Covid 19 Research using Clinical Trials (Home Page)
HP:0001928: Abnormality of coagulationHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (18)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug253 | Cellectra 2000 Electroporation Wiki | 0.50 |
| drug802 | Other drugs Wiki | 0.50 |
| drug1148 | Therapeutic Anticoagulation Wiki | 0.50 |
| drug964 | Reverse-transcription polymerase chain reaction (RT-PCR) Wiki | 0.50 |
| drug259 | Chest computed tomography (CT) Wiki | 0.50 |
| drug1160 | Thrombin generation test assay Wiki | 0.50 |
| drug1066 | Standard of Care thromboprophylaxis Wiki | 0.50 |
| drug594 | Intermediate dose thromboprophylaxis Wiki | 0.50 |
| drug436 | Fibrin generation markers assays Wiki | 0.50 |
| drug1159 | Thrombin Generation Assay (TGA) Wiki | 0.50 |
| drug245 | Caption AI Wiki | 0.50 |
| drug1161 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.50 |
| drug749 | Niclosamide Wiki | 0.35 |
| drug450 | GLS-5300 Wiki | 0.35 |
| drug752 | Nitazoxanide Wiki | 0.29 |
| drug612 | Ivermectin Wiki | 0.20 |
| drug262 | Chloroquine Wiki | 0.19 |
| drug431 | Favipiravir Wiki | 0.16 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020141 | Hemostatic Disorders NIH | 1.00 |
| D001778 | Blood Coagulation Disorders NIH | 1.00 |
| D004211 | Disseminated Intravascular Coagulation NIH | 0.58 |
| D016638 | Critical Illness NIH | 0.11 |
| D014777 | Virus Diseases NIH | 0.07 |
| D007239 | Infection NIH | 0.04 |
Correlated HPO Terms (1)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005521 | Disseminated intravascular coagulation HPO | 0.58 |
There are 4 clinical trials
Clinical Trials
1 Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)
Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
NCT04356144 Disseminated Intravascular Coagulation Critical Illness Sars-CoV2 Viral Infection Coagulation Disorder, Blood Covid19 Diagnostic Test: Thrombin Generation Assay (TGA) Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) MeSH:Infection Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation Critical Illness Virus Diseases
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation
Primary Outcomes
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 months
Description: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 months
Description: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 months
Description: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 months
2 Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients
Primary Outcomes
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 monthsDescription: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 monthsDescription: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 monthsDescription: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 monthsIncreased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.
NCT04356950 Sepsis Blood Coagulation Disorders Thrombin Disseminated Intravascular Coagulation COVID-19 Other: Thrombin generation test assay Other: Fibrin generation markers assays MeSH:Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation
Primary Outcomes
Description: Death yes/no during hopstilization, 28 days after admittence
Measure: 28-day survival rate Time: 1 month
Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test latent period Time: Day 0
Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test latent period compared to reference plasma Time: Day 0
Description: nmol/s; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test initial velocity Time: Day 0
Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test initial velocity compared to reference plasma Time: Day 0
Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test peak thrombin compared to reference plasma Time: Day 0
Description: nmol/L; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test peak thrombin Time: Day 0
Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test peak thrombin time Time: Day 0
Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test peak thrombin time compared to reference plasma Time: Day 0
Description: seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test total thrombin generation time Time: Day 0
Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test total thrombin generation time compared to reference plasma Time: Day 0
Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test endogenous thrombin potential Time: Day 0
Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test endogenous thrombin potential compared to reference plasma Time: Day 0
Secondary Outcomes
Description: Death yes/no
Measure: 3-month survival rate Time: 3 months
Description: Yes/no
Measure: Transfer to intensive care unit during hospitalization Time: 3 months
Description: Yes/no (deep vein thrombosis, pulmonary embolism, atherothrombosis flare, arterial thrombosis)
Measure: Thrombotic complication during hospitalization Time: 3 months
Description: µg / L, assayed by automated enzyme linked fluorescent assay (Vidas® D-dimers Exclusion ™ II)
Measure: Plasma concentrations of D-dimers Time: Day 0
Description: mg / L, measured by automated immunoagglutination (STA®-Liatest® FM)
Measure: Plasma concentrations of soluble fibrin monomers Time: Day 0
3 COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19
Primary Outcomes
Description: Death yes/no during hopstilization, 28 days after admittence
Measure: 28-day survival rate Time: 1 monthDescription: Seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test latent period Time: Day 0Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test latent period compared to reference plasma Time: Day 0Description: nmol/s; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test initial velocity Time: Day 0Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test initial velocity compared to reference plasma Time: Day 0Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test peak thrombin compared to reference plasma Time: Day 0Description: nmol/L; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test peak thrombin Time: Day 0Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test peak thrombin time Time: Day 0Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test peak thrombin time compared to reference plasma Time: Day 0Description: seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test total thrombin generation time Time: Day 0Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test total thrombin generation time compared to reference plasma Time: Day 0Description: Seconds; without (TM-) and with (TM+) purified thrombomodulin
Measure: Absolute thrombin generation test endogenous thrombin potential Time: Day 0Description: %; without (TM-) and with (TM+) purified thrombomodulin
Measure: Relative thrombin generation test endogenous thrombin potential compared to reference plasma Time: Day 0Secondary Outcomes
Description: Death yes/no
Measure: 3-month survival rate Time: 3 monthsDescription: Yes/no
Measure: Transfer to intensive care unit during hospitalization Time: 3 monthsDescription: Yes/no (deep vein thrombosis, pulmonary embolism, atherothrombosis flare, arterial thrombosis)
Measure: Thrombotic complication during hospitalization Time: 3 monthsDescription: µg / L, assayed by automated enzyme linked fluorescent assay (Vidas® D-dimers Exclusion ™ II)
Measure: Plasma concentrations of D-dimers Time: Day 0Description: mg / L, measured by automated immunoagglutination (STA®-Liatest® FM)
Measure: Plasma concentrations of soluble fibrin monomers Time: Day 0This prospective, randomized, open-label, single-center interventional study is designed to compare the safety and efficacy of two LMWH dosing protocols in patients admitted to the University of Iowa Hospitals with COVID-19 who meet the modified ISTH Overt DIC criteria score ≥3. Patients will be randomized to standard prophylactic dose LMWH (standard of care arm) or intermediate-dose LMWH (intervention arm).
NCT04360824 COVID 19 Associated Coagulopathy Drug: Intermediate dose thromboprophylaxis Drug: Standard of Care thromboprophylaxis MeSH:Hemostatic Disorders Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade
Primary Outcomes
Description: Risk of all-cause mortality
Measure: Mortality Time: 30 Days post intervention
Secondary Outcomes
Description: Risk of ISTH defined major bleeding
Measure: Major Bleeding Time: 30 Days post intervention
Description: Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Measure: Arterial Thrombosis Time: 30 Days post intervention
Description: Risk of symptomatic venous thromboembolism
Measure: Venous Thromboembolism Time: 30 Days post intervention
Description: duration of intensive care measures
Measure: ICU admission, intubation/ventilation Time: 30 Days post intervention
Description: The number of units of packed red blood cells transfused
Measure: Packed Red Blood Cell Transfusions Time: 30 Days post intervention
Description: The number of units of platelets transfused
Measure: Platelet Transfusions Time: 30 Days post intervention
Description: The number of units of Fresh Frozen Plasma Transfused
Measure: Fresh Frozen Plasma Transfusions Time: 30 Days post intervention
Description: The number of units of Cryoprecipitate Transfused
Measure: Cryoprecipitate Transfusions Time: 30 Days post intervention
Description: The number of units of Prothrombin Complex ConcentrateTransfused
Measure: Prothrombin Complex Concentrate Transfusions Time: 30 Days post intervention
Other Outcomes
Description: Will be performed in stored plasma using Calibrated Automated Thrombogram. The endogenous thrombin potential will be calculated in units of nM.Min.
Measure: The endogenous thrombin potential will be determined within 24 hours of randomization and weekly for 30 days or until hospital discharge Time: 30 days post intervention
Description: These assays will be performed in stored plasma. Quantification of cfDNA will be performed using Qubit dsDNA HS Assay kit. Histones H4, citrullinated-histone and DNA-myeloperoxidase will be measured using commercially available ELISA kit.
Measure: Plasma levels of cell-free DNA will be determined within 24 hours of randomization and weekly for 30 days or until hospital discharge Time: 30 days post intervention
Description: will be measured in stored plasma using a commercially available ELISA kit.
Measure: PAI-1 Time: 30 days post intervention
4 Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG)
Primary Outcomes
Description: Risk of all-cause mortality
Measure: Mortality Time: 30 Days post interventionSecondary Outcomes
Description: Risk of ISTH defined major bleeding
Measure: Major Bleeding Time: 30 Days post interventionDescription: Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Measure: Arterial Thrombosis Time: 30 Days post interventionDescription: Risk of symptomatic venous thromboembolism
Measure: Venous Thromboembolism Time: 30 Days post interventionDescription: duration of intensive care measures
Measure: ICU admission, intubation/ventilation Time: 30 Days post interventionDescription: The number of units of packed red blood cells transfused
Measure: Packed Red Blood Cell Transfusions Time: 30 Days post interventionDescription: The number of units of platelets transfused
Measure: Platelet Transfusions Time: 30 Days post interventionDescription: The number of units of Fresh Frozen Plasma Transfused
Measure: Fresh Frozen Plasma Transfusions Time: 30 Days post interventionDescription: The number of units of Cryoprecipitate Transfused
Measure: Cryoprecipitate Transfusions Time: 30 Days post interventionDescription: The number of units of Prothrombin Complex ConcentrateTransfused
Measure: Prothrombin Complex Concentrate Transfusions Time: 30 Days post interventionOther Outcomes
Description: Will be performed in stored plasma using Calibrated Automated Thrombogram. The endogenous thrombin potential will be calculated in units of nM.Min.
Measure: The endogenous thrombin potential will be determined within 24 hours of randomization and weekly for 30 days or until hospital discharge Time: 30 days post interventionDescription: These assays will be performed in stored plasma. Quantification of cfDNA will be performed using Qubit dsDNA HS Assay kit. Histones H4, citrullinated-histone and DNA-myeloperoxidase will be measured using commercially available ELISA kit.
Measure: Plasma levels of cell-free DNA will be determined within 24 hours of randomization and weekly for 30 days or until hospital discharge Time: 30 days post interventionDescription: will be measured in stored plasma using a commercially available ELISA kit.
Measure: PAI-1 Time: 30 days post interventionCoagulopathy of COVID-19 afflicts approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by elevated D-dimer, an indicator of fibrin formation and clot lysis, and a mildly prolonged prothrombin time, suggestive of coagulation consumption. To date, it seems that COVID-19 coagulopathy manifests with thromboembolism, thus anticoagulation may be of benefit. We propose to conduct a parallel pragmatic multi-centre open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and an elevated D-dimer (≥2X upper limit of normal {ULN}).
NCT04362085 COVID-19 Drug: Therapeutic Anticoagulation MeSH:Hemostatic Disorders Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade
Primary Outcomes
Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Measure: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days. Time: Up to 28 days
Secondary Outcomes
Description: All-cause death
Measure: All-cause death Time: Up to 28 days
Description: Composite outcome of ICU admission or all-cause death
Measure: Composite outcome of ICU admission or all-cause death Time: Up to 28 days
Description: Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation
Measure: Major bleeding Time: Up to 28 days
Description: Red Blood Cell transfusion (greater than or equal to 1 unit)
Measure: Number of participants who received red blood cell transfusion Time: Up to 28 days
Description: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate
Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate. Time: Up to 28 days
Description: Hospital-free days alive up to day 28
Measure: Number of hospital-free days alive up to day 28 Time: Up to 28 days
Description: ICU-free days alive up to day 28
Measure: Number of ICU-free days alive up to day 28 Time: Up to 28 days
Description: Ventilator-free days alive up to day 28
Measure: Number of ventilator-free days alive up to day 28 Time: Up to 28 days
Description: Venous thromboembolism
Measure: Number of participants with venous thromboembolism Time: Up to 28 days
Description: Arterial thromboembolism
Measure: Number of participants with arterial thromboembolism Time: Up to 28 days
Description: Heparin induced thrombocytopenia
Measure: Number of participants with heparin induced thrombocytopenia Time: Up to 28 days
Description: D-dimer
Measure: Changes in D-dimer up to day 3 Time: Up to day 3
HPO Nodes
HP:0001928: Abnormality of coagulation
Genes 215
SRD5A3 KLKB1 PEX13 PRF1 GGCX PMM2 NR1H4 FGA IDH1 TCF4 PEX6 HAVCR2 NPM1 SLC30A10 AHCY PEX26 HSD3B7 VPS33A EFL1 DPM1 PRKAR1A OSTM1 TINF2 MCFD2 PEX12 FIP1L1 PROS1 ALG6 ZMPSTE24 MCFD2 SPTB MST1 PML SERPINC1 THBD TBL1XR1 F10 CFI F5 AKR1D1 GGCX SPTA1 TRMU IDH2 DOLK GNA14 PEX2 FAH RASA2 ACAD9 GATA6 ATP6V0A2 PEX11B TERT PEX14 RYR1 HBB DPM2 RFT1 LZTR1 TFAM ANK1 SOS1 ITGB3 TEK GP9 NHP2 RRAS F7 RIT1 LYST GNE HMGCL GP9 F8 HELLPAR PTH1R CACNA1S B4GALT1 COG8 LMNA RAF1 CD46 SRD5A3 ITGA2B PLG PARN ALDOB STX11 RFT1 F13B USB1 PROC F13A1 HSD3B7 LARS1 SERPINF2 STAT3 SSR4 VKORC1 PEX19 NGLY1 NBEAL2 SERPINC1 F2 SLC25A15 SSR4 SLC4A1 VWF F10 MGAT2 F9 RTEL1 SOS2 RRAS2 GGCX RTEL1 HAVCR2 RBM8A IRF2BP2 COG4 ATP6V1A PIGA NRAS LMAN1 F7 XIAP FGB ACD BCOR GP1BB F5 DLD PROS1 EPB42 AMACR PTPN11 HMGCL PEX5 BCS1L MAP2K1 AGA PARN F12 MYD88 DDOST NPM1 BRAF SLC7A7 PLAT GATA2 MPI CBL ALG12 ZBTB16 NUMA1 TINF2 DKC1 NBAS GPR35 AGGF1 PEX3 F8 PEX10 VWF STAT5B LMAN1 F11 PGM1 PMM2 FLNA RYR1 STIM1 F9 MPDU1 CYP7B1 PROC HADH GP1BB PEX16 CYP7B1 F11 ABCC2 SERAC1 ATP6V0A2 F13A1 CTC1 WRAP53 ORAI1 NOP10 GFI1B NABP1 UNC13D SLC25A13 HRG TERC DKC1 GP1BA KRAS MRAS PTPN11 PEX1 CFH F2 RARA ANO6 FGG GP1BA GPC1 F13B ALG2 ATP6V1E1 DPAGT1 A2ML1 TERT Protein Mutations 0
SNP 0
Primary Outcomes
Description: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days.
Measure: Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days. Time: Up to 28 daysSecondary Outcomes
Description: All-cause death
Measure: All-cause death Time: Up to 28 daysDescription: Composite outcome of ICU admission or all-cause death
Measure: Composite outcome of ICU admission or all-cause death Time: Up to 28 daysDescription: Major bleeding as defined by the ISTH Scientific and Standardization Committee (ISTH-SSC) recommendation
Measure: Major bleeding Time: Up to 28 daysDescription: Red Blood Cell transfusion (greater than or equal to 1 unit)
Measure: Number of participants who received red blood cell transfusion Time: Up to 28 daysDescription: Transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate
Measure: Number of participants with transfusion of platelets, frozen plasma, prothrombin complex concentrate, cryoprecipitate and/or fibrinogen concentrate. Time: Up to 28 daysDescription: Hospital-free days alive up to day 28
Measure: Number of hospital-free days alive up to day 28 Time: Up to 28 daysDescription: ICU-free days alive up to day 28
Measure: Number of ICU-free days alive up to day 28 Time: Up to 28 daysDescription: Ventilator-free days alive up to day 28
Measure: Number of ventilator-free days alive up to day 28 Time: Up to 28 daysDescription: Venous thromboembolism
Measure: Number of participants with venous thromboembolism Time: Up to 28 daysDescription: Arterial thromboembolism
Measure: Number of participants with arterial thromboembolism Time: Up to 28 daysDescription: Heparin induced thrombocytopenia
Measure: Number of participants with heparin induced thrombocytopenia Time: Up to 28 daysDescription: D-dimer
Measure: Changes in D-dimer up to day 3 Time: Up to day 3