NCT04348071
|
Safety and Efficacy of Ruxolitinib for COVID-19 |
Withdrawn |
Phase 2|Phase 3 |
Jul/01/2021 |
Oct/01/2021 |
- Alternative id - 20-0869
- Interventions - Drug: Ruxolitinib
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years to 89 Years (Adult, Older Adult)
- Outcome measures - Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs)|Phase 2: Cumulative incidence of serious adverse events (SAEs)|Phase 2: Changes in white blood cell count (CBC) through Day 15|Phase 2: Changes in hemoglobin through Day 15|Phase 2: Changes in platelets through Day 15|Phase 2: Changes in creatinine through Day 15|Phase 2: Changes in glucose through Day 15|Phase 2: Changes in prothrombin time (PT) through Day 15|Phase 2: Changes in total bilirubin through Day 15|Phase 2: Changes in ALT through Day 15|Phase 2: Changes in AST through Day 15|Phase 2: Changes in white blood cell count (CBC) through End of Study (EOS)|Phase 2: Changes in hemoglobin through End of Study (EOS)|Phase 2: Changes in platelets through End of Study (EOS)|Phase 2: Changes in creatinine through End of Study (EOS)|Phase 2: Changes in glucose through End of Study (EOS)|Phase 2: Changes in prothrombin time (PT) though End of Study (EOS)|Phase 2: Changes in total bilirubin through End of Study (EOS)|Phase 2: Changes in ALT through End of Study (EOS)|Phase 2: Changes in AST through End of Study (EOS)|Phase 3: Percentage of patients reporting each severity on an 8-point ordinal scale at Day 15|Phase 2: Change in the 8-point ordinal scale|Phase 2: Change in National Early Warning Score (NEWS)|Phase 3: Change in the 8-point ordinal scale|Phase 3: Change in National Early Warning Score (NEWS)|Phase 3: Time to an improvement of one category using the 8-point ordinal scale|Phase 3: Time to an improvement of two categories using the 8-point ordinal scale|Phase 3: Time to discharge or to a NEWS ≤2 and maintained for 24 hours, whichever occurs first|Phase 3: Cumulative incidence of Grade 3 and 4 adverse events (AEs)|Phase 3: Cumulative incidence of serious adverse events (SAEs)|Phase 3: Duration of hospitalization|Phase 3: Duration of new oxygen use|Phase 3: Duration of new ventilator or ECMO use|Phase 3: Incidence of discontinuation or temporary suspension of drug for any reason|Phase 3: Incidence of new oxygen use|Phase 3: Incidence of new ventilator use|Phase 3: Number of oxygen free days|Phase 3: Number of ventilator or ECMO free days|Phase 3: 14 day mortality rate|Phase 3: 28 day mortality rate|Phase 3: Changes in white blood cell count (CBC) through Day 15|Phase 3: Changes in hemoglobin through Day 15|Phase 3: Changes in platelets through Day 15|Phase 3: Changes in creatinine through Day 15|Phase 3: Changes in glucose through Day 15|Phase 3: Changes in prothrombin time (PT) through Day 15|Phase 3: Changes in total bilirubin through Day 15|Phase 3: Changes in ALT through Day 15|Phase 3: Changes in AST through Day 15|Phase 3: Changes in white blood cell count (CBC) through End of Study (EOS)|Phase 3: Changes in hemoglobin through End of Study (EOS)|Phase 3: Changes in platelets through End of Study (EOS)|Phase 3: Changes in creatinine through End of Study (EOS)|Phase 3: Changes in glucose through End of Study (EOS)|Phase 3: Changes in prothrombin time (PT) though End of Study (EOS)|Phase 3: Changes in total bilirubin through End of Study (EOS)|Phase 3: Changes in ALT through End of Study (EOS)|Phase 3: Changes in AST through End of Study (EOS)
|
NCT04348695
|
Study of Ruxolitinib Plus Simvastatin in the Prevention and Treatment of Respiratory Failure of COVID-19. |
Recruiting |
Phase 2 |
Apr/12/2020 |
May/13/2020 |
- Alternative id - Ruxo-Sim-20|2020-001405-23
- Interventions - Drug: Ruxolitinib plus simvastatin|Other: Standard of Care
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Universitario Madrid Sanchinarro, Madrid, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 94
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of patients who develop severe respiratory failure.|Length of ICU stay.|Length of hospital stay|Survival rate at 6 months|Survival rate at 12 months|Survival rate at 28 days|Percentage of patients with each AE by grade|Percentage of patients who discontinued due to AEs
|
NCT04355793
|
Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection |
No longer available |
|
Jan/01/1970 |
Jan/01/1970 |
- Alternative id - INCB 18424-MA-COVID-19-301
- Interventions - Drug: Ruxolitinib
- Study type - Expanded Access:Treatment IND/Protocol
- Study results - No Results Available
- Locations -
- Study designs -
- Enrollment -
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures -
|
NCT04337359
|
Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness |
No longer available |
|
Jan/01/1970 |
Jan/01/1970 |
- Alternative id - CINC424A2001M
- Interventions - Drug: Ruxolitinib
- Study type - Expanded Access:Intermediate-size Population
- Study results - No Results Available
- Locations -
- Study designs -
- Enrollment -
- Age - 6 Years to 90 Years (Child, Adult, Older Adult)
- Outcome measures -
|
NCT04359290
|
Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS |
Completed |
Phase 2 |
Jul/01/2020 |
Jul/30/2021 |
- Alternative id - KKS-278
- Interventions - Drug: Ruxolitinib administration
- Study type - Interventional
- Study results - No Results Available
- Locations - Andreas Neubauer, Marburg, Germany
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 15
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Overall survival|Assessment of the duration of ventilation support|cytokine storm|time on ICU|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)|Rates of flow|Gas exchange|Forced expiratory volume in 1 second (FEV1)|Forced vital capacity (FVC)|Tiffeneau-Pinelli index
|
NCT04354714
|
Ruxolitinib to Combat COVID-19 |
Withdrawn |
Phase 2 |
Jun/30/2020 |
Dec/31/2021 |
- Alternative id - 04-13-20-DiPersio
- Interventions - Drug: Ruxolitinib|Procedure: Peripheral blood draw
- Study type - Interventional
- Study results - No Results Available
- Locations -
- 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 - Overall survival|Length of hospital stay|Length of ICU stay|Duration of ventilator use|Duration of vasopressors use|Duration on renal replacement therapy|Viral kinetics as measured by virologic failure|Number of adverse events as measured by CTCAE v. 5.0|Proportion of participants with detectable virus
|
NCT04374149
|
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS |
Completed |
Phase 2 |
Apr/30/2020 |
Dec/01/2020 |
- Alternative id - PHU COVID-19-001
- Interventions - Procedure: Therapeutic Plasma Exchange|Drug: Ruxolitinib
- Study type - Interventional
- Study results - Has Results
- Locations - Prisma Health, Greenville, South Carolina, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 20
- Age - 12 Years to 80 Years (Child, Adult, Older Adult)
- Outcome measures - C-reactive Protein (CRP) Levels at Baseline and Day 14|Cytokine Levels at Baseline and Day 14
|
NCT04334044
|
Treatment of SARS Caused by COVID-19 With Ruxolitinib |
Completed |
Phase 1|Phase 2 |
Sep/01/2020 |
Apr/30/2021 |
- Alternative id - HAL 345/2020
- Interventions - Drug: Ruxolitinib Oral Tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Grupo Cooperativo de Hemopatías Malignas, Huixquilucan, Estado De México, Mexico
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 77
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Recovery of Pneumonia|Response of C-reactive protein|Response of Ferritin|Response of D-dimer|Rate of ICU admission|Rate of mechanical ventilation|Overall Survival|Toxicity Rate
|
NCT04338958
|
Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation |
Completed |
Phase 2 |
Apr/22/2020 |
Jul/15/2021 |
- Alternative id - RuxCoFlam
- Interventions - Drug: Ruxolitinib
- Study type - Interventional
- Study results - No Results Available
- Locations - SRH Wald-Klinikum Gera GmbH, Gera, Germany|University Hospital Jena, Jena, Germany|UKSH, Campus Lübeck, Lübeck, Germany|Klinikum der Landeshauptstadt Stuttgart gKöR, Stuttgart, Germany|Universitätsklinikum Ulm, Ulm, Germany|Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen, Germany
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 193
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - overall response rate in reversal of hyperinflammation
|
NCT04377620
|
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT) |
Terminated |
Phase 3 |
May/24/2020 |
Feb/26/2021 |
- Alternative id - INCB 18424-369
- Interventions - Drug: Placebo|Drug: Ruxolitinib
- Study type - Interventional
- Study results - Has Results
- Locations - Honor Health Research Institute, Scottsdale, Arizona, United States|Sharp Memorial Hospital, San Diego, California, United States|Georgetown University Hospital, Washington, District of Columbia, United States|Teradan Clinical Trials, Brandon, Florida, United States|University of Florida, Gainesville, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|University of South Florida, Tampa, Florida, United States|Northshore University Health System, Chicago, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|Indiana University Simon Cancer Center, Indianapolis, Indiana, United States|Indiana University Health Central Indiana Cancer Centers, Indianapolis, Indiana, United States|East Jefferson General Hospital, Metairie, Louisiana, United States|Johns Hopkins University, Baltimore, Maryland, United States|Boston Medical Center, Boston, Massachusetts, United States|Lahey Hospital & Medical Center, Burlington, Massachusetts, United States|University of Massachusetts Medical School, Worcester, Massachusetts, United States|Healthpartners Cancer Care Center - Regions Hospital, Saint Paul, Minnesota, United States|Mercy Research, Springfield, Missouri, United States|Hackensack University Medical Center, Hackensack, New Jersey, United States|Rutgers Njms Clinical Research Unit, Newark, New Jersey, United States|Holy Name Medical Center, Teaneck, New Jersey, United States|University of Rochester Medical Center, Rochester, New York, United States|Duke University Medical Center, Durham, North Carolina, United States|East Carolina University, Greenville, North Carolina, United States|University of Cincinnati, Cincinnati, Ohio, United States|Kettering Cancer Care, Dayton, Ohio, United States|Jefferson University Hospitals, Philadelphia, Pennsylvania, United States|Temple University, Philadelphia, Pennsylvania, United States|West Penn Hospital, Pittsburgh, Pennsylvania, United States|Allegheny Health Network, Wexford, Pennsylvania, United States|St David'S Medical Center, Austin, Texas, United States|University of Texas Health Science Center At Houston - McGovern Medical School, Houston, Texas, United States|University of Texas Health Science Cente, San Antonio, Texas, United States|Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States|Aurora Research Institute, Milwaukee, Wisconsin, United States|Sbih City Hospital 15, Saint Petersburg, Russian Federation
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 211
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Percentage of Participants Who Have Died Due to Any Cause|Number of Ventilator Free Days|Number of ICU Free Days|Oxygen Free Days|Vasopressor Free Days|Hospital Free Days|Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale|Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale|Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale|Percentage of Participants With the COVID-19 Ordinal Scale Reported|Change in the COVID-19 9-point Ordinal Scale|Change in SOFA Score|Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events
|
NCT04424056
|
A Trial Using ANAKINRA, TOCILIZUMAB Alone or in Association With RUXOLITINIB in Severe Stage 2b and 3 of COVID19-associated Disease |
Not yet recruiting |
Phase 3 |
Sep/01/2020 |
Nov/01/2022 |
- Alternative id - 2020-23
- Interventions - Drug: Anakinra +/- Ruxolitinib (stages 2b/3)|Drug: Anakinra and Ruxolitinib (Advanced stage 3)|Drug: Tocilizumab +/- ruxolitinib (stages 2b/3)|Drug: Tocilizumab and Ruxolitinib (Advanced stage 3)|Other: Standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - Assistance Publique Hôpitaux de Marseille, Marseille, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 216
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Ventilation free days at D28
|
NCT04362137
|
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm |
Completed |
Phase 3 |
May/02/2020 |
Oct/17/2020 |
- Alternative id - CINC424J12301|INCB 18424-368|2020-001662-11
- Interventions - Drug: Ruxolitinib|Drug: Placebo
- Study type - Interventional
- Study results - Has Results
- Locations - Novartis Investigative Site, Fullerton, California, United States|Novartis Investigative Site, Aurora, Colorado, United States|Novartis Investigative Site, Denver, Colorado, United States|Novartis Investigative Site, Atlanta, Georgia, United States|Novartis Investigative Site, Idaho Falls, Idaho, United States|Novartis Investigative Site, Ann Arbor, Michigan, United States|Novartis Investigative Site, Newark, New Jersey, United States|Novartis Investigative Site, Bronx, New York, United States|Novartis Investigative Site, Mesquite, Texas, United States|Novartis Investigative Site, Seattle, Washington, United States|Novartis Investigative Site, Madison, Wisconsin, United States|Novartis Investigative Site, C A B A, Buenos Aires, Argentina|Novartis Investigative Site, Buenos Aires, Argentina|Novartis Investigative Site, Buenos Aires, Argentina|Novartis Investigative Site, Rio de Janeiro, RJ, Brazil|Novartis Investigative Site, Blumenau, Santa Catarina, Brazil|Novartis Investigative Site, Barretos, SP, Brazil|Novartis Investigative Site, Sao Paulo, SP, Brazil|Novartis Investigative Site, Sao Paulo, SP, Brazil|Novartis Investigative Site, Sorocaba, SP, Brazil|Novartis Investigative Site, Rionegro, Antioquia, Colombia|Novartis Investigative Site, Barranquilla, Atlantico, Colombia|Novartis Investigative Site, Barranquilla, Colombia|Novartis Investigative Site, Colombes Cedex, France|Novartis Investigative Site, Eaubonne, France|Novartis Investigative Site, Nantes Cedex 1, France|Novartis Investigative Site, Pessac, France|Novartis Investigative Site, Pierre Benite, France|Novartis Investigative Site, Lubeck, Germany|Novartis Investigative Site, Muenchen, Germany|Novartis Investigative Site, Nuernberg, Germany|Novartis Investigative Site, México, Distrito Federal, Mexico|Novartis Investigative Site, Ciudad de Mexico, Mexico CP, Mexico|Novartis Investigative Site, Estado de Mexico, Mexico|Novartis Investigative Site, San Isidro, Lima, Peru|Novartis Investigative Site, San Miguel, Lima, Peru|Novartis Investigative Site, Lima, Peru|Novartis Investigative Site, Lima, Peru|Novartis Investigative Site, Barnaul, Russian Federation|Novartis Investigative Site, Moscow, Russian Federation|Novartis Investigative Site, Moscow, Russian Federation|Novartis Investigative Site, Ryazan, Russian Federation|Novartis Investigative Site, S-Petersburg, Russian Federation|Novartis Investigative Site, Saint Petersburg, Russian Federation|Novartis Investigative Site, Saint Petersburg, Russian Federation|Novartis Investigative Site, Sestroretsk, Russian Federation|Novartis Investigative Site, St Petersburg, Russian Federation|Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain|Novartis Investigative Site, Barcelona, Cataluna, Spain|Novartis Investigative Site, Badalona, Catalunya, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Istanbul, TUR, Turkey|Novartis Investigative Site, Ankara, Turkey|Novartis Investigative Site, Istanbul, Turkey|Novartis Investigative Site, Yenisehir/Izmir, Turkey|Novartis Investigative Site, Harrow, United Kingdom|Novartis Investigative Site, Leeds, United Kingdom|Novartis Investigative Site, London, United Kingdom|Novartis Investigative Site, London, United Kingdom|Novartis Investigative Site, Manchester, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 432
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care|Clinical Status|Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status|Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status|Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status|Time to Improvement in Clinical Status|Mean Change From Baseline in the Clinical Status|Mortality Rate|Proportion of Patients Requiring Mechanical Ventilation|Duration of Hospitalization|Time to Hospital Discharge or to a NEWS2 Score of ≤2|Change From Baseline in NEWS2 Score|Change From Baseline in SpO2/FiO2 Ratio|Proportion of Patients With no Oxygen Therapy
|
NCT04361903
|
Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection |
Not yet recruiting |
|
Apr/25/2020 |
May/31/2020 |
- Alternative id - 2020.COVID-19.RUXO106
- Interventions - Drug: Ruxolitinib Oral Tablet
- Study type - Observational
- Study results - No Results Available
- Locations -
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 13
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19|Improvement of respiratory performance - Arterial Blood Gas Analisys - pH|Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2|Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2|Improvement of respiratory performance - ratio values|Evaluation of known adverse events related to the use of the drug - D-Dimer|Evaluation of known adverse events related to the use of the drug - fibrinogen|Evaluation of known adverse events related to the use of the drug - transaminases|Evaluation of known adverse events related to the use of the drug - aPTT|Evaluation of known adverse events related to the use of the drug - INR|Evaluation of known adverse events related to the use of the drug - glycemia|Evaluation of known adverse events related to the use of the drug - creatinine|Evaluation of known adverse events related to the use of the drug - Leucocytes count|Evaluation of known adverse events related to the use of the drug - Leucocytes formula|Evaluation of the epidemiological parameters: Chest CT|Evaluation of the epidemiological parameters: Eco Chest|Evaluation of the epidemiological parameters: CHEST X-ray|Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment|Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy
|
NCT04414098
|
Ruxolitinib in the Treatment of Covid-19 |
Not yet recruiting |
Phase 2 |
Jun/01/2020 |
Sep/15/2020 |
- Alternative id - CZabala
- Interventions - Drug: INC424 / Ruxolitinib
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome|Evaluate the median duration of hospitalization.|Evaluate the evolution of systemic inflammation parameters.|Evaluate COVID-19 mortality rate|Evaluate the proportion of the requirement of mechanical ventilation.|Evaluate ruxolitinib adverse reactions|Evaluate the proportion of secondary infections during the treatment with ruxolitinib
|
NCT04477993
|
Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19 |
Terminated |
Phase 2|Phase 3 |
Aug/14/2020 |
Mar/29/2021 |
- Alternative id - 32894720.3.0000.0068
- Interventions - Drug: Janus Kinase Inhibitor (ruxolitinib)|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital das Clínicas, Sao Paulo, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 5
- Age - 18 Years to 95 Years (Adult, Older Adult)
- Outcome measures - A composite outcome of death or ICU admission or mechanical ventilation at day 14.|A composite outcome of death or ICU admission or mechanical ventilation at day 28|Time to treatment failure|Overall survival at days 14 and 28|Cumulative incidence of ICU admission rate at days 14 and 28|Cumulative incidence of mechanical ventilation at days 14 and 28|Duration of hospital stay|Duration of ICU stay|Duration of mechanical ventilation|Duration of non-invasive ventilation|Secondary hemophagocytic syndrome rate|Cumulative incidence nosocomial infection rate at days 14 and 28|Incidence of discontinuation of oxygen supplementation at days 14 and 28|Rate of grade 1-2 and 3-5 emerging adverse events at day 28|Cumulative dose of methylprednisolone at days 14 and 28|Change in PaO2/FiO2 ratio from baseline to days 14 and 28|Change in interleukin 6 levels [pg/mL] from baseline to days 14 and 28|Change in d-dimer levels [ng/mL] from baseline to days 14 and 28|Change in fibrinogen levels [mg/dL] from baseline to days 14 and 28|Change in ferritin levels [ng/mL] from baseline to days 14 and 28|Change in C reactive protein levels [mg/L] from baseline to days 14 and 28|Change in alanine aminotransferase [U/L] from baseline to days 14 and 28|Change in aspartate aminotransferase [U/L] from baseline to days 14 and 28|Change in creatinine levels [mg/dL] from baseline to days 14 and 28|Change in glucose levels [mg/dL] from baseline to days 14 and 28|Change in hemoglobin levels [g/dL] from baseline to days 14 and 28|Change in platelet count [x10ˆ3/mmˆ3] from baseline to days 14 and 28|Change in absolute neutrophil count [x10ˆ3/mmˆ3] from baseline to days 14 and 28|Change in absolute neutrophil count [/mmˆ3] from baseline to days 14 and 28|Change in absolute lymphocyte count [/mmˆ3] from baseline to days 14 and 28|Change in prothrombin time ratio from baseline to days 14 and 28|Change in partial thromboplastin time ratio from baseline to days 14 and 28|Change in bilirubin [mg/dl] from baseline to days 14 and 28|Change in lactate dehydrogenase [U/L] from baseline to days 14 and 28|Change in CPK-MB [ng/mL] from baseline to days 14 and 28|Change in troponin [ng/mL] from baseline to days 14 and 28|Change in von Willebrand factor antigen level (VWF:Ag) [%] from baseline to days 14 and 28|Change in von Willebrand factor activity (ristocetin cofactor) [%] from baseline to days 14 and 28|Change in ADAMTS-13 [%] from baseline to days 14 and 28|Change in von Willebrand multimeters from baseline to days 14 and 28|Change in plasminogen activator inhibitor-1 levels [ng/mL] from baseline to days 14 and 28|Change in E-selectin levels [ng/mL] from baseline to days 14 and 28|Change in P-selectin levels [ng/mL] from baseline to days 14 and 28|Change in endothelin [fmol/mL] from baseline to days 14 and 28|Change in circulating microparticles from baseline to days 14 and 28|Change in thromboelastography from baseline to days 14 and 28
|
NCT04581954
|
Inflammatory Signal Inhibitors for COVID-19 (MATIS) |
Recruiting |
Phase 1|Phase 2 |
Oct/02/2020 |
Dec/01/2021 |
- Alternative id - 20HH5926|2020-001750-22
- Interventions - Drug: Ruxolitinib|Drug: Fostamatinib|Other: Standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - Imperial College Healthcare NHS Trust, London, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 456
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - All-cause mortality|Number and proportion of patients requiring invasive ventilation|Number and proportion of patients requiring non-invasive ventilation (CPAP and high flow nasal oxygen)|Number and proportion of patients requiring invasive ventilation or extracorporeal membrane oxygenation (ECMO)|Number and proportion of patients requiring non-invasive ventilation including continuous positive airway pressure (CPAP) or high flow nasal oxygen|Number and proportion of patients requiring renal replacement therapy|Number and proportion of patients experiencing venous thromboembolism events|Length of stay|Number and proportion of serious adverse events and discontinuations|Absolute change in pneumonia severity on the modified WHO COVID-19 Ordinal Scale
|
NCT04366232
|
Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation |
Terminated |
Phase 2 |
Aug/19/2020 |
Oct/02/2020 |
- Alternative id - 2020-CHITS-003|2020-001963-10
- Interventions - Drug: Anakinra alone (stages 2b/3)|Drug: Anakinra and Ruxolitinib (overcome stage 3)|Other: Standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - AP-HM, Hôpital de la Conception, Marseille, Bouches-du-Rhône, France|Hôpital Sainte-Musse, Toulon, VAR, France|Sainte Anne Teaching Military Hospital, Toulon, Var, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Biological criteria|Duration of oxygen therapy (days)|Number of intensive care units admissions|Number of days in intensive care units|Mortality rate|Total number of days in hospital|Organ failure score modification (Sepsis-related Organ Failure Assessment (SOFA) score)|Number of bacterial and/or fungal sepsis
|
NCT04331665
|
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia |
Terminated |
Not Applicable |
May/21/2020 |
Mar/24/2021 |
- Alternative id - U-DEPLOY: RUX-COVID|20-5315
- Interventions - Drug: Ruxolitinib
- Study type - Interventional
- Study results - No Results Available
- Locations - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 3
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)|Number of adverse events|All cause mortality rate|Average duration of hospital stay
|
NCT04403243
|
COLchicine Versus Ruxolitinib and Secukinumab In Open Prospective Randomized Trial |
Recruiting |
Phase 2 |
May/08/2020 |
Aug/23/2020 |
- Alternative id - MSU080520
- Interventions - Drug: Colchicine|Drug: Ruxolitinib 5 MG|Drug: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]|Other: standard therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - Lomonosov Moscow State University Medical Research and Educational Center, Moscow, Moscow Region, Russian Federation
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 70
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline|Combine endpoint: Time to death or mechanical ventilation|C-reactive protein|D-dimer|EuroQol Group. EQ-5D™|exposure area on lung CT
|