAlso: LovenoxProphylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines): If eGFR ≥30 mL/min (stable kidney function): 1. BMI < 40 kg/m2: Enoxaparin 40 mg SC daily 2. BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h 3. BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h | Drug | Control arm: prophylaxis |
| Heparin InfusionAlso: HeparinUnfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL. | Drug | Intervention arm: intermediate-dose anticoagulation |
| Heparin SCAlso: HeparinUnfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours. | Drug | Control arm: prophylaxis |
| Enoxaparin/Lovenox Intermediate DoseAlso: LovenoxIf estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily. | Drug | Intervention arm: intermediate-dose anticoagulation |
Primary outcome
Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU
Time frame: Discharge from ICU or 30 days
Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
5 secondary outcomes
Total Number of Patients With Clinically Relevant Venous or Arterial Thrombotic Events in ICU
Time frame: Discharge from hospital or 30 days
ICU Length of Stay
Time frame: Discharge from ICU, up to 36 days
Total Number of Patients With the Need for Renal Replacement Therapy in the ICU
Time frame: Discharge from ICU or 30 days
Total Number of Patients With Major Bleeding in the ICU
Time frame: Discharge from ICU or 30 days
Hospital Length of Stay
Time frame: Discharge from ICU, up to 36 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35244208Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33502773Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
- Derived from this study: PubMed 32407672Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Kirtane, MD study chair
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin Prophylactic Dose, Heparin Infusion and Heparin SC in people with COVID-19 and Venous Thromboses, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Patients Who Were Alive and Without Venous/Thrombotic Events in ICU (time frame: Discharge from ICU or 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367831, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.