CovidResearchTrials by Shray Alag


CovidResearchTrials 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 (34)


Name (Synonyms) Correlation
drug2425 TDR Wiki 0.30
drug579 Clevudine Wiki 0.30
drug587 Clofazimine Wiki 0.30
drug1222 Interferon beta-1b Wiki 0.30
drug513 Camostat Mesylate Wiki 0.30
drug1231 Intermediate dose thromboprophylaxis Wiki 0.30
drug2515 Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki 0.30
drug1005 Graded exercise test Wiki 0.30
drug581 Clinical assessment Wiki 0.30
drug2473 Test PCR Wiki 0.30
drug936 Fibrin generation markers assays Wiki 0.30
drug2434 TRV027 Wiki 0.30
drug1913 Problem-solving and relationship improvement intervention. Wiki 0.30
drug2486 The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki 0.30
drug590 Cloth Face Mask Wiki 0.30
drug2496 Therapeutic Anticoagulation Wiki 0.30
drug2514 Thrombin generation test assay Wiki 0.30
drug598 Cognitive and behavioral intervention. Wiki 0.30
drug592 Co-mestring (co-coping) Wiki 0.30
drug580 Clinical Examination Wiki 0.30
drug3003 sodium chloride 0.9% Wiki 0.30
drug2325 Standard of Care thromboprophylaxis Wiki 0.30
drug591 Clungene rapid test cassette Wiki 0.30
drug1539 N-95 Respirator Wiki 0.30
drug1974 Quantra System Wiki 0.30
drug2513 Thrombin Generation Assay (TGA) Wiki 0.30
drug1488 Microcrystalline Cellulose, NF Wiki 0.30
drug576 Clazakizumab Wiki 0.27
drug2499 Therapeutic anticoagulation Wiki 0.21
drug2187 Saliva collection Wiki 0.13
drug1645 Normal saline Wiki 0.13
drug315 Baricitinib Wiki 0.11
drug852 Enoxaparin Wiki 0.10
drug1822 Placebo Wiki 0.02

Correlated MeSH Terms (28)


Name (Synonyms) Correlation
D020141 Hemostatic Disorders NIH 1.00
D001778 Blood Coagulation Disorders NIH 1.00
D004211 Disseminated Intravascular Coagulation NIH 0.45
D001997 Bronchopulmonary Dysplasia NIH 0.30
D008595 Menorrhagia NIH 0.30
D006929 Hyperaldosteronism NIH 0.30
D014552 Urinary Tract Infections NIH 0.30
D054559 Hyperphosphatemia NIH 0.30
D004314 Down Syndrome NIH 0.30
D000309 Adrenal Insufficiency NIH 0.30
D007008 Hypokalemia NIH 0.30
D009080 Mucocutaneous Lymph Node Syndrome NIH 0.21
D006470 Hemorrhage NIH 0.21
D001289 Attention Deficit Disorder with Hyperactivity NIH 0.15
D012769 Shock, NIH 0.12
D054556 Venous Thromboembolism NIH 0.11
D006973 Hypertension NIH 0.08
D013923 Thromboembolism NIH 0.08
D004194 Disease NIH 0.05
D016638 Critical Illness NIH 0.04
D011024 Pneumonia, Viral NIH 0.04
D014777 Virus Diseases NIH 0.04
D007239 Infection NIH 0.03
D013577 Syndrome NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D003141 Communicable Diseases NIH 0.03
D018352 Coronavirus Infections NIH 0.02
D011014 Pneumonia NIH 0.02

Correlated HPO Terms (10)


Name (Synonyms) Correlation
HP:0005521 Disseminated intravascular coagulation HPO 0.45
HP:0002905 Hyperphosphatemia HPO 0.30
HP:0002900 Hypokalemia HPO 0.30
HP:0000846 Adrenal insufficiency HPO 0.30
HP:0000132 Menorrhagia HPO 0.30
HP:0000859 Hyperaldosteronism HPO 0.30
HP:0007018 Attention deficit hyperactivity disorder HPO 0.15
HP:0000822 Hypertension HPO 0.08
HP:0001907 Thromboembolism HPO 0.07
HP:0002090 Pneumonia HPO 0.02

There are 11 clinical trials

Clinical Trials


1 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404 Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Menorrhagia In Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Fibrinolysis; Hemorrhage Attention Deficit Hyperactivity Disorder Multisystem Inflammatory Syndrome in Children (MIS-C) Kawasaki Disease Coagulation Disorder Down Syndrome Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Down Syndrome Menorrhagia Hypertension Hemostatic Disorders Mucocutaneous Lymph Node Syndrome Blood Coagulation Disorders Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Disease Syndrome Hemorrhage Attention Deficit Disorder with Hyperactivity
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Adrenal insufficiency Attention deficit hyperactivity disorder Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

2 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

3 Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients

Increased 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

4 COVID-19-associated Coagulopathy: Safety and Efficacy of Prophylactic Anticoagulation Therapy in Hospitalized Adults With COVID-19

This prospective, randomized, open-label, multi-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

5 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)

Coagulopathy 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

6 Randomised Controlled Trial Comparing High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy Not Requiring Invasive Mechanical Ventilation

Randomized, 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

7 Investigating the Relationship Between the Renin Angiotensin System and the Coagulopathy Associated With COVID-19

To 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 day 8 following administration of TRV027 or placebo.

Measure: Coagulopathy associated with COVID-19

Time: Day 1 and Day 8

Secondary Outcomes

Description: Absolute D-Dimer - (Fibrin Equivalent units)

Measure: Markers of dysregulation of coagulation system

Time: Day 1 and Day 8

Description: platelet count (E9 /L)

Measure: Markers of dysregulation of coagulation system

Time: Day 1, 3, Day 5 and Day 8

Description: aPTT (Activated Partial Thromboplastin time) - seconds

Measure: Markers of dysregulation of coagulation system

Time: Day 1, 3, Day 5 and Day 8

Description: INR - (calculated as a ratio from aPTT)

Measure: Markers of dysregulation of coagulation system

Time: Day 1, 3, Day 5 and Day 8

Description: fibrinogen (g/L)

Measure: Markers of dysregulation of coagulation system

Time: Day 1, 3, Day 5 and Day 8

Description: Ferritin Ug/mL

Measure: Markers of dysregulation of coagulation system

Time: Day 1, 3, Day 5 and Day 8

Description: Plasma Renin Mass and activity (ng/ml/h)

Measure: Markers of dysregulation of RAS

Time: Day 3, Day 5 and Day 8

Description: Total bilirubin (umol/L)

Measure: Markers of Haemolysis/inflammation

Time: Day 1, 3, Day 5 and Day 8

Description: LDH u/L

Measure: Markers of Haemolysis/Inflammation

Time: Day 3, Day 5 and Day 8

Description: Haptoglobin g/L

Measure: Markers of Haemolysis/inflammation

Time: Day 1, 3, Day 5 and Day 8

Description: Pro-calcitonin ug/L

Measure: Markers of Inflammation (bacterial sepsis)

Time: day 1, 3, 5 and 8

Description: Creatinine (umol/L)

Measure: Markers of organ dysregulation - kidney

Time: Day 1, 3, Day 5 and Day 8

Description: BNP (B-type natriuetic Peptide) ng/L

Measure: Markers of dysregulation of cardiovascular system

Time: Day 1, 3, Day 5 and Day 8

Description: Troponin ng/L

Measure: Markers of dysregulation of cardiovascular system

Time: Day 1, 3, Day 5 and Day 8

Description: glucose mmol/L

Measure: marker of dysregulation of endocrine system

Time: Day 1, 3, Day 5 and Day 8

8 The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications

The primary aim of this study is to determine whether Camostat mesylate reduces SARS-COV-2 associated coagulopathy. Additional aims are to determine the effect of Camostat mesylate on SARS-COV-2 associated myocardial injury, to assess duration of hypoxia or intubation, to evaluate the length of intensive care unit and hospital stay, and assess mortality rates.

NCT04435015 Coagulopathy Cardiovascular Complication COVID-19 Drug: Camostat Mesylate Drug: Microcrystalline Cellulose, NF
MeSH:Hemostatic Disorders Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade

Primary Outcomes

Description: The sum percent change in D-Dimer over 7 days will be compared to day 1

Measure: Percent change in plasma D-Dimer

Time: 7 days

Secondary Outcomes

Description: The first assessment on mortality and complications will be carried out 3 months after the start of the study.

Measure: Overall Safety and adverse event

Time: 3 months

Description: Percent change in fibrinogen over 7 days compared to day 1

Measure: Change in plasma Fibrinogen levels

Time: 7 days

Description: Percent change in troponin over 7 days compared to day 1

Measure: Change in plasma troponin

Time: 7 days

Description: New onset cardiomyopathy defined by a reduction of EF by greater than 10% or less than 45% will be measured

Measure: New onset cardiomyopathy

Time: 7 days

Description: Days with hypoxia (Room Air O2 Sat<93%) or days intubated

Measure: Duration of intubation

Time: 7 days

Description: The number of days in the intensive care unit

Measure: Length of stay in the intensive care unit

Time: 28 days

Description: The number of days since admission to discharge

Measure: Time to discharge from hospital

Time: 30 days

Description: The ocurrence of major adverse cardiovascular events (MACE): MI, stroke, CHF, PCI, death from cardiovascular disease will be studied.

Measure: Occurrence of major adverse cardiovascular events

Time: 7 days

9 Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19

Published papers evaluating coagulopathy on COVID-19 patients indicate a higher incidence of thromboembolic events, sometimes, as high as 20%. Such events increase ICU admissions and are associated with death. Considering the importance of thromboembolic events concurring to deteriorate clinical state, we propose to conduct a parallel pragmatic open-label randomized controlled trial to determine the effect of therapeutic anticoagulation compared to standard care in hospitalized patients with COVID-19 and with low oxygen saturation.

NCT04444700 COVID Coronavirus Infection Severe Acute Respiratory Syndrome Thromboe Thromboembolism, Venous Anticoagulants and Bleeding Disorders Drug: Therapeutic anticoagulation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Thromboembolism Hemostatic Disorders Venous Thromboembolism Blood Coagulation Disorders
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Thromboembolism

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 main outcome

Time: up to 28 days

Secondary Outcomes

Description: All-cause death

Measure: All-cause death

Time: 28 days

Description: Composite outcome of ICU admission or all-cause death

Measure: Composite outcome of ICU admission or all-cause death

Time: 28 days

Description: Major bleeding

Measure: Major bleeding

Time: 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: 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: 28 days

Description: Hospital-free days alive up to day 28

Measure: Number of hospital-free days alive up to day 28

Time: 28 days

Description: ICU-free days alive up to day 28

Measure: Number of ICU-free days alive up to day 28

Time: 28 days

Description: Ventilator-free days alive up to day 28

Measure: Number of ventilator-free days alive up to day 28

Time: 28 days

Description: Venous thromboembolism

Measure: Number of participants with venous thromboembolism

Time: 28 days

Description: Arterial thromboembolism

Measure: Number of participants with arterial thromboembolism

Time: 28 days

Description: Heparin induced thrombocytopenia

Measure: Number of participants with heparin induced thrombocytopenia

Time: 28 days

10 Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients

This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.

NCT04460664 COVID Disseminated Intravascular Coagulation Coagulation Disorder Diagnostic Test: Quantra System
MeSH:Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

Primary Outcomes

Description: Coagulation function assessed by the Quantra

Measure: Quantra Clot Time results

Time: Within 24 hours of admission to the hospital

Description: Coagulation function assessed by the Quantra

Measure: Quantra Clot Time results

Time: 48 to 72 hours after transfer to ICU

Description: Coagulation function assessed by the Quantra

Measure: Quantra Clot Time results

Time: 1 to 24 hours prior to discharge from hospital

Description: Coagulation function assessed by the Quantra

Measure: Quantra Clot Stiffness results

Time: Upon arrival at hospital

Description: Coagulation function assessed by the Quantra

Measure: Quantra Clot Stiffness results

Time: 48 to 72 hours after transfer to ICU

Description: Coagulation function assessed by the Quantra

Measure: Quantra Clot Stiffness results

Time: 1 to 24 hours prior to discharge from hospital

11 Uppföljning av Patienter Som intensivvårdats för COVID-19

The study will follow COVID-19 patients who required intensive care after 3-6 months and one year after discharge from the ICU with functional level as well as organ function to assess recovery after COVID-19. Blood and urine will be collected for biobanking.

NCT04474249 COVID19 ARDS AKI Circulatory Failure Coagulation Di Coagulation Disorder Inflammatory Response
MeSH:Hemostatic Disorders Blood Coagulation Disorders Shock
HPO:Abnormality of coagulation Abnormality of the coagulation cascade

Primary Outcomes

Description: Death

Measure: Mortality

Time: Within 90 days after admission to ICU.

Description: Death

Measure: Mortality

Time: Within 1 year after admission to ICU.

Description: Return of renal function measured as CKD stage.

Measure: Renal recovery

Time: At follow-up three to six months after ICU discharge.

Description: Return of renal function measured as CKD stage.

Measure: Renal recovery

Time: At follow-up one year after ICU discharge.

Description: Respiratory function as assessed by a clinician

Measure: Respiratory recovery

Time: Three to six months from discharge from ICU

Description: 6 min walk test

Measure: Working capacity

Time: Three to six months from discharge from ICU

Description: Quality of Life assessed using the 36-item short form survey by RAND.

Measure: Quality of life score

Time: Three to six months from discharge from ICU

Description: Cognitive screening using the Montreal Cognitive Assessment.

Measure: Cognitive recovery

Time: Three to six months from discharge from ICU

Description: Screening for frailty using the Clinical Frailty Scale-9.

Measure: Frailty

Time: Three to six months from discharge from ICU

Description: Screening of functional level for Activities of Daily Life using the 5-level EQ-5D.

Measure: Activities of Daily Life

Time: Three to six months from discharge from ICU

Description: Screening for anxiety using the Generalised Anxiety Disorder 7-item scale.

Measure: Anxiety

Time: Three to six months from discharge from ICU

Description: Screening for depression using the Patient Health Questionnaire 9.

Measure: Depression

Time: Three to six months from discharge from ICU

Description: Neurological function as assessed by a clinician

Measure: Neurological recovery

Time: Three to six months from discharge from ICU


HPO Nodes