NCT05255848
|
Nebulised Heparin in Patients With COVID-19 Pneumonia |
Not yet recruiting |
Phase 2|Phase 3 |
Feb/20/2022 |
Oct/20/2022 |
- Alternative id - 294/LRH/MTI
- Interventions - Drug: Unfractionated heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Pulmonology Department, Lady Reading Hospital, Peshawar, Peshawar, Khyber Pakhtunkhwa, Pakistan
- Study designs - Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 180
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of patients requiring Intubation|Mortality|Oxygenation|Number of patients showing worsening or improvement on the modified WHO ordinal scale.
|
NCT05204550
|
Intranasal Heparin Treatment to Reduce Transmission Among Household Contacts of COVID 19 Positive Adults and Children |
Not yet recruiting |
Phase 2|Phase 3 |
Apr/01/2022 |
Nov/30/2023 |
- Alternative id - 83609
- Interventions - Drug: unfractionated heparin|Drug: 0.9%sodium chloride
- Study type - Interventional
- Study results - No Results Available
- Locations - The Northern Hospital, Epping, Victoria, Australia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 1100
- Age - 5 Years to 100 Years (Child, Adult, Older Adult)
- Outcome measures - Number of household contacts (swab negative on day 1) testing positive for SARS-CoV-2 by PCR on either of three routine nasopharyngeal swabs on day 3,5 and 10 after enrolment or on nasopharyngeal swab in response to clinical symptoms in the first 14 days|Number of household contacts (swab negative on day 1 of study) becoming symptomatic of COVID-19 in next 28 days|total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 3|total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 5|total number of index cases and household contacts (nasopharyngeal swab positive on day 1) combined, who remain swab positive on day 10|Time to swab negative based on daily anterior nasal swab for index cases and household contacts combined who were swab positive on day 1.|Quantitative replication sub genomic viral RNA at days 3 post randomisation.|Quantitative replication sub genomic viral RNA at days 5 post randomisation.|Quantitative replication sub genomic viral RNA at days 10 post randomisation.|The number of participants who discontinue treatment prior to day 10 from randomisation|Number of index cases and household contacts swab positive on day 1, hospitalized with COVID-19 by day 28 from randomization|Number of household contacts swab negative on day 1, hospitalized with COVID-19 by day 28 from randomization|Maximum severity score of participants (index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1) during the study period as recorded by daily symptom diary up to day 28|time to symptom resolution analysis for index case and household contacts swab positive on day 1 compared to household contacts swab negative on day 1, during the study period as measured with daily symptom diary until on day 28|Number of participants with clinical symptoms of neurological long COVID at 6 months post initial positive COVID-19 test.|Number of participants with clinical symptoms of neurological long COVID at 12 months post initial positive COVID-19 test.
|
NCT04402892
|
COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells |
Not yet recruiting |
Not Applicable |
Jun/01/2020 |
Mar/01/2021 |
- Alternative id - APHP200551
- Interventions - Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )|Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 60
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
|
NCT04505774
|
Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE |
Recruiting |
Phase 4 |
Sep/04/2020 |
Dec/01/2022 |
- Alternative id - ACTIV-4 ACUTE|1OT2HL156812-01
- Interventions - Drug: theraputic heparin|Drug: prophylactic heparin|Drug: P2Y12|Drug: Crizanlizumab Injection|Drug: SGLT2 inhibitor
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Alabama, Birmingham, Alabama, United States|University of Arizona, Tucson, Arizona, United States|University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States|Kaiser Permanente Fontana, Fontana, California, United States|Kaiser Permanente Los Angeles, Los Angeles, California, United States|Smidt Heart Institute at Cedars-Sinai, Los Angeles, California, United States|Ronald Reagan UCLA Medical Center, Los Angeles, California, United States|UC San Diego Hillcrest, San Diego, California, United States|Zuckerberg San Francisco General Hospital, San Francisco, California, United States|UCSF San Francisco, San Francisco, California, United States|Zuckerberg San Francisco General Hospital, San Francisco, California, United States|Stanford University Medical Center, Stanford, California, United States|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States|Denver Health and Hospital Authority, Denver, Colorado, United States|St. Mary's Hospital & Regional Medical Center, Grand Junction, Colorado, United States|Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States|University of Florida, Gainesville, Florida, United States|Memorial Hospital, Jacksonville, Florida, United States|AdventHealth Tampa, Tampa, Florida, United States|Emory, Atlanta, Georgia, United States|Morehouse School of Medicine, Atlanta, Georgia, United States|Queens Medical Center, Honolulu, Hawaii, United States|Memorial Hospital, Belleville, Illinois, United States|Cook County Health, Chicago, Illinois, United States|University of Illinois at Chicago Health (UIH), Chicago, Illinois, United States|OSF Little Company of Mary Medical Center (OSF LCM), Evergreen Park, Illinois, United States|Indiana University Health Methodist Hospital, Indianapolis, Iowa, United States|Kansas University Medical Center, Kansas City, Kansas, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, United States|Boston University, Boston, Massachusetts, United States|St Elizabeth's Medical Center, Brighton, Massachusetts, United States|Baystate Medical Center, Springfield, Massachusetts, United States|University of Massachusetts, Worcester, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Wayne State University, Detroit, Michigan, United States|Hennepin County Medical Center, Minneapolis, Minnesota, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Washington University School of Medicine, ACCS Research, Saint Louis, Missouri, United States|University Medical Center of Southern Nevada, Las Vegas, Nevada, United States|Cooper Health, Camden, New Jersey, United States|Englewood Health, Englewood, New Jersey, United States|Atlantic Health System, Morristown, New Jersey, United States|Rutgers New Jersey Medical School, Newark, New Jersey, United States|AtlantiCare Regional Medical Center, Pomona, New Jersey, United States|Albany Medical College, Albany, New York, United States|Jacobi Medical Center, Bronx, New York, United States|Montefiore Medical Center, Bronx, New York, United States|Mercy Hospital Buffalo, Buffalo, New York, United States|VA New York Harbor Healthcare System, New York, New York, United States|NYU Langone, New York, New York, United States|Mt. Sinai Hospital, New York, New York, United States|SUNY Upstate University Hospital, Syracuse, New York, United States|Westchester Medical Center, Valhalla, New York, United States|Duke University Hospital, Durham, North Carolina, United States|Wake Forest, Winston-Salem, North Carolina, United States|Cleveland Clinic Akron General, Akron, Ohio, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, United States|The MetroHealth System, Cleveland, Ohio, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|Ohio State Universtiy Wexner Medical Center, Columbus, Ohio, United States|Mercy Health St Vincent Medical Center, Toledo, Ohio, United States|Ascension St. John Clinical Research Institute, Tulsa, Oklahoma, United States|Oregon Health and Science University, Portland, Oregon, United States|Geisinger Research, Danville, Pennsylvania, United States|Doylestown Cardiology Associates, Doylestown, Pennsylvania, United States|Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|Temple University, Philadelphia, Pennsylvania, United States|UPMC Presbyterian, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital, Providence, Rhode Island, United States|The Miriam Hospital, Providence, Rhode Island, United States|Sarah Cannon and HCA Research Institute, Nashville, Tennessee, United States|Skyline Medical Center, Nashville, Tennessee, United States|University of Texas at Austin, Austin, Texas, United States|University of Texas Southwestern Medical Center, Dallas, Texas, United States|Medical City Ft Worth, Fort Worth, Texas, United States|Baylor Scott and White Medical Center - Temple, Temple, Texas, United States|HCA Henrico Doctors Hospital, Richmond, Virginia, United States|Swedish Hospital, Seattle, Washington, United States|West Virginia University CTR, Morgantown, West Virginia, United States|University of Wisconsin Hospital; Meriter Hospital (UW affiliated), Madison, Wisconsin, United States|Hospital Universitario Sao Francisco de Assis, Braganca Paulista, Brazil|União Brasileira de Educação e Assistência - Hospital São Lucas da PUCRS, Porto Alegre, Brazil|Centro de Estudos Clínicos do Hospital Cárdio Pulmonar, Salvador, Brazil|Fundação Faculdade Regional De Medicina De São José Do Rio Preto, São José do Rio Preto, Brazil|Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil|Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP, São Paulo, Brazil|Azienda Ospedaliero Sant Anna e San Sebastiano, Caserta, Italy|Maria Cecilia Hospital , Cotignola, Ravenna, Cotignola, Italy|Università degli Studi di Ferrara, Ferrara, Ferrara, Italy|Azienda Ospedaliero -Universitaria Careggi, Firenze, Italy|Policlinico di Napoli, Napoli, Napoli, Italy|AOU Policlinico di Palermo, Palermo, Palermo, Italy|ASL-1 Imperiese, Sanremo, Sanremo, Italy|Hospital Universitario A Coruna, A Coruna, Spain|Hospital Virgen del Mar, Almeria, Spain|Hospital Arnau de Vilanova, Lleida, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Universitario Ramon Y Cajal, Madrid, Spain|Hospital Universitario Ramon Y Cajal, Madrid, Spain|Hospital Clínico Universitario de Salamanca, Salamanca, Spain|Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 3000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - 21 Day Organ Support (respiratory or vasopressor) Free Days|Secondary Endpoint all cause mortality|Other Platform Secondary Endpoints of Morbidity and Hospitalization|Days free of death|Death Composite|Acute kidney injury
|
NCT04372589
|
Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC) |
Completed |
Phase 2|Phase 3 |
May/20/2020 |
May/17/2021 |
- Alternative id - ATTACC|OZM-113
- Interventions - Drug: Heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Emory University Hospital Midtown, Atlanta, Georgia, United States|University of Chicago, Chicago, Illinois, United States|Ochsner Clinic, Jefferson, Louisiana, United States|Maine Medical Center, Portland, Maine, United States|Henry Ford University, Dearborn, Michigan, United States|Beaumont Hospital, Royal Oak, Michigan, United States|Mayo Clinic, Rochester, Minnesota, United States|Saint Louis University School of Medicine/Saint Louis Veterans Affairs Medical Center, Saint Louis, Missouri, United States|Cooper University Health Care, Camden, New Jersey, United States|Hackensack University Medical Center, Hackensack, New Jersey, United States|Saint Barnabas Medical Center, Livingston, New Jersey, United States|Montefiore-Einstein Center for Heart and Vascular Care, New York, New York, United States|Vanderbilt University Medical Center, Nashville, Tennessee, United States|Santa Casa de Misericordia de Itabuna, Itabuna, BA, Brazil|Hospital Unimed do Cariri, Juazeiro do Norte, CE, Brazil|Instituto Goiano de Oncologia e Hematologia - INGOH, Goiania, Goias, Brazil|Centro de Pesquisas Clínicas Humap - UFMS, Campo Grande, Mato Grosso Do Sul, Brazil|Hospital Felício Rocho, Belo Horizonte, MG, Brazil|Clinica de Campo Grande S/A, Campo Grande, MS, Brazil|Unimed Campo Grande, Campo Grande, MS, Brazil|Hospital Agamenon Magalhaes, Recife, Pernanbuco, Brazil|Hospital das Clinicas da UFPR, Curitiba, PR, Brazil|Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brazil|Parana Medical Research Center, Maringa, PR, Brazil|Hospital Sao Vicente de Paulo, Passo Fundo, Rio Grande Do Sul, Brazil|Hospital Universitario Pedro Ernesto, Rio de Janeiro, RJ, Brazil|Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil|Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, RS, Brazil|Instituto de Medicina Vascular, Porto Alegre, RS, Brazil|AngioCor Blumenau, Blumenau, Santa Catarina, Brazil|Instituto de Cardiologia de Santa Catarina, Sao Jose, Santa Catarina, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, Sao Paulo, Brazil|Praxis Pesquisa Medica, Santo Andre, Sao Paulo, Brazil|Santa Casa de Votuporanga, Votuporanga, Sao Paulo, Brazil|Casa de Saúde Santa Marcelina, Sao Paulo, SP, Brazil|Instituto de Molestias Cardio Vasculares de Tatui, Tatui, SP, Brazil|Hospital 9 de Julho, São Paulo, Brazil|Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil|Instituto de Infectologia Emilio Ribas, São Paulo, Brazil|Instituto do Coração do Estado de São Paulo, São Paulo, Brazil|Sociedade Beneficente Israelita Hospital Albert Einstein, São Paulo, Brazil|Victoria General Hospital, Victoria, British Columbia, Canada|Health Sciences Center Winnipeg, Winnipeg, Manitoba, Canada|Grace General Hospital, Winnipeg, Manitoba, Canada|St. Boniface General Hospital, Winnipeg, Manitoba, Canada|Hamilton Health Sciences, Hamilton, Ontario, Canada|St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada|Hôpital Montfort, Ottawa, Ontario, Canada|The Ottawa Hospital, Ottawa, Ontario, Canada|University Health Network, Toronto, Ontario, Canada|McGill University Health Centre, Montréal, Quebec, Canada|Centre Hospitalier de l'université de Montréal (CHUM), Montréal, Quebec, Canada|Jewish General Hospital, Montréal, Quebec, Canada|CHU de Quebec-University Laval, Québec, Quebec, Canada|Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ), Québec, Quebec, Canada|Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada|Regina General Hospital, Regina, Saskatchewan, Canada|Hospital de Infectolog´ñia Centro Médico Nacional La Raza, Azcapotzalco, Mexico City, Mexico|Hospital General Regional 1 Carlos MacGregor Sánchez Navarro, Benito Juárez, Mexico City, Mexico|Hospital General regional 2 El Marqués, Querétaro, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality and days free of organ support|Arterial and venous thrombotic conditions|Intubation and mortality|All-cause mortality|Intubation|Hospital-free days|Ventilator-free days|Myocardial infarction|Ischaemic stroke|Venous thromboembolism|Vasopressor-free days|Renal replacement free days|Hospital re-admission|Acute kidney injury|Systemic arterial thrombosis or embolism|ECMO support|Mechanical circuit thrombosis|WHO ordinal scale|Major bleeding|Heparin-induced thrombocytopenia (HIT)
|
NCT04842292
|
Nebulized Heparin for COVID19-associated Acute Respiratory Failure |
Recruiting |
Phase 2 |
May/20/2021 |
Mar/31/2022 |
- Alternative id - 65139
- Interventions - Drug: Heparin|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - UK Healthcare, Lexington, Kentucky, United States
- Study designs - Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Mean PaO2/FiO2 ratio|Clinically Significant Bleeding|Incidence of venous thromboembolism
|
NCT04990830
|
Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia |
Completed |
Phase 2|Phase 3 |
Feb/03/2021 |
May/21/2021 |
- Alternative id - E-66175679-514.03.01-328141|46325
- Interventions - Drug: Inhaled Low molecular weight heparin|Drug: Standard Treatment
- Study type - Interventional
- Study results - No Results Available
- Locations - Istanbul University Medical Faculty, Istanbul, Fatih, Turkey
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 80
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Change in clinical status on a 5-point clinical scale for hypoxemia|Improvement rate of the breathing status|Change in peripheral oxygen saturation (Sp02)|Length of stay|Overall survival
|
NCT04787510
|
COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection |
Completed |
|
Dec/23/2020 |
Jun/23/2021 |
- Alternative id - 895/23-12-2020
- Interventions - Drug: low molecular weight Heparin as standard of care treatment
- Study type - Observational
- Study results - No Results Available
- Locations - University General Hospital of Ioannina, Ioánnina, Epirus, Greece
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 50
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - EFFECT OF COVID-19 DISEASE IN CLOTTING FACTORS
|
NCT04545541
|
Nebulised Heparin in Patients With Severe COVID-19 |
Recruiting |
Phase 2|Phase 3 |
Nov/01/2020 |
Jun/01/2022 |
- Alternative id - CHARTER meta-trial
- Interventions - Drug: Nebulised unfractionated heparin (UFH)
- Study type - Interventional
- Study results - No Results Available
- Locations - Frederick Health Hospital, Frederick, Maryland, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 300
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Alive and Ventilator Free Score
|
NCT04723563
|
Nebulized Heparin for the Treatment of COVID-19 |
Completed |
Phase 4 |
Feb/22/2021 |
Aug/23/2021 |
- Alternative id - FHHep2121
- Interventions - Drug: Heparin|Drug: 0.9%sodium chloride
- Study type - Interventional
- Study results - No Results Available
- Locations - Frederick Health Hospital, Frederick, Maryland, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 50
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Need for mechanical ventilation at day 28|Hospital length of stay|Average daily SaO2/FiO2
|
NCT04393805
|
Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto |
Completed |
|
Jun/01/2020 |
Feb/26/2021 |
- Alternative id - HETHICO
- Interventions - Drug: Low Molecular Weight Heparin
- Study type - Observational
- Study results - No Results Available
- Locations - Giuseppe Camporese, Padova, Italy
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 744
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Bleeding|Thrombosis|Mortality|Worsening|LOS
|
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)
|
NCT04487990
|
CoV-Hep Study: Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19 |
Active, not recruiting |
Not Applicable |
Jun/29/2020 |
Aug/01/2021 |
- Alternative id - U1111-1252-0194|33351120.0.0000.0068
- Interventions - Drug: unfractionated Heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - University of São Paulo General Hospital, São Paulo, SP, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 118
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Clotted dialyzers|Time-free of clotting|Number of dialyzers used|Pressure variation|Urea sieving|Downtime of dialysis
|
NCT05256524
|
Is Anti-Factor Xa Associated With Outcome in Patients With Critical COVID-19 on Low-Molecular-Weight Heparin? |
Completed |
|
Mar/01/2020 |
Aug/29/2021 |
- Alternative id - AntiFactorXa in Covid-19
- Interventions - Drug: The effect of LMWH|Diagnostic Test: Monitoring frequency of aFXa-levels
- Study type - Observational
- Study results - No Results Available
- Locations - Södersjukhuset, Stockholm, Sweden
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 1520
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality|Thromboembolic events|Bleeding events
|
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
|
NCT04466670
|
Hemostasis in COVID-19: an Adaptive Clinical Trial |
Recruiting |
Phase 2 |
Jul/11/2020 |
May/30/2022 |
- Alternative id - 33788820.9.0000.0068
- Interventions - Drug: acetylsalicylic acid|Drug: Unfractionated heparin nebulized
- Study type - Interventional
- Study results - No Results Available
- Locations - Vanderson Rocha, Sao Paulo, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 379
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Hospital discharge - alive / death|Length of mechanical ventilation free days|Length of renal replacement therapy free days|Number of documented venous thromboembolism or arterial thrombosis
|
NCT05184101
|
Inhaled Heparin for Hospitalised Patients With Coronavirus Disease 2019 (COVID-19) |
Not yet recruiting |
Phase 2|Phase 3 |
May/01/2022 |
Apr/01/2023 |
- Alternative id - INHALE-HEP Australia Version 3
- Interventions - Drug: unfractionated Heparin
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Intubation|Mortality|Oxygenation
|
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
|
NCT04542408
|
Hamburg Edoxaban for Anticoagulation in COVID-19 Study |
Recruiting |
Phase 3 |
Nov/12/2020 |
Sep/01/2022 |
- Alternative id - HERO-19
- Interventions - Drug: Anticoagulation Agents (Edoxaban and/or high dose LMWH)|Drug: Low dose Low molecular weight heparin or Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - UK Aachen, Aachen, Germany|Universitätsklinikum Augsburg, Augsburg, Germany|Universitätsklinikum Düsseldorf, Düsseldorf, Germany|Universitätsklinikum Freiburg, Freiburg, Germany|Asklepios Klinik Altona, Hamburg, Germany|Asklepios Klinik Barmbek, Hamburg, Germany|Asklepios Klinik St. Georg, Hamburg, Germany|Universitärsklinikum Hamburg-Eppendorf, Hamburg, Germany|Medizinische Hochschule Hannover, Hanover, Germany|TU München Klinikum rechts der Isar, München, Germany
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 172
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism|All-cause mortality|Mortality related to venous thromboembolism|Mortality related to arterial thromboembolism|Rate of venous and/ or arterial thromboembolism|Rate and length of mechanical ventilation|Length of initial stay at ICU after application of IMP|Rehospitalisation|Rate and length of renal replacement therapy|Cardiac arrest/ CPR
|
NCT04380818
|
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19 |
Recruiting |
Not Applicable |
Jun/05/2020 |
Nov/01/2021 |
- Alternative id - IPACOVID
- Interventions - Radiation: Low-dose radiotherapy|Drug: Hydroxychloroquine Sulfate|Drug: Ritonavir/lopinavir|Drug: Tocilizumab Injection [Actemra]|Drug: Azithromycin|Drug: Corticosteroid|Drug: Low molecular weight heparin|Device: Oxygen supply
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Sant Joan de Reus, Reus, Tarragona, Spain|Hospital Del Mar, Barcelona, Spain|Hospital Universitario Madrid Sanchinarro, Madrid, Spain
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care
- Enrollment - 106
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|Change of the radiological image|Overall mortality|Measure of pro-inflammatory interleukins|Measure of trasforming growth factor (TGF-b)|Measure of tumor necrosis factor alpha (TNF-a)|Determining overexpression of pro-inflammatory selectin|Determining cell adhesion molecules (CAMs)|Measure of marker of oxidative stress PON-1
|
NCT04584580
|
D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia |
Recruiting |
Phase 4 |
Aug/01/2020 |
Dec/31/2020 |
- Alternative id - FMASU P35/ 2020
- Interventions - Drug: low-molecular-weight heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center, Cairo, Non-US, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Supportive Care
- Enrollment - 50
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - mortality|occurrence of venous and/or arterial thrombosis|occurrence of Sepsis-induced coagulopathy|Occurrence of adult respiratory distress syndrome (ARDS)|Occurrence of sepsis|ICU admission and need for mechanical ventilation
|
NCT04397510
|
Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury |
Enrolling by invitation |
Phase 4 |
Jun/01/2020 |
Dec/31/2021 |
- Alternative id - FHHep518
- Interventions - Drug: Heparin|Drug: 0.9% Sodium-chloride
- Study type - Interventional
- Study results - No Results Available
- Locations - Frederick Health Hospital, Frederick, Maryland, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 50
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mean daily PaO2 to FiO2 ratio|Duration of mechanical ventilation|ICU length of stay|Mortality Rate|Incidence of adverse drug events
|
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
|
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)
|
NCT04635241
|
Inhaled Heparin for Hospitalised COVID-19 Patients |
Recruiting |
Phase 2|Phase 3 |
Jun/01/2020 |
Dec/01/2022 |
- Alternative id - INHALE-HEP meta-trial
- Interventions - Drug: Unfractionated heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - San Camilo Clinic, Buenos Aires, Argentina|15th May hospital, Cairo, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 712
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Intubation rate|WHO ordinal scale COVID19|Oxygenation
|
NCT04600141
|
Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection |
Completed |
Phase 3 |
Nov/10/2020 |
Dec/31/2021 |
- Alternative id - HEPMAB
- Interventions - Drug: Tocilizumab|Drug: Heparin - Therapeutic dosage|Drug: Heparin - Prophylactic dosage
- Study type - Interventional
- Study results - No Results Available
- Locations - Fundação São Francisco Xavier, Ipatinga, Minas Gerais, Brazil|UNIMED Varginha, Varginha, Minas Gerais, Brazil|Universidade Federal de Sergipe, Aracaju, Sergipe, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 308
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients with clinical improvement|Hospital and ICU length of stay;|Duration of invasive mechanical ventilation|Duration of vasopressor use|Renal failure by AKIN criteria|Incidence of cardiovascular complications|Incidence of venous thromboembolism|Mortality
|
NCT04485429
|
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia |
Withdrawn |
Phase 3 |
Jul/20/2020 |
Dec/31/2022 |
- Alternative id - 31180820600005249
- Interventions - Drug: Methylprednisolone|Drug: Heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - D'Or Institute for Research and Education, Rio de Janeiro, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of invasive mechanical ventilation|Severity assessment by ordinal severity scale|Severity assessment by SOFA score|Length of hospital stay|Length of stay in intensive care|Death rate
|
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
|
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
|
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
|
NCT04743011
|
Enriched Heparin Anti COVID-19 Trial |
Recruiting |
Phase 1|Phase 2 |
Jun/01/2021 |
Dec/31/2021 |
- Alternative id - UPECLIN-MB-2
- Interventions - Drug: Heparin sodium|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital das Clinicas de Boucatu, Botucatu, Sao Paulo, Brazil|School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil, Botucatu, SP, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 50
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Change in activated partial thromboplastin time (APTT) > 1.5|Viral load in nasal swab reverse transcription polymerase chain reaction (RT-PCR).|Number of participants needing supplemental oxygen therapy|Number of participants needing mechanical pulmonary ventilation|Number of hospitalization days|Number of participants that develop renal failure|Number of participants that develop major cardiovascular events|Number of participants transferred to the intensive care unit (ICU)|Number of participants presenting secondary pulmonary bacterial infections|Number of participants that develop deep vein thrombosis (DVT)|Number of participants that develop pancreatitis|Number of participants that need corticosteroid therapy|Number of deaths among participants|Number of participants with increased white blood cell count|Number of participants with increased C reactive protein test|Number of participants with deterioration of arterial blood gas paO2/pFiO2 ratio|Number of participants with altered sodium|Number of participants with altered potassium|Number of participants with increased pulmonary area compromised (%)
|
NCT05279391
|
Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19 |
Recruiting |
Not Applicable |
Oct/25/2020 |
Dec/31/2023 |
- Alternative id - 87/08-04-2020|16210/20-04-2021
- Interventions - Drug: Dexamethasone|Drug: Low molecular weight heparin|Drug: Anakinra 100Mg/0.67Ml Inj Syringe|Drug: Tocilizumab|Drug: Baricitinib|Drug: Dornase Alfa Inhalant Product
- Study type - Interventional
- Study results - No Results Available
- Locations - University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
- Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - In-hospital mortality rate|Intubation rate|Days of hospitalization|Overall mortality rate
|
NCT04655586
|
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 |
Completed |
Phase 2|Phase 3 |
Dec/10/2020 |
Jan/19/2022 |
- Alternative id - NAPc-201/301
- Interventions - Drug: rNAPc2|Drug: Heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - ARCA Investigational Site #119, Fairhope, Alabama, United States|ARCA Investigational Site #118, Phoenix, Arizona, United States|ARCA Investigational Site #120, Tucson, Arizona, United States|ARCA Investigational Site #104, Aurora, Colorado, United States|ARCA Investigational Site #117, Denver, Colorado, United States|ARCA Investigational Site #101, Jacksonville, Florida, United States|ARCA Investigational Site #128, Evanston, Illinois, United States|ARCA Investigational Site #113, New Orleans, Louisiana, United States|ARCA Investigational Site #105, Falls Church, Virginia, United States|ARCA Investigational Site #114, Richmond, Virginia, United States|ARCA Investigational Site #103, Tacoma, Washington, United States|ARCA Investigational Site #127, San Nicolás, Buenos Aires, Argentina|ARCA Investigational Site #130, Rosario, Santa Fe, Argentina|ARCA Investigational Site #112, Rosario, Sante Fe, Argentina|ARCA Investigational Site #111, Buenos Aires, Argentina|ARCA Investigational Site #115, Caba, Argentina|ARCA Investigational Site #126, Cordoba, Argentina|ARCA Investigational Site #129, San Miguel de Tucuman, Argentina|ARCA Investigational Site #106, San Miguel De Tucumán, Argentina|ARCA Investigational Site #125, Campo Grande, Mato Grosso Do Sul, Brazil|ARCA Investigational Site #124, Braganca Paulista, Sao Paolo, Brazil|ARCA Investigational Site #122, Sao Jose do Rio Preto, Sao Paolo, Brazil|ARCA Investigational Site #123, Porto Alegre, Brazil|ARCA Investigational Site #121, São Paulo, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 160
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - Change in D-dimer level from Baseline to Day 8, or day of discharge if prior to Day 8 (Phase 2b)|Number of major or non-major clinically relevant bleeding events within eight (8) days of randomization as compared to heparin (Phase 2b and 3)|Time to recovery within thirty (30) days of randomization using the ACTT ordinal scale (Phase 3)|Change in D-dimer level from baseline to 24 hours post-dose (Day 2) and Day 3 (Phase 2b)|Number of major or non-major clinically relevant bleeding events with rNAPc2 vs. heparin through Day 30 (Phase 2b and 3)|Number of bleeding events in subjects treated with higher vs. lower dose rNAPc2 through Day 30 (Phase 2b)|Time to first occurrence of a composite of thrombotic events and all-cause mortality within thirty (30) days of randomization (Phase 3 only)|Time to first occurrence of thrombotic events within thirty (30) days of randomization (Phase 3 only)|Time to all-cause mortality within thirty (30) days of randomization (Phase 3 only)|Change in Tissue Factor laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline through Day 8 (Phase 2b)|Change in interleukin-6 laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline through Day 8 (Phase 2b)|Change in high sensitivity C-reactive protein laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline through Day 8 (Phase 2b)
|
NCT04668404
|
Study of Coagulation Profile and Role of Heparin Like Effect in Patients With COVID-19 |
Recruiting |
|
Aug/24/2020 |
Feb/01/2021 |
- Alternative id - IEC-04/2020-1641
- Interventions - Diagnostic Test: Sonoclot
- Study type - Observational
- Study results - No Results Available
- Locations - PGIMER, Chandigarh, India
- Study designs - Observational Model: Case-Only|Time Perspective: Prospective
- Enrollment - 50
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Correlation of of conventional coagulation tests with point of care coagulation test using sonoclot in COVID-19 patients.|Clinical Evidence of thrombosis|Coagulation-related Bleeding Event|Presence of Endogenous Heparinoids as demonstrated on POC test [ Time Frame 0, 3 days]|Intensive care admission duration|28 day mortality
|
NCT04344756
|
Trial Evaluating Efficacy and Safety of Anticoagulation in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort |
Not yet recruiting |
Phase 2 |
Apr/20/2020 |
Sep/30/2020 |
- Alternative id - APHP200389-6
- Interventions - Drug: Tinzaparin or unfractionated heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - Réanimation hôpital Louis Mourier, Colombes, Hauts De Seine, France|réanimation hôpital Cochin, Paris, France|Médecine vasculaire, Hôpital Européen Georges Pompidou, Paris, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 808
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Survival without ventilation (VNI or mechanical ventilation)|ventilator free survival|World Health Organisation(WHO) progression scale ≤5|World Health Organisation(WHO) progression scale|overall survival|Length of hospital stay|Length of ICU stay|time to oxygenation supply independency|time to ventilator (non invasive or invasive)|rate of acute kidney injury|time to Renal Replacement Therapy (RRT) initiation|rate of clinically overt pulmonary embolism or proximal deep vein thrombosis|Rate of clinically overt arterial thrombosis|Rate of unscheduled central venous catheter replacement for catheter dysfunction|Rate of central venous catheter-related deep vein thrombosis (CVC-DVT)|Rate of unscheduled indwelling arterial catheter replacement for catheter dysfunction|Rate of acute clotting leading to the replacement the renal replacement therapy circuit stratified by regional citrate anticoagulation or not|Time to acute clot formation within the oxygenator (acute oxygenator thrombosis, AOT) leading to the exchange of an extracorporeal membrane oxygenation (ECMO) system|Time to acute clot formation within the pump head (pump head thrombosis, PHT) leading to the exchange of an extracorporeal membrane oxygenation (ECMO) system|Incidence of adverse events
|
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
|
NCT04359212
|
Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19 |
Completed |
|
May/01/2020 |
Jul/31/2020 |
- Alternative id - VTE-COVID
- Interventions - Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux
- Study type - Observational
- Study results - No Results Available
- Locations - Giuseppe Camporese, Padova, Italy
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 90
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism|the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism
|
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
|
NCT04511923
|
Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury |
Recruiting |
Phase 1|Phase 2 |
Dec/23/2020 |
Jan/01/2022 |
- Alternative id - NUIG-2020-003
- Interventions - Drug: Nebulised heparin
- Study type - Interventional
- Study results - No Results Available
- Locations - University Hospital Galway, Galway, Ireland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - D-dimer profile|Frequenccy of Severe Adverse Outcomes|Oxygenation Index|Indices of Inflammation|Ratios of Indices of Inflammation|Indices of Coagulation|Quasi-Static Lung Compliance|Time to separation from advanced respiratory support|Number treated with neuromuscular blockers|Number treated with Prone positioning|Number treated with extra-corporeal membrane oxygenation|Number requiring Tracheostomy|Time to separation from invasive ventilation among survivors|Discharge to ward|Discharge to ward in survivors|Patient Survival|Number of patients residing at home or in a community setting at day 60|Number of surviving patients residing at home or in a community|Ventilatory ratio|Number treated with awake prone positioning
|
NCT04490239
|
Intranasal Heparin Tolerability Study |
Completed |
Early Phase 1 |
Oct/09/2020 |
Nov/18/2020 |
- Alternative id - Intranasal Heparin
- Interventions - Drug: Intranasal heparin sodium (porcine)
- Study type - Interventional
- Study results - Has Results
- Locations - The University of Mississippi National Center for Natural Products Research, University, Mississippi, United States
- Study designs - Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 6
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1|Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2|Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14|Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15|Percent Change in Platelet Count From Pre-dose Baseline|Number of Incidents of Epistaxis, Acute Phase|Number of Incidents of Epistaxis, Chronic Phase|Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14|Other Adverse Effects, Acute Phase|Other Adverse Effects, Chronic Phase
|
NCT04394182
|
Ultra Low Doses of Therapy With Radiation Applicated to COVID-19 |
Recruiting |
Not Applicable |
Apr/21/2020 |
Apr/21/2021 |
- Alternative id - 20.4.1597-GHM
- Interventions - Radiation: Ultra-Low-dose radiotherapy|Device: ventilatory support with oxygen therapy|Drug: Lopinavir/ritonavir|Drug: Hydroxychloroquine|Drug: Azithromycin|Drug: Piperacillin/tazobactam|Drug: Low molecular weight heparin|Drug: Corticosteroid injection|Drug: Tocilizumab
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital La Milagrosa, GenesisCare, Madrid, Spain|Hospital Vithas Valencia Consuelo, Valencia, Spain
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care
- Enrollment - 15
- Age - 18 Years to 120 Years (Adult, Older Adult)
- Outcome measures - Oxygen Therapy Status at Day 2|Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2|Blood Gas Analysis at Day 2|Blood Test at Day 2|Oxygen Therapy Status at Day 5|Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5|Blood Test at Day 5|Oxygen Therapy Status at Day 7|Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7|Blood Test at Day 7|Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7|Recovery time|COVID-19 status|Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1|Acute Toxicity
|
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
|
NCT04355728
|
Use of UC-MSCs for COVID-19 Patients |
Completed |
Phase 1|Phase 2 |
Apr/25/2020 |
Oct/31/2020 |
- Alternative id - 20200671|20200370
- Interventions - Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.|Other: Vehicle + Heparin along with best supportive care
- Study type - Interventional
- Study results - Has Results
- Locations - Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 24
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of Participants With Pre-Specified Infusion Associated Adverse Events|Number of Subjects With Serious Adverse Events by 31 Days After First Infusion|Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity|Subjects With Adverse Events and Serious Adverse Events by Severity|Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment|Subjects With Adverse Events by Relatedness to Treatment|Survival at 31 Days Post First Infusion|Survival at 60 Days Post First Infusion|Time to Recovery|Ventilator-Free Days Throughout 28 Days Post Second Infusion|Ventilator-Free Days Throughout 90 Days|Respiratory Rate and Oxygenation Index (ROX Index)|Oxygenation Index (OI)|Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)|Sequential Organ Failure Assessment (SOFA) Scores|Smell Identification Test (SIT) Scores|White Blood Cell Count (WBC)|Platelets Count|Hemogoblin|Hematocrit|Neutrophils|Lymphocytes|Glomerular Filtration Rate|Total Protein|Sodium|Potassium|Creatinine|Glucose|Albumin|Alkaline Phosphatase|Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)|Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)|Total Bilirubin|Blood Urea Nitrogen (BUN)|Calcium|Chloride|Carbon Dioxide (CO2)|C-Reactive Protein Levels|Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio|D-dimer Levels|25-Hydroxy Vitamin D Levels|Tumor Necrosis Factor-alpha (TNFα)|Tumor Necrosis Factor-beta (TNFβ)|Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)|Viral Load by SARS-CoV-2 RT-PCR|Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion|Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion|Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion|Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG
|