Covid 19 Research using Clinical Trials (Home Page)
Report for D020141: Hemostatic Disorders NIH
(Synonyms: Hemostatic Disorders)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (23)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug308 | Chloroquine Wiki | 0.43 |
| drug1294 | Standard supportive care Wiki | 0.41 |
| drug514 | Fibrin generation markers assays Wiki | 0.41 |
| drug1393 | Thrombin Generation Assay (TGA) Wiki | 0.41 |
| drug1395 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.41 |
| drug1380 | Therapeutic Anticoagulation Wiki | 0.41 |
| drug315 | Chlorpromazine Injection Wiki | 0.41 |
| drug694 | Intermediate dose thromboprophylaxis Wiki | 0.41 |
| drug1657 | sodium chloride 0.9% Wiki | 0.41 |
| drug1284 | Standard of Care thromboprophylaxis Wiki | 0.41 |
| drug1347 | TRV027 Wiki | 0.41 |
| drug1394 | Thrombin generation test assay Wiki | 0.41 |
| drug715 | Ivermectin Wiki | 0.29 |
| drug618 | Hydroxychloroquine Sulfate Loading Dose Wiki | 0.29 |
| drug619 | Hydroxychloroquine Sulfate Regular dose Wiki | 0.29 |
| drug310 | Chloroquine Sulfate Wiki | 0.29 |
| drug314 | Chloroquine phosphate Wiki | 0.29 |
| drug1359 | Telemedicine Wiki | 0.24 |
| drug442 | Doxycycline Wiki | 0.24 |
| drug889 | Nitazoxanide Wiki | 0.20 |
| drug472 | Enoxaparin Wiki | 0.18 |
| drug591 | Hydroxychloroquine Wiki | 0.04 |
| drug1016 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001778 | Blood Coagulation Disorders NIH | 1.00 |
| D004211 | Disseminated Intravascular Coagulation NIH | 0.47 |
| D016638 | Critical Illness NIH | 0.08 |
| D011024 | Pneumonia, Viral NIH | 0.06 |
| D014777 | Virus Diseases NIH | 0.05 |
| D011014 | Pneumonia NIH | 0.03 |
| D007239 | Infection NIH | 0.03 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001928 | Abnormality of coagulation HPO | 0.82 |
| HP:0005521 | Disseminated intravascular coagulation HPO | 0.47 |
There are 6 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
5 Randomised Controlled Trial Comparing High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy Not Requiring Invasive Mechanical Ventilation
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 3Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation. Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are: 1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay: 1. Death 2. Acute Myocardial Infarction [AMI] 3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] 4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation 5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation 2. Similar in terms of major bleeding risk during hospital stay
NCT04408235 COVID Pneumonia, Viral Coagulation Disorder Drug: Enoxaparin MeSH:Pneumonia, Viral Pneumonia Hemostatic Disorders Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Pneumonia
Primary Outcomes
Description: Death
Acute Myocardial Infarction [AMI]
Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
Measure: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: Time: through study completion, up to 30 days
Secondary Outcomes
Description: Death
Acute Myocardial Infarction [AMI]
Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]
Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation
Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
Improvement of laboratory parameters of disease severity, including:
D-dimer level
Plasma fibrinogen levels
Mean Platelet Volume
Lymphocyte/Neutrophil ratio
IL-6 plasma levels
Measure: Any of the following events occurring within the hospital stay Time: through study completion, up to 30 days
Description: Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation.
Measure: Mortality at 30 days Time: 30 days
6 Investigating the Relationship Between the Renin Angiotensin System and the Coagulopathy Associated With COVID-19
Primary Outcomes
Description: Death Acute Myocardial Infarction [AMI] Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation
Measure: Clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: Time: through study completion, up to 30 daysSecondary Outcomes
Description: Death Acute Myocardial Infarction [AMI] Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients, who are in standard oxygen therapy by delivery interfaces at randomisation Need for invasive mechanical ventilation for patients, who are in non-invasive mechanical ventilation at randomisation Improvement of laboratory parameters of disease severity, including: D-dimer level Plasma fibrinogen levels Mean Platelet Volume Lymphocyte/Neutrophil ratio IL-6 plasma levels
Measure: Any of the following events occurring within the hospital stay Time: through study completion, up to 30 daysDescription: Information about patients' status will be sought in those who are discharged before 30 days on Day 30 from randomisation.
Measure: Mortality at 30 days Time: 30 daysTo determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)
NCT04419610 COVID Biological: TRV027 Other: sodium chloride 0.9% MeSH:Hemostatic Disorders Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade
Primary Outcomes
Description: Mean change from baseline D-dimer at 7 days following administration of TRV027 or placebo.
Measure: Coagulopathy associated with COVID-19 Time: Day 3, Day 5 and Day 7
Secondary Outcomes
Description: Absolute D-Dimer - (Fibrin Equivalent units)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admission
Description: platelet count (E9 /L)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admission
Description: aPTT (Activated Partial Thromboplastin time) - seconds
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admission
Description: INR - (calculated as a ratio from aPTT)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admission
Description: fibrinogen (g/L)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admission
Description: Plasma Renin Mass and activity (ng/ml/h)
Measure: Markers of dysregulation of RAS Time: Assessed at 3,5 and 7 days during admission.
Description: bilirubin (umol/L)
Measure: Markers of Haemolysis/inflammation Time: Assessed at 3,5 and 7 days during admission.
Description: LDH u/L
Measure: Markers of Haemolysis/Inflammation Time: Assessed at 3,5 and 7 days during admission.
Description: Haptoglobin g/L
Measure: Markers of Haemolysis/inflammation Time: Assessed at 3,5 and 7 days during admission.
Description: Creatinine (umol/L)
Measure: Markers of organ dysregulation - kidney Time: Assessed at 3,5 and 7 days during admission.
Description: BNP (B-type natriuetic Peptide) ng/L
Measure: Markers of dysregulation of cardiovascular system Time: Assessed at 3,5 and 7 days during admission.
Description: Troponin ng/L
Measure: Markers of dysregulation of cardiovascular system Time: Assessed at 3,5 and 7 days during admission.
HPO Nodes
Primary Outcomes
Description: Mean change from baseline D-dimer at 7 days following administration of TRV027 or placebo.
Measure: Coagulopathy associated with COVID-19 Time: Day 3, Day 5 and Day 7Secondary Outcomes
Description: Absolute D-Dimer - (Fibrin Equivalent units)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admissionDescription: platelet count (E9 /L)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admissionDescription: aPTT (Activated Partial Thromboplastin time) - seconds
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admissionDescription: INR - (calculated as a ratio from aPTT)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admissionDescription: fibrinogen (g/L)
Measure: Markers of dysregulation of coagulation system Time: Assessed at 3,5 and 7 days during admissionDescription: Plasma Renin Mass and activity (ng/ml/h)
Measure: Markers of dysregulation of RAS Time: Assessed at 3,5 and 7 days during admission.Description: bilirubin (umol/L)
Measure: Markers of Haemolysis/inflammation Time: Assessed at 3,5 and 7 days during admission.Description: LDH u/L
Measure: Markers of Haemolysis/Inflammation Time: Assessed at 3,5 and 7 days during admission.Description: Haptoglobin g/L
Measure: Markers of Haemolysis/inflammation Time: Assessed at 3,5 and 7 days during admission.Description: Creatinine (umol/L)
Measure: Markers of organ dysregulation - kidney Time: Assessed at 3,5 and 7 days during admission.Description: BNP (B-type natriuetic Peptide) ng/L
Measure: Markers of dysregulation of cardiovascular system Time: Assessed at 3,5 and 7 days during admission.Description: Troponin ng/L
Measure: Markers of dysregulation of cardiovascular system Time: Assessed at 3,5 and 7 days during admission.