|
NCT04408235
|
High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy |
Not yet recruiting |
Phase 3 |
Jun/01/2020 |
Jun/01/2021 |
- Alternative id - EudraCT N°: 2020-001972-13
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Azienda Ospedaliero-Universitaria, Modena, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment
- Enrollment - 300
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first:|Any of the following events occurring within the hospital stay|Mortality at 30 days
|
|
NCT04646655
|
Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19 |
Recruiting |
Phase 3 |
Jul/27/2020 |
Feb/28/2023 |
- Alternative id - HLS-02COVID19/2020
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - ASST Fatebenefratelli Sacco, Milan, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 300
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Mortality rate|Progression of respiratory failure|Number of major bleeding episodes|Respiratory function improvement|Number of major cardiovascular events|Deep Vein Thrombosis
|
|
NCT04359277
|
A Randomized Trial of Anticoagulation Strategies in COVID-19 |
Terminated |
Phase 3 |
Apr/21/2020 |
Sep/20/2020 |
- Alternative id - s20-00479
- Interventions - Drug: Enoxaparin Higher Dose|Drug: Lower-dose prophylactic anticoagulation
- Study type - Interventional
- Study results - No Results Available
- Locations - NYU Langone Health, New York, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 77
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Composite incidence of: all-cause mortality, cardiac arrest, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, stroke, or shock|Score on WHO Ordinal Scale|Incidence of acute kidney injury (KDIGO criteria for Acute Kidney Injury (AKI))|Requirement of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)|Cardiac injury|Hypercoagulability|Disseminated Intravascular Coagulation (DIC) Score|Length of Hospital Stay
|
|
NCT04483960
|
Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial |
Recruiting |
Phase 3 |
Jul/28/2020 |
Dec/31/2022 |
- Alternative id - ERM 62646-A
- Interventions - Drug: Nafamostat Mesilate|Biological: Hyperimmune Globulin|Drug: Enoxaparin|Drug: Dalteparin|Drug: Tinzaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Calvary Public Bruce Hospital, Bruce, Australian Capital Territory, Australia|The Canberra Hospital, Canberra, Australian Capital Territory, Australia|Armidale Hospital, Armidale, New South Wales, Australia|Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia|Blacktown Hospital, Blacktown, New South Wales, Australia|Campbelltown Hospital, Campbelltown, New South Wales, Australia|Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia|The Sutherland Hospital, Caringbah, New South Wales, Australia|Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia|St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia|Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia|Griffith Base Hospital, Griffith, New South Wales, Australia|Hornsby Ku-Ring Gai Hospital, Hornsby, New South Wales, Australia|Nepean Hospital, Kingswood, New South Wales, Australia|St George Hospital, Kogarah, New South Wales, Australia|Liverpool Hospital, Liverpool, New South Wales, Australia|John Hunter Hospital, New Lambton Heights, New South Wales, Australia|Orange Health Service, Orange, New South Wales, Australia|Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia|Prince of Wales Hospital, Randwick, New South Wales, Australia|Royal North Shore Hospital, St Leonards, New South Wales, Australia|The Tweed Hospital, Tweed Heads, New South Wales, Australia|Wagga Wagga Base Hospital, Wagga Wagga, New South Wales, Australia|Calvary Mater Newcastle, Waratah, New South Wales, Australia|Westmead Hospital, Westmead, New South Wales, Australia|Wollongong Hospital, Wollongong, New South Wales, Australia|Royal Darwin Hospital, Tiwi, Northern Territory, Australia|Sunshine Coast University Hospital, Birtinya, Queensland, Australia|The Prince Charles Hospital, Chermside, Queensland, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, Australia|Gold Coast University Hospital, Southport, Queensland, Australia|Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia|Royal Hobart Hospital, Hobart, Tasmania, Australia|Launceston General Hospital, Launceston, Tasmania, Australia|Ballarat Health Services, Ballarat Central, Victoria, Australia|St John of God Ballarat Hospital, Ballarat, Victoria, Australia|Bendigo Health, Bendigo, Victoria, Australia|Eastern Health (Box Hill Hospital), Box Hill, Victoria, Australia|Monash Health, Clayton, Victoria, Australia|Northern Health, Epping, Victoria, Australia|St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia|Frankston Hospital - Penninsula Health, Frankston, Victoria, Australia|Peninsula Private Hospital, Frankston, Victoria, Australia|Barwon Health - University Hospital Geelong, Geelong, Victoria, Australia|Austin Health, Heidelberg, Victoria, Australia|Cabrini Health, Malvern, Victoria, Australia|Alfred Hospital, Melbourne, Victoria, Australia|Royal Melbourne Hospital, Parkville, Victoria, Australia|Epworth Richmond, Richmond, Victoria, Australia|Goulburn Valley Health, Shepparton, Victoria, Australia|Western Health, St Albans, Victoria, Australia|Latrobe Regional Hospital, Traralgon, Victoria, Australia|West Gippsland Hospital, Warragul, Victoria, Australia|Albury Wodonga Health, Wodonga, Victoria, Australia|Rockingham General Hospital, Cooloongup, Western Australia, Australia|Joondalup Health Campus, Joondalup, Western Australia, Australia|Armadale Health Service, Mount Nasura, Western Australia, Australia|Fiona Stanley Hospita, Murdoch, Western Australia, Australia|Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia|Royal Perth Hospital, Perth, Western Australia, Australia|St John of God Subiaco Hospital, Subiaco, Western Australia, Australia
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2400
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support.|Time to clinical recovery|WHO 8-point ordinal outcome scale|All-cause mortality|Days alive and free of hospital|Days alive and free of invasive or non-invasive ventilation|Shortness of breath|Quality of life|Antiviral domain-specific outcome: Viral clearance|Antiviral domain-specific outcome: Viral load|Antiviral domain-specific outcome: Safety (Liver enzymes)|Antiviral domain-specific outcome: Safety (potassium)|Antiviral domain-specific outcome: Safety (sodium)|Antiviral domain-specific outcome: Safety (bleeding)|Antiviral domain-specific outcome: Safety (thrombophlebitis)|Antiviral domain-specific outcome: serious adverse reactions|Antibody domain-specific outcome: Serious treatment-related adverse events|Antibody domain-specific outcome: Haemolysis|Antibody domain-specific outcome: Confirmed arterial thrombosis|Antibody domain-specific outcome: Confirmed venous thrombosis|Anticoagulation domain-specific outcome: Confirmed deep venous thrombosis|Anticoagulation domain-specific outcome: Confirmed pulmonary embolus|Anticoagulation domain-specific outcome: Confirmed acute myocardial infarction|Anticoagulation domain-specific outcome: Confirmed ischemic cerebrovascular event|Anticoagulation domain-specific outcome: Major bleeding|Anticoagulation domain-specific outcome: Clinically relevant non-major bleeding|Anticoagulation domain-specific outcome: Heparin-induced thrombocytopenia (HIT)|Anticoagulation domain-specific outcome: Other confirmed thrombotic event
|
|
NCT04366960
|
Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients |
Completed |
Phase 3 |
May/14/2020 |
May/25/2021 |
- Alternative id - 2020-001708-41
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 189
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of venous thromboembolism detected by imaging|In hospital major complications|Number of deep venous thrombosis events|Sequential organ failure assessment|C-reactive protein|Interleukin-6|D-dimer|hs-troponin levels|Acute Respiratory Distress Syndrome|Hospital stay|Right ventricular function|Number of pulmonary embolism events
|
|
NCT04640181
|
Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT) |
Completed |
Phase 2 |
Dec/01/2020 |
Jun/28/2021 |
- Alternative id - 2020-001708-41
- Interventions - Drug: Enoxaparin|Drug: Rivaroxaban
- Study type - Interventional
- Study results - No Results Available
- Locations - St. David's Medical Center, Austin, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Death or 30-day all cause mortality|Mechanical ventilation, intubation|Transfer to an ICU setting|New requirement for hemodialysis (HD) or continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO)|New thrombotic events|Major bleeding event|Time to recovery (defined as no limitation or minor limitation in activity level or hospitalized but require no oxygen)
|
|
NCT04394377
|
Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial |
Completed |
Phase 4 |
Jun/21/2020 |
May/30/2021 |
- Alternative id - 002/2020
- Interventions - Drug: Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed|Drug: Group 2: control group with enoxaparin 40mg/d
- Study type - Interventional
- Study results - No Results Available
- Locations - Centro de Estudos Clínicos do Hospital Cárdio Pulmonar, Salvador, Bahia, Brazil|Instituto de Ensino e Pesquisa do Hospital da Bahia, Salvador, Bahia, Brazil|Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel, Salvador, Bahia, Brazil|Hospital Maternidade São Vicente de Paulo, Barbalha, Ceará, Brazil|Centro de Ensino e Aperfeiçoamento em Pesquisa - CEAP, Serra, Espirito Santo, Brazil|Centro de Pesquisas Cardiológicas de Goiânia do Hospital das Clínicas (UFG), Goiânia, Goiás, Brazil|Hospital Vera Cruz, Belo Horizonte, Minas Gerais, Brazil|Núcleo de Ciências de Saúde - Unidade de Pesquisa - Hospital Felício Rocho, Belo Horizonte, Minas Gerais, Brazil|Centro de Pesquisa Clínica do Hospital de Clínicas da Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil|Hospital Universitário da Universidade Estadual de Londrina, Londrina, Paraná, Brazil|Hospital Agamenon Magalhães, Recife, Pernambuco, Brazil|Real Hospital Português de Beneficência em Pernambuco, Recife, Pernambuco, Brazil|Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil|Hospital Nereu Ramos, Florianópolis, Santa Catarina, Brazil|Instituto Baia Sul de Ensino E Pesquisa Dr. Irineu May Brodbeck / Hospital Baía Sul, Florianópolis, Santa Catarina, Brazil|Hospital Regional Hans Dieter Schmidt, Joinville, Santa Catarina, Brazil|Hospital de Amor de Barretos - (Pio XII), Barretos, São Paulo, Brazil|Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - Unesp, Botucatu, São Paulo, Brazil|Hospital Universitário São Francisco de Assis, Bragança Paulista, São Paulo, Brazil|Hospital Regional do Litoral Norte, Caraguatatuba, São Paulo, Brazil|Hospital Regional de Registro, Registro, São Paulo, Brazil|Praxis Pesquisa Médica, Santo André, São Paulo, Brazil|Centro Integrado de Pesquisa (CIP) - Hospital de Base de Rio Preto, São José Do Rio Preto, São Paulo, Brazil|Hospital Regional de São José dos Campos, São José Dos Campos, São Paulo, Brazil|Santa Casa de Misericórdia de Votuporanga, Votuporanga, São Paulo, Brazil|Hospital Naval Marcílio Dias, Rio de Janeiro, Brazil|BP - A Beneficência Portuguesa de São Paulo, São Paulo, Brazil|Hcor - Hospital do Coração, São Paulo, Brazil|Hospital Israelita Albert Einstein, São Paulo, Brazil|Hospital Moriah, São Paulo, Brazil|Hospital Samaritano Paulista, São Paulo, Brazil|Hospital Santa Paula, São Paulo, Brazil|Hospital São Paulo, São Paulo, Brazil|Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil|Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo, São Paulo, Brazil|Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP, São Paulo, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 615
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.|Incidence of Venous thromboembolism|Incidence of acute myocardial infarction|Incidence of stroke|Number of days using oxygen therapy|Peak of troponin|Peak of D-dimer|Incidence of Major bleeding and clinically relevant non-major bleeding by the ISTH criteria
|
|
NCT04401293
|
Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients |
Completed |
Phase 3 |
Apr/26/2020 |
May/14/2021 |
- Alternative id - 20-0340
- Interventions - Drug: Enoxaparin|Drug: Prophylactic/Intermediate Dose Enoxaparin
- Study type - Interventional
- Study results - Has Results
- Locations - Beth Israel Newark, Newark, New Jersey, United States|Southside Hospital, Bay Shore, New York, United States|Huntington Hospital, Huntington, New York, United States|Lenox Hill Hospital, New York, New York, United States|Long Island Jewish Medical Center, Queens, New York, United States|Staten Island University Hospital, Staten Island, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 257
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days.|Major Bleeding|Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4|Sepsis-induced Coagulopathy (SIC) Score|Progression to Acute Respiratory Distress Syndrome (ARDS)|Need for Intubation|Re-hospitalization
|
|
NCT04345848
|
Preventing COVID-19 Complications With Low- and High-dose Anticoagulation |
Terminated |
Phase 3 |
Apr/28/2020 |
Jun/02/2021 |
- Alternative id - 2020-00794
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Geneva University Hospitals, Geneva, Switzerland|Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland|Ospedale Regionale di Locarno, Locarno, Switzerland|Hôpital du Valais, Sion, Switzerland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 160
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality|Arterial thrombosis|Venous thromboembolism|Disseminated intravascular coagulation|All-cause mortality|Sepsis-induced coagulopathy|Acute respiratory distress syndrome|Durations of hospital stay, ICU stay, ventilation|Sequential organ failure assessment score|Clinical deterioration
|
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NCT04508439
|
Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection |
Recruiting |
Not Applicable |
Jun/20/2020 |
Dec/30/2020 |
- Alternative id - NR-CEI-HRAEI-19-2020
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Regional de Alta Especialidad de Ixtapaluca, Mexico City, Ixtapaluca, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
- Enrollment - 130
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - low molecular weight heparin (enoxaparin) and ventilatory support time|thrombotic complications and Rivaroxaban|low molecular weight heparin (enoxaparin) and length of hospital stay|low molecular weight heparin (enoxaparin) and mortality rate
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NCT04530578
|
Nebulized Heparin in Severe Acute Respiratory Syndrome COVID-19 |
Recruiting |
Phase 4 |
Jun/01/2020 |
Jun/01/2021 |
- Alternative id - CSanCamilo
- Interventions - Drug: Heparin sodium|Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Clinica San Camilo, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 200
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Percentage of patients requirement mechanical ventilation|Percentage of patients with PaO2 to Fi02 ratio > 300|Lengths of hospital-stay|Mortality rate
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NCT04528888
|
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection |
Recruiting |
Phase 3 |
Nov/25/2020 |
Jul/30/2021 |
- Alternative id - Staunch-19-1.1-26-04-20
- Interventions - Drug: Enoxaparin|Drug: Methylprednisolone|Drug: unfractionated heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - ICU- University Hospital Modena, Modena, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 210
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - All-cause mortality at day 28|All-cause mortality at ICU discharge|All-cause mortality at hospital discharge|Need of rescue administration of high-dose steroids or immune-modulatory drugs|New organ dysfunction during ICU stay|Grade of organ dysfunction during ICU stay|ICU free days at day 28|Occurrence of new infections|Ventilation free days at day 28|Vasopressors free-days at day 28|Switch from non-invasive to invasive mechanical ventilation|Delay from start of non-invasive ventilation to switch to invasive ventilation|Occurrence of protocol related adverse events|Occurrence of venous thromboembolism, stroke or myocardial infarction|Occurrence of major bleeding (safety end point)|Occurrence of clinically relevant non-major bleeding (safety end point)
|
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NCT04512079
|
FREEDOM COVID-19 Anticoagulation Strategy |
Recruiting |
Phase 4 |
Sep/08/2020 |
Jul/01/2022 |
- Alternative id - GCO 20-2115
- Interventions - Drug: Enoxaparin|Drug: Apixaban
- Study type - Interventional
- Study results - No Results Available
- Locations - Icahn School of Medicine at Mount Sinai, New York, New York, United States|Instituto do Coração - INCOR, São Paulo, Brazil|Instituto Prevent Senior - IPS, São Paulo, Brazil|Clínica de la Costa, Barranquilla, Colombia|Clínica Shaio, Bogotá, Colombia|Fundación Cardioinfantil, Bogotá, Colombia|Fundacion Oftalmológica de Santander - Foscal, Bucaramanga, Colombia|Centro Médico Imbanaco, Cali, Colombia|CardioVid, Medellín, Colombia|Eternal Heart Care Centre and Research Ins Pvt Ltd., Jaipur, India|Jaipur National University, Jaipur, India|Sawai Mann Singh Hospital, Jaipur, India|Jaslok Hospital & Research Center, Mumbai, India|Saifee Hospital, Mumbai, India|Sengupta Hospital & Research Institute, Nagpur, India|D Y Patil University School of Medicine & D Y Patil Hospital, Navi Mumbai, India|Hospital Cardiológica Aguascalientes, Aguascalientes, Mexico|Centro Médico Nacional 20 de Noviembre, Mexico City, Mexico|Christus Muguerza Hospital Alta Especialidad, Monterrey, Mexico|Centro de Estudios Clinicos de Querétaro S.C., Santiago de Querétaro, Mexico|Centro Medico Hospital del Prado, Tijuana, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 3600
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to first event|Number of in-hospital rate of BARC 3 or 5|Number of participants with Myocardial infarction|Number of participants with Deep Vein Thrombosis|Number of participants requiring Ventilation|Number of All Death|Cause of Death|Number of participants with Stroke|Number of participants with Pulmonary Emboli|Number of participants with Systemic Thromboembolism
|
|
NCT04520620
|
Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention |
Withdrawn |
Phase 4 |
May/02/2020 |
Jul/10/2020 |
- Alternative id - 20CH089|2020-001823-15
- Interventions - Drug: Lovenox 40 MG in 0.4 mL Prefilled Syringe|Device: Ultrasound of the lower limbs
- Study type - Interventional
- Study results - No Results Available
- Locations - Groupement Hospitalier des portes de Province, Montélimar, France|Centre Hospitalier de Roanne, Roanne, France|CHU de Saint-Etienne, Saint-Étienne, France|Clinique Mutualiste, Saint-Étienne, France
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Measure of anti-Xa activity|Analysis of hemorrhagic risk|Venous thromboembolic events|Analysis individual patient characteristics by the biomarker of Kidney function|Analysis individual patient characteristics by the biomarker of inflammation|Analysis individual patient characteristics by the biomarker of coagulation|Demographic characteristics
|
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NCT04492254
|
Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients |
Recruiting |
Phase 3 |
Sep/15/2020 |
Sep/01/2021 |
- Alternative id - TRI-08892|2020-003125-39
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Harry Gibbs, National Co-ordinating Investigator, The Alfred Hospital, Melbourne, Australia|Dr Frank Cools, National Co-ordinating Investigator, AZ Klina, Brasschaat, Belgium|Prof. Barry Jacobson, National Coordinating Investigator, University of the Witwatersrand, Johannesburg, South Africa
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1370
- Age - 55 Years and older (Adult, Older Adult)
- Outcome measures - Hospital Admission|Death|Bleeding (as defined by ISTH criteria)|Diagnosis of VTE
|
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NCT04486508
|
Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19 |
Completed |
Phase 3 |
Jul/30/2020 |
Jul/05/2021 |
- Alternative id - 99060
- Interventions - Drug: intermediate dose Enoxaparin/ unfractionated heparin|Drug: standard prophylactic dose Enoxaparin/ unfractionated heparin|Drug: Atorvastatin 20mg|Drug: Matched placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Masih Daneshvari Hospital, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 600
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - a composite of acute VTE, arterial thrombosis, treatment with ECMO, or all-cause mortality|Rate of all-cause mortality|Rate of objectively-confirmed VTE|Ventilator free days|Rate of major bleeding|Rate of clinically-relevant non-major bleeding|Rate of severe thrombocytopenia|Rate of rise in liver enzymes|Clinically-diagnosed myopathy|Objectively-confirmed arterial thrombosis
|
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NCT04406389
|
Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) |
Recruiting |
Phase 4 |
Oct/13/2020 |
Dec/01/2022 |
- Alternative id - 20-04021936
- Interventions - Drug: Enoxaparin sodium|Drug: Unfractionated heparin|Drug: Fondapariniux|Drug: Argatroban
- Study type - Interventional
- Study results - No Results Available
- Locations - Weill Cornell Medicine, New York, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 186
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - 30-day mortality|Length of Intensive Care Unit (ICU) Stay in Days|Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events|Number of major and clinically relevant non-major bleeding events
|
|
NCT04367831
|
Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19 |
Completed |
Phase 4 |
May/02/2020 |
May/12/2021 |
- Alternative id - AAAS8980
- Interventions - Drug: Enoxaparin Prophylactic Dose|Drug: Heparin Infusion|Drug: Heparin SC|Drug: Enoxaparin/Lovenox Intermediate Dose
- Study type - Interventional
- Study results - No Results Available
- Locations - Columbia University Medical Center, New York, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 94
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Total Number of Patients with Clinically Relevant Venous or Arterial Thrombotic Events in ICU|Total Number of Patients with In hospital Clinically Relevant Venous or Arterial Thrombotic Events|ICU Length of Stay|Total Number of Patients with the Need for Renal Replacement Therapy in the ICU|Total Number of Patients with Major bleeding in the ICU|Hospital Length of Stay
|
|
NCT04377997
|
Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19 |
Recruiting |
Phase 2 |
May/15/2020 |
Jun/01/2022 |
- Alternative id - 2020P001136
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Abdurahman Khalil, Boston, Massachusetts, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 300
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of patients with the composite efficacy endpoint of death, cardiac arrest, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, or hemodynamic shock.|Number of patients with a major bleeding event according to the International Society on Thrombosis and Haemostasis (ISTH) definition.
|
|
NCT04736901
|
Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19 |
Recruiting |
|
Dec/01/2020 |
Jun/01/2021 |
- Alternative id - COVID-Anticoagulants
- Interventions - Drug: Enoxaparin|Drug: Rivaroxaban|Drug: Apixaban
- Study type - Observational
- Study results - No Results Available
- Locations - Teachers Hospital, Cairo, Please Select, Egypt
- Study designs - Observational Model: Cohort|Time Perspective: Other
- Enrollment - 90
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Change in clotting factors level|Change in gas exchange over time|Time to increase in oxygenation|Duration of hospitalization|Monitoring of adverse events|In hospital mortality rate|Monitoring of hemoglobin levels.|Monitoring of platelets levels
|
|
NCT04425863
|
Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19 |
Completed |
|
May/01/2020 |
Aug/30/2020 |
- Alternative id - IDEA
- Interventions - Drug: Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets|Other: Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets|Other: Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU.
- Study type - Observational
- Study results - Has Results
- Locations - Hospital Eurnekian, Buenos Aires, Argentina
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 167
- Age - 5 Years and older (Child, Adult, Older Adult)
- Outcome measures - Patients Who Improved Their Condition or Did Not Worsen it|ICU-treated Patients After 2-week Treatment|Mortality|Patients Needing Drug Dose Adjustment|Adverse Events
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NCT04427098
|
Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients |
Recruiting |
Phase 2 |
May/22/2020 |
Oct/30/2020 |
- Alternative id - 2020-001308-40
- Interventions - Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution|Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Policlinico S. Orsola Malpighi Dipartimento Malattie Infettive, Bologna, Emilia Romagna, Italy|Azienda Ospedaliero-Universitaria di Parma Anestesia e Rianimazione Dipartimento di Medicina e Chirurgia, Parma, Emilia Romagna, Italy|I.R.C.C.S. "Casa Sollievo della Sofferenza", San Giovanni Rotondo (FG) UOVD Emostasi e trombosi- Poliambulatorio Giovanni Paolo II Viale Padre Pio n.7 San Giovanni Rotondo (FG), San Giovanni Rotondo, Foggia, Italy|Fondazione Poliambulanza Chirurgia Vascolare, Brescia, Italy|Piazzale Spedali Civili, 1, 25123 Brescia BS Medicina Interna UniBS 2° Medicina ASST Spedali Civili, Brescia, Italy|Azienda Ospedaliero-Universitaria "Policlinico - V. Emanuele", Catania Anestesia e Rianimazione UO Malattie Infettive, Catania, Italy|ASST Cremona Unità Operativa di Chirurgia Vascolare Dipartimento di Medicina di Laboratorio e di Radiologia- Centro Emostasi e Trombosi, Cremona, Italy|Ospedale Morgagni Pierantoni U.O.C. Malattie Infettive, Forlì, Italy|Ospedale Carlo Poma di Mantova MALATTIE INFETTIVE Padiglione 37 Str. Lago Paiolo, 10, 46100 Mantova, Mantova, Italy|AZIENDA OSPEDALIERA Regionale S CARLO POTENZA Struttura Complessa Interaziendale "Malattie Infettive", Matera, Italy|Ospedale San Raffaele Unità Funzionale dell'Unità Operativa di Malattie Infettive Osp. San Raffaele, Milano, Italy|Ospedale Amedeo di Savoia Torino Università di Torino Malattie Infettive, Torino, Italy|Azienda Ospedaliera Universitaria Integrata Verona UOC Malattie Infettive e Tropicali, Verona, Italy
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 300
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.|To analyse the safety of enoxaparin in hospitalized patients with moderatesevere COVID-19.|To describe the rates and the types of thromboembolic events among hospitalized patients with confirmed diagnosis of COVID-19.
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NCT04373707
|
Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19 |
Completed |
Phase 4 |
May/13/2020 |
Sep/14/2021 |
- Alternative id - 2020-001709-21
- Interventions - Drug: Enoxaparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Amiens Academic Hospital, Amiens, France|Besançon Academic Hospital, Besançon, France|Brest Academic Hospital, Brest, France|Civil Hospital, Colmar, France|Dijon Academic Hospital, Dijon, France|Kremlin Bicêtre Academic Hospital, Le Kremlin-Bicêtre, France|Lille Academic Hospital, Lille, France|Groupe Hospitalier Unéos, Metz, France|Metz-Thionville Regional Hospital, Metz, France|Montpellier Academic Hospital, Montpellier, France|Emile Muller Hospital, Mulhouse, France|Nancy Academic Hospital, Nancy, France|George Pompidou European Hospital, Paris, France|Lariboisière Academic Hospital, Paris, France|St Etienne Academic Hospital, Saint-Étienne, France|Strasbourg Academic Hospital, Strasbourg, France|Toulouse Academic Hospital, Toulouse, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 1000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Venous thromboembolism|Major bleeding|Major Bleeding and Clinically Relevant Non-Major Bleeding|Net Clinical Benefit|Venous Thromboembolism at other sites|Arterial Thrombosis|All-Cause Mortality|Factors associated with the risk of venous thromboembolism
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NCT05226793
|
Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients |
Recruiting |
|
Nov/17/2021 |
Nov/17/2023 |
- Alternative id - 054.PHA.2021.R
- Interventions -
- Study type - Observational
- Study results - No Results Available
- Locations - Methodist Richardson Medical Center, Richardson, Texas, United States
- Study designs - Observational Model: Case-Only|Time Perspective: Retrospective
- Enrollment - 400
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Enoxaparin dose (appropriate for kidney function)|Charlson comorbidity index (CCI) score|Padua prediction score for risk of VTE|IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score|ICU status|Number of thromboembolic events|Length of stay|Readmissions for DVT and/or PE|In-hospital mortality with associated DVT or PE|Bleeding events|Type of bleeding event
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NCT04400799
|
Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19 |
Recruiting |
Phase 3 |
Jun/15/2020 |
Apr/14/2022 |
- Alternative id - OVID Trial
- Interventions - Drug: Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml
- Study type - Interventional
- Study results - No Results Available
- Locations - Universitätsklinikum Freiburg, Freiburg, Germany|Johannes Gutenberg-Universität Mainz, Mainz, Germany|University Hospital Basel, Basel, Switzerland|Clinic of Hematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland|University Hospital Bern, Bern, Switzerland|Hôpitaux Universitaires Genève, Geneva, Switzerland|Centre hospitalier universitaire vaudois, Lausanne, Switzerland|Clinica Luganese Moncucco, Lugano, Switzerland|University Hospital Zurich, Zürich, Switzerland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1000
- Age - 50 Years and older (Adult, Older Adult)
- Outcome measures - hospitalizations|all-cause death|Number of cardiovascular events|any hospitalizations|Net clinical benefit|Disseminated intravascular coagulation
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NCT05224388
|
Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels. |
Recruiting |
|
Jan/01/2020 |
Mar/30/2022 |
- Alternative id - BC-07991
- Interventions - Drug: Enoxaparin|Drug: Heparin
- Study type - Observational
- Study results - No Results Available
- Locations - Ghent University Hospital, Gent, Belgium
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 800
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Evaluate dose regimen of UFH en LMWH for critically ill patients and Covid-19 patients in: - preventing thrombo-embolic complications - time to reach adequate prophylactic antiXa range|Possible risk factors for thrombo-embolic complications in COVID-19 patients|Safety of increased dose of thromboprophylaxis in Covid-19 patients
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NCT04354155
|
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial |
Completed |
Phase 2 |
Jun/02/2020 |
Jun/04/2021 |
- Alternative id - COVAC-TP
- Interventions - Drug: Enoxaparin Prefilled Syringe [Lovenox]
- Study type - Interventional
- Study results - No Results Available
- Locations - Children's of Alabama, Birmingham, Alabama, United States|Children's Hospital Los Angeles, Los Angeles, California, United States|Hemostasis and Thrombosis Center UC Davis, Sacramento, California, United States|Rady Children's Hospital, San Diego, California, United States|Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States|Children's Hospital of Atlanta, Atlanta, Georgia, United States|Lurie Children's Hospital, Chicago, Illinois, United States|Rush University Medical Center, Chicago, Illinois, United States|Children's Hospital New Orleans, New Orleans, Louisiana, United States|Johns Hopkins Hospital and Children's Center, Baltimore, Maryland, United States|Boston Children's Hospital, Boston, Massachusetts, United States|Children's Hospital of Michigan, Detroit, Michigan, United States|Cohen Children's Medical Center, New Hyde Park, New York, United States|Akron Children's Hospital, Akron, Ohio, United States|Children's Hospital Pittsburgh, Pittsburgh, Pennsylvania, United States|Children's Medical Center of Dallas, Dallas, Texas, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 40
- Age - up to 18 Years (Child, Adult)
- Outcome measures - Safety of in-hospital thromboprophylaxis|Median twice-daily enoxaparin dose
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NCT04558125
|
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism |
Terminated |
Phase 4 |
Sep/08/2020 |
Aug/08/2021 |
- Alternative id - ML42522
- Interventions - Drug: TNKase|Drug: Placebo|Drug: Enoxaparin
- Study type - Interventional
- Study results - Has Results
- Locations - Cedars-Sinai Medical Center, Los Angeles, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 2
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Percent Improvement in Shock Index (Defined as Heart Rate Divided by Systolic Blood Pressure) 6 Hours After the TNK/Placebo Bolus.|1. Clinical Status at 24 Hours After Administration of TNK / Placebo Based Upon 7-point Scale.
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NCT04409834
|
Prevention of Arteriovenous Thrombotic Events in Critically-Ill COVID-19 Patients Trial |
Recruiting |
Phase 4 |
Aug/05/2020 |
Mar/01/2022 |
- Alternative id - CCCTN/TIMI COVID-PACT
- Interventions - Drug: Unfractionated Heparin IV|Drug: Enoxaparin 1 mg/kg|Drug: Clopidogrel|Drug: Unfractionated heparin SC|Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution
- Study type - Interventional
- Study results - No Results Available
- Locations - Brigham and Women's Hospital, Boston, Massachusetts, United States
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 750
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Primary endpoint: Venous or arterial thrombotic events|Key secondary endpoint: Clinically evident venous or arterial thrombotic events
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NCT05185804
|
Clinical Trial of Dimolegin (DD217) in Prevention of Thrombotic Complications in Patients With COVID-19 |
Completed |
Phase 3 |
Feb/08/2021 |
Oct/29/2021 |
- Alternative id - АМ217-03
- Interventions - Drug: Dimolegin|Drug: Clexane
- Study type - Interventional
- Study results - No Results Available
- Locations - Regional budgetary healthcare institution Ivanovskaya clinical hospital named after Kuvaevs, Ivanovo, Russian Federation|State Budgetary Institution of Healthcare Research Institute - Regional Clinical Hospital No. 1 named after Professor S.V. Ochapov Ministry of Health of the Krasnodar Territory, Krasnodar, Russian Federation|Federal State Budgetary Educational Institution of Higher Education Ryazan State Medical University named after academician I.P. Pavlova of the Ministry of Health of the Russian Federation, Ryazan', Russian Federation|State Healthcare Institution Saratov City Clinical Hospital No. 2 named after IN AND. Razumovsky, Saratov, Russian Federation|St. Petersburg State Budgetary Healthcare Institution City Hospital No. 40 of Kurortny District, Sestroretsk, Russian Federation|State budgetary institution of health care of the Yaroslavl region Yaroslavl Regional Clinical Hospital of War Veterans - International Center for the Problems of the Elderly Healthy Longevity, Yaroslavl, Russian Federation
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 399
- Age - 18 Years to 85 Years (Adult, Older Adult)
- Outcome measures - The frequency of DVT|The frequency of PE|The frequency of ischemic stroke|The frequency of AMI|The frequency of arterial thrombotic complication|The proportion of patients transferred to the ICU|The all-cause mortality rate|The all-cause mortality rate during the study|The proportion of patients who stayed in the hospital more than 30 days|The number of days the patient spent in the hospital before discharge due to recovery or positive dynamics, including outpatient follow-up before 30 days expire|Recovery rate|Proportion of patients requiring high-flow oxygen therapy or noninvasive ventilation (NIV)|Changes in the hemostasis system parameters|The efficacy of drugs in patients depends on the D-dimer level at screening
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