COVID-19Phase 4FREEDOM COVIDNCT04512079
FREEDOM COVID-19 Anticoagulation Strategy
A Phase 4 study testing Enoxaparin and Apixaban in people with COVID-19 and SARS-CoV-2, run by Valentin Fuster at 21 sites in 5 countries.
Trial summary
Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Enoxaparin and Apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,460 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 8 Sep 2020to 30 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization within the prior 24 hours for either confirmed (based on PCR or antigen positive test for SARS-CoV-2) or suspected COVID-19 based on 3 criteria (all 3 must be present for suspected cases):
- Fever >38 degrees Celsius
- O2 saturation ≤94
- Abnormal laboratory marker (at least 1):
- d-dimer ≥1.0 μg /mL ii. CRP >2 mg/L iii. Ferritin >300 μg /L iv. Lymphopenia <1500 cells /m3
- Patient or legal guardian provides written informed consent
Who cannot join
- Age <18 years
- Mechanical ventilation on admission or high likelihood for the need for invasive mechanical ventilation within 24 hours of admission
- Anticipated duration of hospital stay <72 hours
- Treatment with therapeutic dose UFH or LMWH, vitamin K antagonists, or NOACs within seven days
- Active bleeding
- Risk factors for bleeding, including:
Show all 28Show fewer
- intracranial surgery or stroke within 3 months
- history of intracerebral arteriovenous malformation
- cerebral aneurysm or mass lesions of the central nervous system
- intracranial malignancy
- history of intracranial bleeding
- history of bleeding diatheses (e.g., hemophilia)
- history of gastrointestinal bleeding within previous 3 months
- thrombolysis within the previous 7 days
- presence of an epidural or spinal catheter
- recent major surgery <14 days
- uncontrolled hypertension (sBP > 200 mmHg or dBP > 120 mmHg)
- other physician-perceived contraindications to anticoagulation
- Platelet count <50 x109/L, INR >2.0, or baseline aPTT >50 seconds
- Hemoglobin <80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur)
- current treatment with antithrombotics or antiplatelet agents including but not limited to ticagrelor, prasugrel, and aspirin> 100mg, or non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, etc.) due to increased risk of bleeding, unless such agents can be permanently discontinued (aspirin <= 100mg and clopidogrel <=75mg is permitted)
- Acute or subacute bacterial endocarditis
- History of heparin induced thrombocytopenia (HIT) or other heparin allergy including hypersensitivity
- Patients with non-COVID-19 related clinical condition for which life expectancy is <6 months
- Pregnancy (women of childbearing potential are required to have a negative pregnancy test prior to enrollment)
- Active enrollment in other trials related to anticoagulation
- Patients has end stage kidney disease (ESKD) on chronic dialysis
- Patient is a member of a vulnerable population: In the judgment of the investigator the patient is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
India7 sites
Eternal Heart Care Centre and Research Ins Pvt Ltd.
Jaipur
Jaipur National University
Jaipur
Sawai Mann Singh Hospital
Jaipur
Jaslok Hospital & Research Center
Mumbai
Saifee Hospital
Mumbai
Sengupta Hospital & Research Institute
Nagpur
D Y Patil University School of Medicine & D Y Patil Hospital
Navi Mumbai
Colombia6 sites
Clínica de la Costa
Barranquilla
Clínica Shaio
Bogotá
Fundación Cardioinfantil
Bogotá
Fundacion Oftalmológica de Santander - Foscal
Bucaramanga
Centro Médico Imbanaco
Cali
CardioVid
Medellín
Mexico5 sites
Hospital Cardiológica Aguascalientes
Aguascalientes
Centro Médico Nacional 20 de Noviembre
Mexico City
Christus Muguerza Hospital Alta Especialidad
Monterrey
Centro de Estudios Clinicos de Querétaro S.C.
Querétaro City
Centro Medico Hospital del Prado
Tijuana
Brazil2 sites
Instituto do Coração - INCOR
São Paulo
Instituto Prevent Senior - IPS
São Paulo
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: FREEDOM COVID Anticoagulation Strategy Randomized Trial
Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. As the number of affected individuals continues to climb, effective strategies for treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed predominantly in the lungs but also throughout the cardiovascular system. Thus, while acute respiratory distress syndrome remains a feared complication, new thromboembolic disease has emerged as a common and potentially catastrophic manifestation of COVID-19.
Read the detailed description
This is a Prospective, multi-center, open label, randomized controlled comparative safety and effectiveness trial with objectives: 1. To determine the effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19 and 2. To determine the safety of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19. Observational analyses have suggested potential benefit for in-hospital use of anticoagulation. Yet, due to a lack of rigorous evidence for optimal anticoagulation regimens, practice patterns among hospitalized patients with COVID-19 vary significantly. Specifically, the choice of anticoagulant, dosing, and duration of treatment are not well understood. A preliminary analysis of approximately 2700 patients admitted to the Mount Sinai Health System (MSHS) in New York, demonstrated an association between in-hospital administration of therapeutic Anticoagulation (AC) and improved survival compared to no or prophylactic dose AC. A subsequent analysis under review of a larger 4400 patient cohort with longer follow up demonstrated similar associations with reduction in the risk of mortality and risk of intubation. Further analyses suggest more pronounced benefit with therapeutic as opposed to prophylactic doses. Bleeding rates were generally low overall, but higher among patients on therapeutic anticoagulation. Finally, though exploratory in nature, a potential signal for benefit was observed for patients on novel oral anticoagulant therapy (primarily apixaban) at therapeutic doses compared to low molecular weight heparin. Ultimately, randomized controlled trials are needed to elucidate the optimal anticoagulation regimen to improve outcomes in patients hospitalized with COVID-19.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Enoxaparin, Apixaban
- Keywords
- Randomization, Hospitalization, PCR or Antigen Positive Test, Abnormal Laboratory Maker, Anticoagulation, Apixaban
- Medical subject headings
- COVID-19, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Prophylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl <30 mL/min) Full-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl <30 mL/min)
ApixabanDrug
(5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL)
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Enoxaparin | Active comparator | Prophylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl <30 mL/min) Receives: Drug: Enoxaparin |
| Full Dose Enoxaparin | Active comparator | Full-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl <30 mL/min) Receives: Drug: Enoxaparin |
| Apixaban | Experimental | Apixaban (5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL) Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first event
The time to first event rate within 30 days of randomization of the composite of all-cause mortality, intubation requiring mechanical ventilation, systemic thromboembolism (including pulmonary emboli) confirmed by imaging or requiring surgical intervention OR ischemic stroke confirmed by imaging.
Measured: 30 days
Number of in-hospital rate of BARC 3 or 5
Number of in-hospital rate of BARC 3 or 5 bleeding (binary). BARC Type 3: a. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
- Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
- Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. BARC Type 5:
- Probable fatal bleeding
- Definite fatal bleeding (overt or autopsy or imaging confirmation)
Measured: 30 days
Secondary outcomes (16)
Number of participants with Myocardial infarction
Myocardial infarction (according to the 4th universal definition, types 1,2, and 3)
Measured: 30 days after randomization
Number of participants with Myocardial infarction
Myocardial infarction (according to the 4th universal definition, types 1,2, and 3)
Measured: 90 days after randomization
Number of participants with Deep Vein Thrombosis
Deep vein thrombosis with confirmation on imaging
Measured: 30 days after randomization
Number of participants with Deep Vein Thrombosis
Deep vein thrombosis with confirmation on imaging
Measured: 90 days after randomization
Number of participants requiring Ventilation
Intubation and mechanical ventilation
Measured: 30 after randomization
Number of participants requiring Ventilation
Intubation and mechanical ventilation
Measured: 90 days after randomization
Number of All Death
All-cause death
Measured: 30 days after randomization
Number of All Death
All-cause death
Measured: 90 days after randomization
Cause of Death
Cause of Death
Measured: 30 days after randomization
Cause of Death
Cause of Death
Measured: 90 days after randomization
Number of participants with Stroke
Stroke confirmed by imaging or autopsy (all, ischemic and hemorrhagic)
Measured: 30 days after randomization
Number of participants with Stroke
Stroke confirmed by imaging or autopsy (all, ischemic and hemorrhagic)
Measured: 90 days after randomization
Number of participants with Pulmonary Emboli
Pulmonary emboli confirmed by imaging or autopsy
Measured: 30 days after randomization
Number of participants with Pulmonary Emboli
Pulmonary emboli confirmed by imaging or autopsy
Measured: 90 days after randomization
Number of participants with Systemic Thromboembolism
Systemic thromboembolism confirmed by imaging or requiring surgical intervention
Measured: 30 days after randomization
Number of participants with Systemic Thromboembolism
Systemic thromboembolism confirmed by imaging or requiring surgical intervention
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start8 Sep 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Model description
- Study participants will be randomized in a 1:1:1 fashion to 1 of 3 arms: 1. Prophylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl \<30 mL/min) 2. Full-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl \<30 mL/min) 3. Apixaban (5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL)
- Masking
- None (open label)
- Enrolment
- 3,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentin Fuster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Valentin Fuster, Icahn School of Medicine at Mount Sinai
- Investigators
- Valentin Fuster, MD,PhD, Principal investigator, Icahn School of Medicine at Mount SinaiAnu Lala, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512079
- Sponsor's protocol ID
- GCO 20-2115
- Acronym
- FREEDOM COVID
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
Publications
Stone GW, Farkouh ME, Lala A, Tinuoye E, Dressler O, Moreno PR, Palacios IF, Goodman SG, Esper RB, Abizaid A, Varade D, Betancur JF, Ricalde A, Payro G, Castellano JM, Hung IFN, Nadkarni GN, Giustino G, Godoy LC, Feinman J, Camaj A, Bienstock SW, Furtado RHM, Granada C, Bustamante J, Peyra C, Contreras J, Owen R, Bhatt DL, Pocock SJ, Fuster V; FREEDOM COVID Anticoagulation Strategy Randomized Trial Investigators. Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19. J Am Coll Cardiol. 2023 May 9;81(18):1747-1762. doi: 10.1016/j.jacc.2023.02.041. Epub 2023 Mar 6.
PubMed 36889611Farkouh ME, Stone GW, Lala A, Bagiella E, Moreno PR, Nadkarni GN, Ben-Yehuda O, Granada JF, Dressler O, Tinuoye EO, Granada C, Bustamante J, Peyra C, Godoy LC, Palacios IF, Fuster V. Anticoagulation in Patients With COVID-19: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Mar 8;79(9):917-928. doi: 10.1016/j.jacc.2021.12.023.
PubMed 35241226
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREEDOM COVID Anticoagulation Strategy Randomized Trial
- ClinicalTrials.gov ID
- NCT04512079
- Acronym / sponsor ID
- FREEDOM COVID / GCO 20-2115
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- Randomization, Hospitalization, PCR or Antigen Positive Test, Abnormal Laboratory Maker, Anticoagulation, Apixaban
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,460 participants (actual)
- Lead sponsor
- Valentin FusterUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. As the number of affected individuals continues to climb, effective strategies for treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed predominantly in the lungs but also throughout the cardiovascular system. Thus, while acute respiratory distress syndrome remains a feared complication, new thromboembolic disease has emerged as a common and potentially catastrophic manifestation of COVID-19.
Detailed description
This is a Prospective, multi-center, open label, randomized controlled comparative safety and effectiveness trial with objectives: 1. To determine the effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19 and 2. To determine the safety of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19. Observational analyses have suggested potential benefit for in-hospital use of anticoagulation. Yet, due to a lack of rigorous evidence for optimal anticoagulation regimens, practice patterns among hospitalized patients with COVID-19 vary significantly. Specifically, the choice of anticoagulant, dosing, and duration of treatment are not well understood. A preliminary analysis of approximately 2700 patients admitted to the Mount Sinai Health System (MSHS) in New York, demonstrated an association between in-hospital administration of therapeutic Anticoagulation (AC) and improved survival compared to no or prophylactic dose AC. A subsequent analysis under review of a larger 4400 patient cohort with longer follow up demonstrated similar associations with reduction in the risk of mortality and risk of intubation. Further analyses suggest more pronounced benefit with therapeutic as opposed to prophylactic doses. Bleeding rates were generally low overall, but higher among patients on therapeutic anticoagulation. Finally, though exploratory in nature, a potential signal for benefit was observed for patients on novel oral anticoagulant therapy (primarily apixaban) at therapeutic doses compared to low molecular weight heparin. Ultimately, randomized controlled trials are needed to elucidate the optimal anticoagulation regimen to improve outcomes in patients hospitalized with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study participants will be randomized in a 1:1:1 fashion to 1 of 3 arms: 1. Prophylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl <30 mL/min) 2. Full-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl <30 mL/min) 3. Apixaban (5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL)
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Enoxaparin | Active comparator | Drug: EnoxaparinProphylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl <30 mL/min) |
| Full Dose Enoxaparin | Active comparator | Drug: EnoxaparinFull-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl <30 mL/min) |
| Apixaban | Experimental | Drug: ApixabanApixaban (5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalization within the prior 24 hours for either confirmed (based on PCR or antigen positive test for SARS-CoV-2) or suspected COVID-19 based on 3 criteria (all 3 must be present for suspected cases):
- Patient or legal guardian provides written informed consent
Key exclusion criteria (28 listed)
- Age <18 years
- Mechanical ventilation on admission or high likelihood for the need for invasive mechanical ventilation within 24 hours of admission
- Anticipated duration of hospital stay <72 hours
- Treatment with therapeutic dose UFH or LMWH, vitamin K antagonists, or NOACs within seven days
- Active bleeding
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 |
|---|---|---|
| EnoxaparinProphylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl <30 mL/min) Full-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl <30 mL/min) | Drug | Full Dose Enoxaparin, Prophylactic Enoxaparin |
| Apixaban(5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL) | Drug | Apixaban |
Primary outcome
Time to first event
Time frame: 30 days
The time to first event rate within 30 days of randomization of the composite of all-cause mortality, intubation requiring mechanical ventilation, systemic thromboembolism (including pulmonary emboli) confirmed by imaging or requiring surgical intervention OR ischemic stroke confirmed by imaging.
Number of in-hospital rate of BARC 3 or 5
Time frame: 30 days
Number of in-hospital rate of BARC 3 or 5 bleeding (binary). BARC Type 3: a. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding b. Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. BARC Type 5: 1. Probable fatal bleeding 2. Definite fatal bleeding (overt or autopsy or imaging confirmation)
16 secondary outcomes
Number of participants with Myocardial infarction
Time frame: 30 days after randomization
Number of participants with Myocardial infarction
Time frame: 90 days after randomization
Number of participants with Deep Vein Thrombosis
Time frame: 30 days after randomization
Number of participants with Deep Vein Thrombosis
Time frame: 90 days after randomization
Number of participants requiring Ventilation
Time frame: 30 after randomization
Number of participants requiring Ventilation
Time frame: 90 days after randomization
Number of All Death
Time frame: 30 days after randomization
Number of All Death
Time frame: 90 days after randomization
Cause of Death
Time frame: 30 days after randomization
Cause of Death
Time frame: 90 days after randomization
Number of participants with Stroke
Time frame: 30 days after randomization
Number of participants with Stroke
Time frame: 90 days after randomization
Number of participants with Pulmonary Emboli
Time frame: 30 days after randomization
Number of participants with Pulmonary Emboli
Time frame: 90 days after randomization
Number of participants with Systemic Thromboembolism
Time frame: 30 days after randomization
Number of participants with Systemic Thromboembolism
Time frame: 90 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 36889611Stone GW, Farkouh ME, Lala A, Tinuoye E, Dressler O, Moreno PR, Palacios IF, Goodman SG, Esper RB, Abizaid A, Varade D, Betancur JF, Ricalde A, Payro G, Castellano JM, Hung IFN, Nadkarni GN, Giustino G, Godoy LC, Feinman J, Camaj A, Bienstock SW, Furtado RHM, Granada C, Bustamante J, Peyra C, Contreras J, Owen R, Bhatt DL, Pocock SJ, Fuster V; FREEDOM COVID Anticoagulation Strategy Randomized Trial Investigators. Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19. J Am Coll Cardiol. 2023 May 9;81(18):1747-1762. doi: 10.1016/j.jacc.2023.02.041. Epub 2023 Mar 6.
- Derived from this study: PubMed 35241226Farkouh ME, Stone GW, Lala A, Bagiella E, Moreno PR, Nadkarni GN, Ben-Yehuda O, Granada JF, Dressler O, Tinuoye EO, Granada C, Bustamante J, Peyra C, Godoy LC, Palacios IF, Fuster V. Anticoagulation in Patients With COVID-19: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Mar 8;79(9):917-928. doi: 10.1016/j.jacc.2021.12.023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
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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.
Valentin Fuster, MD,PhD principal investigator
Icahn School of Medicine at Mount Sinai
Anu Lala, MD principal investigator
Icahn School of Medicine at Mount Sinai
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin and Apixaban in people with COVID-19 and SARS-CoV-2, run by Valentin Fuster at 21 sites in 5 countries.
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 6 inclusion and 28 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in India, Colombia, Mexico, Brazil, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first event (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT04512079, which also lists 2 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 16 Mar 2023.