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D014947: Wounds and Injuries

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (63)


Name (Synonyms) Correlation
drug53 3D Telemedicine Wiki 0.21
drug2778 Racial Inequality Highlighted Wiki 0.18
drug2751 Quinquina-Stevia/Azythromycin Wiki 0.18
Name (Synonyms) Correlation
drug294 Assessing antibody responses, neutralizing capacity and memory B-cell function Wiki 0.18
drug376 BIO101 Wiki 0.18
drug15 0.9% Sodium-chloride Wiki 0.18
drug339 Ayurvedic Kadha Wiki 0.18
drug1982 Medical Record Review Wiki 0.18
drug2231 Non interventional study Wiki 0.18
drug2158 Nebulised heparin Wiki 0.18
drug2564 Placebo videos Wiki 0.18
drug56 4Plants/Azythromycin Wiki 0.18
drug1784 LSALT peptide Wiki 0.18
drug1928 MRI scans Wiki 0.18
drug621 COVID-19 barrier box Wiki 0.18
drug86 AMA Acknowledgement Drug Pricing Wiki 0.18
drug71 ACE inhibitor, angiotensin receptor blocker Wiki 0.18
drug149 Acknowledgement Racial Injustice AMA Wiki 0.18
drug3128 Sodium bicarbonate Wiki 0.18
drug184 African American Sender in Informational Videos. Wiki 0.18
drug3922 mRNA in urine test Wiki 0.18
drug3667 White Sender in Informational Videos Wiki 0.18
drug606 COVID-19 PCR Wiki 0.18
drug697 Cannabis, Medical Wiki 0.18
drug3963 non applicable Wiki 0.18
drug3570 VIB7734 Wiki 0.18
drug183 African American Sender Acknowledgement Wiki 0.18
drug65 AAZ Covid-19 rapid test Wiki 0.18
drug934 Covid-19 Standard of Care Wiki 0.18
drug74 ACEIs Wiki 0.18
drug2952 SBI-101 Wiki 0.18
drug3536 Ultrasound lung imaging as part of FAST+ evaluation Wiki 0.18
drug1557 Hydroxychloroquine/Azithromycine Wiki 0.18
drug1704 Intervention training: Wiki 0.18
drug3666 White Sender in Acknowledgement Wiki 0.18
drug3320 Tacrolimus Wiki 0.18
drug3626 VitalTalk communication skills training Wiki 0.18
drug75 ACP Decisions Video Program Wiki 0.18
drug1834 Liver function tests Wiki 0.18
drug753 Chiropractic care Wiki 0.18
drug79 ADM03820 Wiki 0.18
drug1836 Liver injury Wiki 0.18
drug2213 No Racial Inequality Highlighting Wiki 0.18
drug558 CERC-002 Wiki 0.18
drug84 AKS-452 Wiki 0.18
drug4067 semaglutide Wiki 0.18
drug3261 Supportive Trauma Exposure Preparation Program Wiki 0.18
drug620 COVID-19 antigen and antibody tests, and influenza rapid test Wiki 0.18
drug47 2D Telemedicine Wiki 0.13
drug313 Atorvastatin Wiki 0.13
drug910 Conventional treatment Wiki 0.13
drug1777 L-ascorbic acid Wiki 0.13
drug231 Angiotensin-(1-7) Wiki 0.13
drug130 AZD7442 Wiki 0.11
drug1437 Heparin Wiki 0.09
drug2253 Normal saline Wiki 0.09
drug2768 RLS-0071 Wiki 0.09
drug2490 Placebo Wiki 0.06
drug210 Anakinra Wiki 0.06
drug808 Colchicine Wiki 0.05
drug2032 Methylprednisolone Wiki 0.05
drug2215 No intervention Wiki 0.04
drug3191 Standard of Care Wiki 0.03

Correlated MeSH Terms (42)


Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.39
D000070642 Brain Injuries, Traumatic NIH 0.26
D001930 Brain Injuries, NIH 0.24
Name (Synonyms) Correlation
D055370 Lung Injury NIH 0.23
D013119 Spinal Cord Injuries NIH 0.21
D000070627 Chronic Traumatic Encephalopathy NIH 0.18
D013226 Status Epilepticus NIH 0.18
D002543 Cerebral Hemorrhage NIH 0.18
D013345 Subarachnoid Hemorrhage NIH 0.18
D005879 Tourette Syndrome NIH 0.18
D015428 Myocardial Reperfusion Injury NIH 0.18
D015427 Reperfusion Injury NIH 0.18
D003424 Crohn Disease NIH 0.18
D000690 Amyotrophic Lateral Sclerosis NIH 0.13
D012640 Seizures NIH 0.13
D016472 Motor Neuron Disease NIH 0.13
D006526 Hepatitis C NIH 0.13
D006470 Hemorrhage NIH 0.11
D001714 Bipolar Disorder NIH 0.11
D055371 Acute Lung Injury NIH 0.09
D005356 Fibromyalgia NIH 0.09
D000755 Anemia, Sickle Cell NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08
D001927 Brain Diseases NIH 0.08
D010300 Parkinsonian NIH 0.07
D015212 Inflammatory Bowel Diseases NIH 0.07
D012598 Scoliosi NIH 0.06
D009103 Multiple Sclerosis NIH 0.06
D059350 Chronic Pain NIH 0.06
D020521 Stroke NIH 0.05
D040921 Stress Disorders, Traumatic NIH 0.04
D004194 Disease NIH 0.04
D013577 Syndrome NIH 0.04
D013313 Stress Disorders, Post-Traumatic NIH 0.03
D002318 Cardiovascular Diseases NIH 0.03
D004630 Emergencies NIH 0.03
D016638 Critical Illness NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D011014 Pneumonia NIH 0.02
D003141 Communicable Diseases NIH 0.01
D007239 Infection NIH 0.01

Correlated HPO Terms (15)


Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.39
HP:0002133 Status epilepticus HPO 0.18
HP:0002138 Subarachnoid hemorrhage HPO 0.18
Name (Synonyms) Correlation
HP:0001342 Cerebral hemorrhage HPO 0.18
HP:0100280 Crohn's disease HPO 0.18
HP:0006802 Abnormal anterior horn cell morphology HPO 0.13
HP:0100754 Mania HPO 0.13
HP:0007354 Amyotrophic lateral sclerosis HPO 0.13
HP:0001250 Seizure HPO 0.11
HP:0001298 Encephalopathy HPO 0.08
HP:0002037 Inflammation of the large intestine HPO 0.07
HP:0012532 Chronic pain HPO 0.06
HP:0001297 Stroke HPO 0.05
HP:0001626 Abnormality of the cardiovascular system HPO 0.03
HP:0002090 Pneumonia HPO 0.02

Clinical Trials

Navigate: Correlations   HPO

There are 30 clinical trials


1 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years
2 Acute Kidney Injury in Patients Hospitalized With COVID-19 in Wuhan, China: a Single-center Retrospective Observational Study

The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.

NCT04316299
Conditions
  1. COVID-19
  2. Acute Kidney Injury
  3. Kidney Function
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: the incidence of Acute Kidney Injury

Measure: Rate of Acute Kidney Injury

Time: From date of admission until the date of discharge or death from any cause, up to 60 days

Secondary Outcomes

Description: death from any cause in the hospital

Measure: Rate of Death

Time: From date of admission until the date of death from any cause, up to 60 days

Description: days from admission to discharge or death

Measure: the length of hospital stay

Time: From date of admission until the date of discharge or death from any cause, up to 60 days
3 The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

The current COVID-19 pandemic is providing healthcare organizations with considerable challenges and opportunities for rapid cycle improvement efforts, in diagnostic and patient management arenas. Healthcare providers are tasked with limiting the use of personal protective equipment while minimizing unnecessary exposures to the virus. Results from real-time PCR tests to detect active COVID-19 infections may not be available in a timely fashion during emergent trauma assessments. Since the start of the COVID-19 pandemic, a rapidly expanding body of literature has identified a pattern of imaged lung abnormalities with CT and ultrasound (US) characteristic of an active viral infection. US evaluation provides a reliable, portable, and reproducible way of evaluating acute patients in a real time setting. During initial trauma evaluations, patients may also receive adjunct imaging modalities like the Focused Assessment with Sonography in Trauma (FAST) exam designed to discover life threatening findings that may require urgent interventions. We therefore propose a study expanding on the current FAST adjunct evaluation in the trauma bay that may include lung parenchyma imaging at the initial assessment to help stratify patients into low or high-risk groups for active COVID-19 infections. We believe the use of point of care US in the initial assessment of the trauma patient may help identify potentially infected individuals and aid ED providers to best directing subsequent laboratory and imaging evaluations for these patients, while further directing the necessary protective measures for additional team members involved in the care of the injured patient.

NCT04340479
Conditions
  1. COVID
  2. Trauma
  3. Ultrasound
Interventions
  1. Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation
MeSH:Wounds and Injuries

Primary Outcomes

Description: Will correlate FAST+ pulmonary findings and published CT findings noted in active COVID infection to determine if FAST+ is a suitable diagnostic tool in detecting active COVID infection. Plan to use FAST+ imaging findings to stratify patients into low or high-risk COVID-19 infection groups.

Measure: Correlation of FAST+ pulmonary findings with active COVID infection

Time: 12 months

Secondary Outcomes

Description: Exploratory outcomes will focus on description of additional ancillary findings of the FAST+ examination in those patients who later are determined to be COVID-19 positive compared to those determined to be COVID-19 negative (e.g., patterns of pleural space disease).

Measure: Description of additional ancillary findings of the FAST+ examination among infected and non-infected patients

Time: 12 months
4 Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19

The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.

NCT04341038
Conditions
  1. COVID-19
  2. Lung Injury
Interventions
  1. Drug: Tacrolimus
  2. Drug: Methylprednisolone
MeSH:Lung Injury Wounds and Injuries

Primary Outcomes

Description: Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300; Respiratory rate ≤ 24 rpm

Measure: Time to reach clinical stability

Time: 28 days

Secondary Outcomes

Description: days

Measure: Time to reach an afebrile state for 48 hours.

Time: 56 days

Description: days

Measure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300

Time: 56 days

Description: days

Measure: Time to reach FR ≤ 24 rpm for 48 hours

Time: 56 days

Description: days

Measure: Time to normalization of D-dimer (<250 ug / L)

Time: 56 days

Description: days

Measure: Time until PCR normalization (<5mg / L).

Time: 56 days

Description: days

Measure: Time until normalization of ferritin (<400ug / L)

Time: 56 days

Description: viral load

Measure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR

Time: 56 days

Description: days

Measure: Time until hospital discharge

Time: 56 days

Description: days

Measure: Need for ventilatory support devices

Time: 56 days

Description: days

Measure: Duration that it is necessary to maintain ventilatory support.

Time: 56 days

Description: days

Measure: COVID-19 mortality

Time: 56 days

Description: days

Measure: all-cause mortality

Time: 56 days

Description: cytokines quantification technique by Luminex

Measure: Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission

Time: 56 days

Description: IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilance

Measure: Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone.

Time: 56 days
5 SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)

This study will the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19.

NCT04344184
Conditions
  1. COVID-19
  2. Lung Injury, Acute
  3. Kidney Injury
Interventions
  1. Drug: L-ascorbic acid
  2. Other: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Description: COVID disease status will be measured by the 9-point (from 0 to 8) World Health Organization (WHO) ordinal scale for disease improvement at 28 days.

Measure: Change in COVID disease status

Time: Baseline to 28, 60 and 90 days

Secondary Outcomes

Description: Change in serum oxalate levels

Measure: Renal safety biomarkers - serum oxalate

Time: On days 5,7 and 14

Description: Microscopic analysis of urine for presence of oxalate stones

Measure: Renal safety biomarkers - urine oxalate stones

Time: On days 5,7 and 14

Description: 24-hour urine oxalate levels

Measure: Renal safety biomarkers - 24-hour urine oxalate levels

Time: On days 5,7 and 14

Description: Renal-failure free days, with AKI defined by the KDIGO criteria

Measure: Acute Kidney Injury-free days

Time: On day 28, 90

Description: Mortality by all causes

Measure: Number of deaths

Time: On day 28, 60 and 90 days

Description: Difference in plasma ferritin levels in ng/mL, compared to baseline levels

Measure: Change in plasma ferritin levels

Time: Days 1-7 compared with baseline

Description: Difference in D-dimer levels in mcg/mL, compared to baseline levels

Measure: Change in plasma D-dimer levels

Time: Days 1-7 compared with baseline

Description: Difference in lactate dehydrogenase (LDH) levels in units/L, compared to baseline levels

Measure: Change in serum lactate dehydrogenase (LDH) levels

Time: Days 1-7 compared with baseline

Description: Difference in plasma IL-6 levels in pg/mL, compared to baseline levels

Measure: Change in plasma IL-6 levels

Time: Days 1-7 compared with baseline

Description: Respiratory failure defined as resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation

Measure: Proportion of patients alive and free of respiratory failure

Time: At 28-days

Description: Percentage of patients alive and not requiring invasive mechanical ventilation

Measure: Proportion of patients alive and free of invasive mechanical ventilation

Time: At 28-days
6 Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors

Coronavirus disease was first diagnosed in December 2019, in the city of Wuhan, China. The World Health Organization recently declared coronavirus disease 2019 (COVID-19) as a pandemic. The infection is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is a single-stranded RNA virus, which in humans causes mild respiratory symptoms and generally has a good prognosis. However, in a certain group of patients it manifests as severe pneumonia, respiratory distress syndrome, multiple organ dysfunction and death. The factors associated with a worse prognosis are older than 60 years, the presence of diabetes, cardiovascular disease and obesity. According to studies carried out in the Eastern world, the prevalence of liver injury in patients with COVID-19 disease varies between 14% and 53%, being more prevalent in patients with severe symptoms of COVID-19 disease. It is not really known whether the liver involvement of patients with SARS-CoV-2 infection is secondary to the direct effect of the virus on the liver. One of the mechanisms of action of SARS-CoV-2 is through the binding to the angiotensin-converting enzyme receptor, which is present in cholangiocytes, this could explain its excretion in faeces. However, liver injury could be due to the immune response generated in the body by the virus with systemic inflammatory response syndrome and the release of inflammatory cytokines such as IL6, generating direct cytopathic damage to the liver. On the other hand, it could be the product of hepatotoxic drugs administered during hospitalization, such as antibiotics, antivirals or non-steroidal anti-inflammatory drugs. Liver biopsy described microvacuolar steatosis, and a mild portal and lobular inflammatory infiltrate . Therefore, the aim this study is to assess the prevalence of liver complications (liver injury, decompensation of cirrhosis) in patients diagnosed with COVID-19 in Latin America. As secondary objectives, the investigators will describe the clinical characteristics of COVID-19 disease and identify risk factors associated with poor prognosis,

NCT04358380
Conditions
  1. Liver Injury
Interventions
  1. Other: Liver injury
MeSH:Wounds and Injuries

Primary Outcomes

Description: Hospitalized patients with COVD-19 who developed liver injury

Measure: Liver injury in patients with COVID-19

Time: through study completion, an average of 6 months

Secondary Outcomes

Description: Factors associated with worse outcome

Measure: Prognostic factors associated with death

Time: through study completion, an average of 6 months

Description: Description of patients hospitalized with COVID-19

Measure: Clinical characteristics of patients who developed liver injury

Time: through study completion, an average of 6 months
7 Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19

The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

NCT04386564
Conditions
  1. COVID-19
  2. Kidney Injury
Interventions
  1. Diagnostic Test: mRNA in urine test
MeSH:Wounds and Injuries

Primary Outcomes

Description: estimated glomerular filtration rate (eGFR), ml/min, in groups with mild, moderate and severe COVID-19

Measure: The effect of COVID-19 severity on the severity of renal failure

Time: 2 months

Secondary Outcomes

Description: viral RNA concentration in urine, ME/ml

Measure: The expression of viral RNA in the urine with the severity of renal failure

Time: 2 months

Description: albumine excretion with urine, g/ml

Measure: The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure

Time: 2 months

Description: estimated glomerular filtration rate (eGFR), ml/min

Measure: Assessment of the severity of renal impairment in patients who died from COVID-19

Time: 2 months

Description: Duration of viral RNA detection in urine by PCR, weeks

Measure: Estimation of the duration of urinary viral RNA isolation in patients undergoing COVID-19

Time: 2 months

Description: expression of ACE-2 by imminohistochemistry at autopsy specimen

Measure: Expression of ACE-2 receptors in the kidneys of patients with renal failure who died from COVID-19

Time: 2 months
8 Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury

Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19

NCT04397510
Conditions
  1. Covid-19
  2. ARDS, Human
  3. Acute Lung Injury
Interventions
  1. Drug: Heparin
  2. Drug: 0.9% Sodium-chloride
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Measure: Mean daily PaO2 to FiO2 ratio

Time: 10 days

Secondary Outcomes

Measure: Duration of mechanical ventilation

Time: 30 days

Measure: ICU length of stay

Time: 30 days

Measure: Mortality Rate

Time: 30 days

Measure: Incidence of adverse drug events

Time: 10 days
9 Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19

The study will analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between high-sensitivity troponin I (TnI) levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.

NCT04397939
Conditions
  1. COVID-19
  2. Myocardial Reperfusion Injury
  3. Cardiovascular Diseases
MeSH:Cardiovascular Diseases Reperfusion Injury Myocardial Reperfusion Injury Wounds and Injuries
HPO:Abnormality of the cardiovascular system

Primary Outcomes

Description: Number of death during hospitalization

Measure: Number of In-Hospital Death

Time: During hospitalization, average 2-3 weeks

Secondary Outcomes

Description: Length of stay in the hospital

Measure: Length of Stay

Time: During hospitalization, average 2-3 weeks

Description: Successful treatment will be defined by two consecutive negative tests for COVID-19

Measure: Number of Successful Treatment

Time: During hospitalization, average 2-3 weeks
10 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy (RRT) on Day 28. The need for continued RRT at Day 28 will be defined as either dialysis in the past 3 days (Day 26, 27, or 28) or an eGFR on Day 28 <10 mL/min/1.73 m2.

NCT04402957
Conditions
  1. COVID
  2. Severe Acute Respiratory Syndrome
  3. Sars-CoV2
  4. Acute Kidney Injury
Interventions
  1. Drug: LSALT peptide
  2. Drug: Placebo
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Acute Kidney Injury Syndrome Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: To evaluate the efficacy of intravenous LSALT peptide plus standard of care to prevent the progression of COVID-19 to mild, moderate or severe ARDS, acute kidney injury, cardiomyopathy, acute liver injury, coagulopathy, or death in patients infected with SARS-CoV-2 compared with placebo plus standard of care.

Measure: Development of Acute Respiratory Distress Syndrome (ARDS) and Other Organ Injuries

Time: 28 days

Secondary Outcomes

Description: High-frequency oscillatory ventilation, with its rapid delivery of low tidal volumes and a respiratory rate in the range of 60 to 900 breaths/minute, has also been utilized in ARDS patients.

Measure: Ventilation-free days

Time: 28 days

Description: Oxygen therapy provided as non-invasive therapy for ARDS patients.

Measure: Time on nasal cannula or oxygen masks

Time: 28 days

Description: 28 day mortality - all cause and attributable

Measure: 28 day mortality - all cause and attributable

Time: 28 days

Description: ICU and hospitalization length of stay (days)

Measure: ICU and hospitalization length of stay (days)

Time: 28 days

Description: Swab (nasopharyngeal, nasal, throat, sputum, or lower respiratory tract) at baseline (Day 1) and every 3 days thereafter until eradication → virologic clearance rate

Measure: SARS-CoV2 testing

Time: 28 days

Description: Extracorporeal membrane oxygenation (ECMO) is often used for severe ARDS to allow lung healing/repair and reverse respiratory failure.

Measure: Need and duration for extracorporeal membrane oxygenation (ECMO)

Time: 28 days

Description: Vasopressor free days

Measure: Vasopressor free days

Time: 28 days

Description: Chest X-rays performed at Baseline, Day 3, at clinical improvement, and end-of-treatment (EOT) and study (EOS) to determine presence of bilateral opacities.

Measure: Radiographic pulmonary assessments

Time: 28 days

Description: Change in daily mMRC dyspnea and SOFA scores (0 to 4) with 4 being the most severe outcome

Measure: Change in modified Medical Research Council (mMRC) dyspnea and Sequential Organ Failure Assessment (SOFA) scores

Time: 28 days

Description: Incidence of other organ (non-lung) disorders

Measure: Incidence of non-lung disorders

Time: 28 days

Description: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline

Measure: Measures of liver dysfunction

Time: 28 days

Description: Change in SCr and eGFR from baseline

Measure: Measures of kidney dysfunction

Time: 28 days

Description: Change in highly-sensitive troponin (hs-troponin) from baseline

Measure: Measures of cardiac dysfunction

Time: 28 days

Description: Change from baseline ACT, aPTT, and/or PT/INR levels

Measure: Measures of coagulopathies

Time: 28 days

Description: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.

Measure: Changes in immunogenic responses

Time: 28 days

Description: Changes in total healthcare costs from admission to discharge between treatment groups.

Measure: Healthcare outcomes

Time: 28 days

Description: Change in serum cytokines including IL-1α, IL-1ß, IL-1ra, IL-5, IL-6, IL-8, IL-12, TNFα, CXCL10/IP10, MCP-3, and ferritin drawn at the same time as LSALT peptide levels

Measure: Molecular changes in pro-inflammatory pathways

Time: 28 days

Description: Pharmacokinetics of LSALT peptide over the study period.

Measure: Pharmacokinetics of LSALT peptide

Time: 28 days
11 Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients. The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.

NCT04406688
Conditions
  1. Acute Kidney Injury
  2. COVID-19
  3. ARDS
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Occurence of moderate or severe AKI

Measure: Occurence of acute kidney injury (AKI)

Time: within 7 days after beginning of moderate or severe ARDS

Secondary Outcomes

Measure: Occurence of transient and persistent AKI

Time: within 7 days after beginning of moderate or severe ARDS

Measure: Occurence of Renal replacement therapy during hospital stay

Time: up to 4 weeks after beginning of moderate or severe ARDS

Measure: Duration of renal replacement therapy

Time: up to 4 weeks after beginning of moderate or severe ARDS

Measure: Mortality

Time: up to 4 weeks after beginning of moderate or severe ARDS

Measure: Duration of mechanical ventilation

Time: up to 4 weeks after beginning of moderate or severe ARDS

Measure: Duration of vasopressor administration

Time: up to 4 weeks after beginning of moderate or severe ARDS

Measure: ICU length of stay

Time: up to 4 weeks after beginning of moderate or severe ARDS

Measure: Hospital length of stay

Time: up to 4 weeks after beginning of moderate or severe ARDS

Other Outcomes

Description: e.g., Analysis of interleukin (IL) 6, IL8

Measure: Add-on analysis: pro- and antiinflammatory mediators

Time: within 7 days after beginning of moderate or severe ARDS
12 A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID 19 Pneumonia and Acute Lung Injury

The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical study of the efficacy and safety of CERC-002, a potent inhibitor of LIGHT, for the treatment of patients with COVID-19 pneumonia who have mild to moderate ARDS. LIGHT is a cytokine in the TNF super family (TNFSF14) which drives inflammation and induces many other cytokines including IL-1, IL-6 and GM-CSF. LIGHT levels have been shown to be elevated in COVID-19 infected patients and inhibiting LIGHT is hypothesized to ameliorate the cytokine storm which has shown to be a major factor in progression of ARDS. The study will assess the efficacy and safety of CERC-002 in patients with severe COVID-19 over a 28 day period as single dose on top of standard of care.

NCT04412057
Conditions
  1. COVID-19 Pneumonia
  2. Acute Lung Injury
  3. ARDS
Interventions
  1. Drug: CERC-002
  2. Drug: Placebo
MeSH:Pneumonia Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries
HPO:Pneumonia

Primary Outcomes

Description: Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation, Extracorporeal membrane oxygenation

Measure: Proportion of patient alive and free of respiratory failure

Time: Baseline to Day 28

Secondary Outcomes

Description: 1-month mortality

Measure: Proportion of subjects who are alive

Time: Baseline to Day 28
13 Tracking Needs of Persons With a Spinal Cord Injury (SCI) During the COVID-19 Pandemic

Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than persons without spinal cord injury (SCI). They often experience a great deal of health needs both on a physiological level as well as a psychosocial level. PwSCI frequently require supports and services to be able to live independently within the community. These services and supports are sometimes difficult to access within the community when the country is operating under regular capacity, in current times with the global COVID-19 pandemic, the challenges for obtaining and accessing supports and services will become much greater. The proposed project aims to identify the specific needs during this time of crisis and to provide referrals and resources to ameliorate those needs by surveying PwSCI in the St. Louis region. The project also hopes to determine if these persons experience isolation during shelter at home orders. PwSCI, who the investigators serve or have served in the past, will be contacted via phone or e-mail once a month for six months and asked to complete a questionnaire that will allow the investigators to track the participant's needs during the COVID-19 pandemic.

NCT04422769
Conditions
  1. Spinal Cord Injuries
MeSH:Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Instrumental Support refers to the perception that people in one's social network are available to provide material or functional aid in completing daily tasks (such as making meals or providing transportation) if needed. This self-report measure for adults (ages 18 and above) is an 8-item calibrated scale.This study will use the measure to determine if people's instrumental support changes during a pandemic.

Measure: NIH Toolbox Instrumental Support Survey - change in instrumental support

Time: Baseline, 3 month and 6 month

Secondary Outcomes

Description: A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever (score of "1"), some of the time (score of "2"), or often (score of "3"). The scores for each individual question can be added together to give you a possible range of scores from 3 to 9. The higher the score the more lonely the person will be. This study will use the measure to determine if people feel socially isolated during a pandemic.

Measure: UCLA (University of California - Los Angeles) 3-item Loneliness Scale - change in social isolation

Time: Baseline, 3 month and 6 month
14 COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

NCT04426071
Conditions
  1. Brain Injuries
  2. Stroke
  3. Spinal Cord Injuries
MeSH:Brain Injuries Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Fear of COVID-19 Questionnaire

Measure: Change in Fear of COVID-19

Time: baseline, 3 months, 6 months

Secondary Outcomes

Description: NeuroQol SF v1.0 - Ability to Part. in SRA

Measure: Change in ability to participate in social roles and activities

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Depression

Measure: Change in depressive symptoms

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Pos. Affect & Well-Being

Measure: Change in positive affect and well-being

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Anxiety

Measure: Change in anxiety

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Fatigue

Measure: Change in fatigue

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol

Measure: Change in emotional and behavioural dyscontrol

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Satisfaction w SRA

Measure: Change in satisfaction with social roles and activities

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Sleep Disturbance

Measure: Change in sleep disturbance

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Stigma

Measure: Change in stigma

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Cognitive Function

Measure: Change in cognitive function

Time: baseline, 3 months, 6 months

Description: 23 questions about strategies to social distance

Measure: Change in social distancing strategies used

Time: baseline, 3 months, 6 months

Description: 22 questions about social distancing

Measure: Change in thoughts and feelings about social distancing

Time: baseline, 3 months, 6 months
15 A Multi-center, Randomized, Case Controlled, Double-blind, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 Therapy) in COVID-19 Subjects With Acute Kidney Injury Receiving Renal Replacement Therapy

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in COVID-19 subjects with Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.

NCT04445220
Conditions
  1. COVID-19
  2. Acute Kidney Injury
Interventions
  1. Biological: SBI-101
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Measure: Safety and tolerability as measured by incidence of IP-related serious adverse events

Time: Outcomes and Serious Adverse Events through Day 180
16 Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.

NCT04445259
Conditions
  1. COVID
  2. Acute Kidney Injury
  3. Critical Illness
MeSH:Acute Kidney Injury Critical Illness Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria

Measure: Incidence of any stage of acute kidney injury

Time: 14 days

Secondary Outcomes

Description: Mortality

Measure: Mortality

Time: 14-day, hospital, and intensive care unit (ICU) mortality

Description: Defined by return of creatinine to < 1.5 times of baseline

Measure: Renal recovery

Time: 14 days

Description: Percentage

Measure: Percentage of patients who receive renal replacement therapy

Time: 14 days

Description: Percentage of participants who are dialysis dependent

Measure: Percentage of participants who are dialysis dependent

Time: Through study completion, an average of 90 days

Description: Days without vasoactive medications and mechanical ventilation

Measure: Free-days of vasoactive medications and mechanical ventilation

Time: Day 30

Description: Length of intensive care unit and hospital stay

Measure: Length of intensive care unit and hospital stay

Time: Through study completion, an average of 90 days

Description: Congestive heart failure, Arrhythmia, Acute respiratory distress syndrome, Septic shock, Acute cardiac injury, pneumonia

Measure: Number of participants with consequences following AKI

Time: Through study completion, an average of 90 days

Description: Time from illness onset to need for mechanical ventilator support

Measure: Time from illness onset to need for mechanical ventilator support

Time: Through study completion, an average of 30 days
17 Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm". The aims of this study are: 1. To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU 2. To identify specific risk factors for AKI 3. To explore pathophysiologic mechanism of AKI during COVID-19 infection

NCT04459975
Conditions
  1. on Occurrence of Acurate Kidney Injury During Intensive Care Unit
  2. Abnormalities of Urinary Analysis
Interventions
  1. Other: Non interventional study
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h

Measure: Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection

Time: 7 months
18 SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative

This study is an observational registry of children with or suspected to have SARS CoV2 (COVID-19) admitted to pediatric intensive care units (PICU). This registry will help describe the prevalence, rate and severity of acute kidney injury (AKI) in children with Severe Acute Respiratory Syndrome Coronavirus-2(SARS CoV2) across the world. The registry will be developed using a point prevalence methodology and then full retrospective review. Once a week, from April through June 2020, data collection will occur in "real-time" to estimate a weekly point prevalence of AKI and renal replacement therapy (RRT). The operational definition of "patients under investigation" (PUIs) will be used to identify the denominator of patients to be studied. The PUIs will be cohorted into SARS CoV2 test positive, test negative, test pending, or test unavailable. The primary aim of this study is to deliver a global, objective data driven analysis of the burden of AKI in virus positive patients or patients under investigation (PUI) who are admitted to the pediatric intensive care unit.

NCT04466306
Conditions
  1. Acute Kidney Injury
  2. COVID
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output

Measure: Acute Kidney Injury (AKI)

Time: 14 days

Secondary Outcomes

Description: Survival to ICU discharge or Day 14

Measure: Survival

Time: 14 days

Description: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy

Measure: Rate of Extracorporeal Therapy Requirement

Time: 14 days

Description: >20% fluid overload as defined as the net fluid balance since ICU admission (in liters) divided by ICU admission weight

Measure: Fluid overload

Time: Day of Enrollment

Description: The exposure of enrolled patients to known nephrotoxic medications, including diuretics

Measure: Rate of nephrotoxic medication exposure

Time: Day of Enrollment
19 The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul

COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

NCT04479124
Conditions
  1. Trauma
  2. Covid19
Interventions
  1. Diagnostic Test: COVID-19 PCR
MeSH:Emergencies Wounds and Injuries

Primary Outcomes

Description: within the study period, trauma patients who admitted to any of the seven study centers will be recorded.

Measure: trauma admissions

Time: 3 months
20 Severe Neurologic Injury Outcomes During COVID-19 Crisis

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

NCT04496076
Conditions
  1. Sars-CoV2
  2. Severe Neurologic Injury
  3. Ischemic Stroke
  4. Hemorrhagic Stroke
  5. Intracerebral Hemorrhage
  6. Subarachnoid Hemorrhage
  7. Traumatic Brain Injury
  8. Status Epilepticus
MeSH:Stroke Brain Injuries Brain Injuries, Traumatic Subarachnoid Hemorrhage Cerebral Hemorrhage Status Epilepticus Hemorrhage Wounds and Injuries
HPO:Cerebral hemorrhage Status epilepticus Stroke Subarachnoid hemorrhage

Primary Outcomes

Measure: In-hospital Mortality

Time: At hospital discharge, approximately 1 month

Measure: 30-day mortality

Time: 30 days post-hospital discharge

Secondary Outcomes

Description: Care treatment such as ventilator use, intubation, and/or tracheostomy

Measure: Limitations of patient care- Frequency of care not being provided

Time: During In-hospital course, up to 1 month

Measure: Limitations of patient care- Conversion of DNR/DNI/CMO status

Time: During In-hospital course, up to 1 month
21 Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.

NCT04510038
Conditions
  1. Covid19
  2. Myocardial Injury
Interventions
  1. Drug: Colchicine
  2. Other: Covid-19 Standard of Care
MeSH:Wounds and Injuries

Primary Outcomes

Description: Composite of all-cause mortality

Measure: All Cause Mortality

Time: 90 days

Description: Need for Mechanical Ventilation

Measure: Mechanical Ventilation

Time: 90 days

Description: Need for Mechanical Circulatory Support

Measure: Mechanical Circulatory Support

Time: 90 days

Secondary Outcomes

Description: Time to Primary Endpoint

Measure: Time to Deterioration

Time: 90 days

Description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".

Measure: Adverse Events

Time: 90 days

Description: Peak Troponin Levels

Measure: Troponin

Time: 90 days

Description: Troponin Levels Change from Baseline

Measure: Delta

Time: 90 days

Description: Change from Baseline on BNP levels

Measure: BNP

Time: 90 days

Description: Changes from Baseline on C Reactive Protein

Measure: Changes in C Reactive Protein

Time: 90 days

Description: Hospital Length of Stay

Measure: LOS

Time: 90 days

Description: Re-Hospitalization Rates

Measure: Re-Hospitalization

Time: 90 days

Description: Changes in D Dimer from Baseline

Measure: Changes in D Dimer

Time: 90 days
22 Can Nebulised HepArin Reduce acuTE Lung Injury in Patients With SARS-CoV-2 Requiring Mechanical Ventilation in Ireland

Existing information suggests that a drug called heparin, given through a device called a nebuliser, will decrease severity of lung damage caused by COVID-19 who require the assistance of a ventilator to breathe. It is thought that heparin could do this through multiple mechanisms. The investigators will measure the effect with a marker called d-dimer, which is related to blood clotting, and monitor the safety of this treatment as one of the major outcomes for the study. The investigators will also assess clinical outcomes such as markers of oxygen levels, time to liberation from a ventilator in patients with COVID-19 lung disease, and functional outcomes at day 28 and 60 as secondary outcomes.

NCT04511923
Conditions
  1. Covid19
  2. ARDS, Human
  3. Lung Injury, Acute
  4. Ventilation Perfusion Mismatch
Interventions
  1. Drug: Nebulised heparin
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Description: Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.

Measure: D-dimer profile

Time: Up to day 10.

Description: Safety of nebulised heparin delivered by aerogen solo nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.

Measure: Frequenccy of Severe Adverse Outcomes

Time: Up to day 60

Secondary Outcomes

Description: Determine the impact of nebulised heparin on oxygenation index

Measure: Oxygenation Index

Time: Up to day 10

Description: Effect of nebulised heparin on indices of inflammation (Interleukin (IL)-1β, IL-6, IL-8, IL-10 and soluble TNF receptor 1 (sTNFR1), C-reactive protein, procalcitonin, Ferritin,) will be assessed (AUC on days 1, 3, 5 and 10)

Measure: Indices of Inflammation

Time: Up to day 10

Description: Effect of nebulised heparin on the ratios of IL-1β/IL-10 and IL-6/IL-10 will also be assessed.

Measure: Ratios of Indices of Inflammation

Time: Up to day 10

Description: Effect of nebulised heparin on other indices of coagulation (Fibrinogen; lactate dehydrogenase) will be assessed (AUC on days 1, 3, 5 and 10).

Measure: Indices of Coagulation

Time: Up to day 10

Description: Determine the effect of nebulised heparin on Quasi-Static Lung Compliance (i.e. tidal volume/(Plateau pressure-PEEP) measured on days 1,3,5,10.

Measure: Quasi-Static Lung Compliance

Time: Up to day 10

Description: Time to separation from invasive ventilation, where non survivors are treated as though not separated from invasive ventilation.

Measure: Time to separation from invasive ventilation

Time: Up to day 28

Description: Number treated with neuromuscular blockers instituted after enrolment

Measure: Number treated with neuromuscular blockers

Time: Up to day 10

Description: Number treated with prone positioning instituted after enrolment

Measure: Number treated with Prone positioning

Time: Up to day 10

Description: Number treated with extra-corporeal membrane oxygenation instituted after enrolment

Measure: Number treated with extra-corporeal membrane oxygenation

Time: Up to day 10

Description: Number tracheotomised

Measure: Number requiring Tracheostomy

Time: Up to day 28

Description: Time to separation from invasive ventilation among survivors

Measure: Time to separation from invasive ventilation among survivors

Time: Up to day 28

Description: Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from invasive care

Measure: Discharge to ward

Time: Up to day 28

Description: Time to discharge from the ICU to day 28, among survivors

Measure: Discharge to ward in survivors

Time: Up to day 28

Description: Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60

Measure: Patient Survival

Time: Up to day 60

Description: Number residing at home or in a community setting at day 60

Measure: Number of patients residing at home or in a community setting at day 60

Time: Up to day 60

Description: Number residing at home or in a community setting at day 60, among survivors

Measure: Number of surviving patients residing at home or in a community

Time: Up to day 60
23 A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection

The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.

NCT04526912
Conditions
  1. Acute Lung Injury
Interventions
  1. Drug: VIB7734
  2. Drug: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Description: Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors)

Measure: The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness

Time: Day 1 (Baseline) through Day 28

Secondary Outcomes

Description: Defined as measure of safety

Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events

Time: Day 1 (Baseline) through Day 70

Description: Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time [PT], partial thromboplastin time [PTT], D dimer, fibrinogen), and urinalysis)

Measure: Change in safety laboratory parameters

Time: Day 1 (Baseline) through Day 70
24 Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization

Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or at risk for development of acute kidney injury (AKI). The objective of this study is to determine the role of a protocol to manage urine alkalization using a simple medication that has been used for a very long time, is safe, and without significant side-effects. We aim to determine the feasibility and safety of a urine alkalinization protocol for the prevention of AKI in patients testing positive for COVID-19.

NCT04530448
Conditions
  1. COVID
  2. Coronavirus
  3. Coronavirus Infection
  4. AKI
  5. Acute Kidney Injury
Interventions
  1. Drug: Sodium bicarbonate
  2. Other: Standard of Care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Primary feasibility outcome will be the proportion of patients treated who achieve >50% of urine measurements pH ≥= 7.2 over the duration of treatment.

Measure: pH

Time: 10 days

Description: Primary efficacy outcome will be the number of days alive and free of stage 2-3 AKI (up to 28) in each group.

Measure: Number of Days Alive Free of Stage 2-3 AKI

Time: 28 days post-treatment

Secondary Outcomes

Description: proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment).

Measure: Stage 2-3 AKI

Time: 28 days

Description: Ventilator-free days to 28 days

Measure: Vent-Free

Time: 28 days

Description: Hospital-free days to 60 days

Measure: Hospital-Free

Time: 60 days post-index hospitalization
25 A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, PK, & PD of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure

The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure. Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part. The name of the study drug involved in this study is: RLS-0071.

NCT04574869
Conditions
  1. Acute Lung Injury
  2. ALI
  3. COVID-19
Interventions
  1. Drug: RLS-0071
  2. Drug: RLS-0071
  3. Drug: Placebo
  4. Drug: RLS-0071
  5. Drug: RLS-0071
  6. Drug: Placebo
MeSH:Pneumonia Respiratory Insufficiency Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries
HPO:Pneumonia

Primary Outcomes

Measure: Frequency and severity of Adverse Events, including Serious Adverse Events, by treatment group and dose level, including the frequency of premature discontinuation of study intervention due to Adverse Events.

Time: Through study completion at Day 28 following last dose.

Secondary Outcomes

Measure: Incidence of clinically significant changes from baseline in clinical laboratory values, ADA, autoantibody panel, vital signs, physical examination, ECG, radiography, and concomitant medications.

Time: Through study completion at Day 28 following last dose; (if positive ADA/antibodies, Day 90 and Day 180 following last dose).

Measure: Number of patients with positive ADA titers after receiving a single dose (Part A) or multiple doses (Part B) of RLS-0071.

Time: Through study completion at Day 28 following last dose; (if positive ADA/antibodies, Day 90 and Day 180 following last dose).

Measure: Estimates of single-dose maximum plasma concentration (Cmax) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of single-dose time to maximum plasma concentration (Tmax) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of single-dose minimum plasma concentration (Cmin) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of single-dose area under the plasma concentration-time curve (AUC) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of single-dose apparent total volume of distribution for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of single-dose apparent total body clearance for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of single-dose apparent first-order terminal elimination half-life for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing), 5 and 30 minutes after start of dosing, and 1, 2, 3, 4, 5, 6, 7, 8,12, 18, 24, 36, and 48 hours after the start of dosing, up to 28 days following last dose.

Measure: Estimates of multiple-dose maximum plasma concentration (Cmax) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose peak time to maximum plasma concentration (Tmax) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose area under the plasma concentration-time curve (AUC) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose average plasma drug concentration observed (Cavg) for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose trough concentration prior to dose administration (Ctrough).

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose apparent total volume of distribution for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose apparent total body clearance for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Estimates of multiple-dose apparent first-order terminal elimination half-life for RLS-0071.

Time: Pre-Dose (within 30 minutes before start of dosing); 30 minutes after the start of dosing; and 1, 2, 4, 6, 12, 18, 24, 36, and 48 hours after the start of dosing. The last PK sample will be taken 48 hours following the last dosing (the 9th infusion).

Measure: Assessment of dose response relationship of single and multiple doses of RLS-0071 on C1q levels and the complement activity assay.

Time: Through study completion at Day 28 following last dose.

Measure: Overall survival.

Time: Through Day 15 and through study completion at Day 28 following last dose.

Measure: Incidence of progression to respiratory failure requiring mechanical ventilation.

Time: Days on ventilation while in the hospital through study completion at Day 28.

Measure: Incidence of transfer to the ICU.

Time: Through Day 15 following last dose; through study completion at Day 28 following last dose; and duration of ICU stay days in the hospital post-dose through study completion at Day 28.

Measure: Duration of hospitalization after treatment (days).

Time: Through study completion at Day 28 following last dose.

Measure: Incidence, severity, and duration after treatment (days) of fever (≥ 39.0°C).

Time: Through study completion at Day 28 following last dose.

Measure: Incidence, severity, and duration after treatment (days) of cough per investigator assessment of CTCAE's latest version.

Time: Through study completion at Day 28 following last dose.

Measure: Duration of requirement for supplemental oxygen after treatment (days).

Time: Through study completion at Day 28 following last dose.

Measure: PaO2/FiO2

Time: Through study completion at Day 28 following last dose.

Measure: Incidence, severity, and duration after treatment (days) of new cardiovascular events as assessed by the investigator (e.g. myocardial infarction, stroke, TIA, ischemic limb) with CTCAE's latest version.

Time: Through Day 15 and through study completion at Day 28 following last dose.

Measure: Incidence, severity, and duration after treatment (days) of respiratory acidosis as assessed by the investigator with CTCAE's latest version.

Time: Through Day 15 and through study completion at Day 28 following last dose.

Description: Dialysis will be assessed by the investigator with CTCAE's latest version.

Measure: Incidence and duration after treatment (days) of dialysis.

Time: Through Day 15 and through study completion at Day 28 following last dose.

Measure: Levels of complement activity (eg, CH50).

Time: Through study completion at Day 28 following last dose.

Measure: Levels of C1q (free and bound to RLS-0071).

Time: Through study completion at Day 28 following last dose.
26 Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19)

This is a prospective observational parallel group cohort study that will aim to recruit 220 participants who were admitted to the hospital with COVID-19 between 1st March 2020 and 30th June 2020 (Group A - 110 participants who had COVID-19 with AKI; Group B - 110 participants who had COVID-19 without AKI). Data from groups A and B will be compared with AKI and non-AKI groups from an existing study database (ARID study, n=1125) who were recruited before the outbreak of the COVID-19 pandemic (recruitment 2013-2016) and who have all completed at least three years of follow up. Participants who have recovered from COVID-19 will be matched for analysis to participants from the ARID study for AKI status, baseline estimated glomerular filtration rate (eGFR) stage, age (± 5 years) and presence of diabetes. Potential participants will receive a letter of invitation along with a comprehensive participant information sheet (PIS).

NCT04583293
Conditions
  1. Acute Kidney Injury
Interventions
  1. Other: No intervention
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30%

Measure: Incidence of kidney disease progression at 12 months.

Time: 12 months after hospital discharge.

Secondary Outcomes

Description: Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.

Measure: Incidence of albuminuria at 6-9 months.

Time: 6-9 months after hospital discharge.

Description: Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.

Measure: Incidence of albuminuria at 12-15 months.

Time: 12-15 months after hospital discharge.

Description: Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).

Measure: Incidence of combined kidney disease progression and albuminuria at 6-9 months.

Time: 6-9 months after hospital discharge.

Description: Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).

Measure: Incidence of combined kidney disease progression and albuminuria at 12-15 months.

Time: 12-15 months after hospital discharge.

Description: Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality

Measure: Factors associated with all-cause mortality at 6-9 months.

Time: 6-9 months after hospital discharge.

Description: Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality

Measure: Factors associated with all-cause mortality at 12-15 months.

Time: 12-15 months after hospital discharge.

Description: Number of hospital readmissions

Measure: Incidence of hospital readmissions at 6-9 months

Time: 6-9 months after hospital discharge.

Description: Number of hospital readmissions

Measure: Incidence of hospital readmissions at 12-15 months

Time: 12-15 months after hospital discharge.
27 Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19) as Determined by Multiparametric Magnetic Resonance Imaging (MRI)

This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).

NCT04594291
Conditions
  1. Acute Kidney Injury
Interventions
  1. Procedure: MRI scans
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Global organ structure will be assessed through structural T1- and T2-weighted MRI scans which will provide information about automated segmentation and volume assessment of whole kidney (and both cortex and medulla) as well as other abdominal organs (including liver and spleen). Global organ structure will also be assessed through longitudinal (T1) and transverse (T2) relaxation time mapping. T1 and T2 increase with tissue inflammation, oedema and fibrosis. A respiratory-triggered inversion recovery (IR) spin-echo echo-planar scheme will be used for abdominal T1 mapping and a Gradient and spin echo (T2-GraSE) scheme for abdominal T2 mapping.

Measure: MRI assessment of global organ structure at 12 months.

Time: 12 months

Description: R2* data will be acquired using a multi-echo fast field echo (mFFE) scheme to assess thrombi. Conventionally R2* mapping is used as a measure of oxygenation, but R2*is likely to be altered by other factors in COVID-19, including oedema and small vessel thrombotic processes.

Measure: MRI assessment of thrombi (R2*) at 12 months.

Time: 12 months

Description: Mean transit time and perfusion depicting changes in microvascular blood flow and large vessel flow/thrombosis will be determined using a FAIR labelling scheme with a multi-slice spin-echo echo-planar imaging readout and multiple labelling delay times.

Measure: MRI assessment of organ perfusion (Arterial spin labelling [ASL]) at 12 months.

Time: 12 months

Secondary Outcomes

Description: Global organ structure will be assessed through structural T1- and T2-weighted MRI scans which will provide information about automated segmentation and volume assessment of whole kidney (and both cortex and medulla) as well as other abdominal organs (including liver and spleen). Global organ structure will also be assessed through longitudinal (T1) and transverse (T2) relaxation time mapping. T1 and T2 increase with tissue inflammation, oedema and fibrosis. A respiratory-triggered inversion recovery (IR) spin-echo echo-planar scheme will be used for abdominal T1 mapping and a Gradient and spin echo (T2-GraSE) scheme for abdominal T2 mapping.

Measure: MRI assessment of global organ structure.

Time: 3-6 and 24 months

Description: R2* data will be acquired using a multi-echo fast field echo (mFFE) scheme to assess thrombi. Conventionally R2* mapping is used as a measure of oxygenation, but R2*is likely to be altered by other factors in COVID-19, including oedema and small vessel thrombotic processes.

Measure: MRI assessment of thrombi (R2*).

Time: 3-6 and 24 months

Description: Mean transit time and perfusion depicting changes in microvascular blood flow and large vessel flow/thrombosis will be determined using a FAIR labelling scheme with a multi-slice spin-echo echo-planar imaging readout and multiple labelling delay times.

Measure: MRI assessment of organ perfusion (ASL)

Time: 3-6 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with estimated glomerular filtration rate (ml/min/1.73m2).

Measure: Correlations between MRI measures with estimated glomerular filtration rate.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with urine albumin creatinine ratio (mg/mmol) and urine protein creatinine ratio (mg/mmol).

Measure: Correlations between MRI measures with urine albumin and protein creatinine ratios.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the mental component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life mental domain.

Measure: Correlations between MRI measures with mental component score.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the physical component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life physical domain.

Measure: Correlations between MRI measures with physical component score.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the health state score calculated from the European Quality of Life 5-Dimensions questionnaire. The health state score ranges from -0.285 (for the worst health state) to 1 (for the best health state).

Measure: Correlations between MRI measures with health state score.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the visual analogue score from the European Quality of Life 5-Dimensions questionnaire. The visual analogue score uses a thermometer-like scale numbered from 0 to 100; the higher the score, the better the health state.

Measure: Correlations between MRI measures with visual analogue score.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the fatigue score from the Fatigue Severity Scale, a 9-item questionnaire scored on a 7-point scale (minimum score=9; maximum score=63); the higher the score, the greater the fatigue severity.

Measure: Correlations between MRI measures with fatigue severity.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with the fatigue score from the Visual Analogue Fatigue Scale, which uses an horizontal line scale numbered from 0 to 10; the higher the score, the higher the fatigue.

Measure: Correlations between MRI measures with fatigue score.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with skin autofluorescence levels (arbitrary units) measured with the validated Autofluorescence Reader Standard Unit (SU) version 2.4.3 (AGE Reader SU, DiagnOptics Technologies BV, Aarhusweg 4-9, Groningen, The Netherlands).

Measure: Correlations with MRI measures with skin autofluorescence levels.

Time: 3-6, 12 and 24 months

Description: Mean change in mental component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life mental domain.

Measure: Mean change in mental component score.

Time: 3-6, 12 and 24 months

Description: Mean change in physical component score. A score between 0 and 100 is calculated from the 36-Item Short-Form Health Survey; the higher the score, the better the quality of life physical domain.

Measure: Mean change in physical component score.

Time: 3-6, 12 and 24 months

Description: Mean change in health state score calculated from the European Quality of Life 5-Dimensions questionnaire. The health state score ranges from -0.285 (for the worst health state) to 1 (for the best health state).

Measure: Mean change in health state score.

Time: 3-6, 12 and 24 months

Description: Mean change in visual analogue score from the European Quality of Life 5-Dimensions questionnaire. The visual analogue score uses a thermometer-like scale numbered from 0 to 100; the higher the score, the better the health state.

Measure: Mean change in visual analogue score.

Time: 3-6, 12 and 24 months

Description: Mean change in fatigue score as assessed by the Fatigue Severity Scale, a 9-item questionnaire scored on a 7-point scale (minimum score=9; maximum score=63); the higher the score, the greater the fatigue severity.

Measure: Mean change in fatigue severity scale.

Time: 3-6, 12 and 24 months

Description: Mean change in fatigue score as assessed by the Visual Analogue Fatigue Scale, which uses an horizontal line scale numbered from 0 to 10; the higher the score, the higher the fatigue.

Measure: Mean change in fatigue score.

Time: 3-6, 12 and 24 months

Description: Mean change in skin autofluorescence levels (arbitrary units) measured with the AGE Reader.

Measure: Mean change in skin autofluorescence levels.

Time: 3-6, 12 and 24 months

Description: Assessment of kidney disease progression defined as decrease in estimated glomerular filtration rate (eGFR) of ≥25% associated with a decline in eGFR stage.

Measure: Incidence of kidney disease progression.

Time: 3-6, 12 and 24 months

Description: Recording of the number of participants who developed any cardiovascular events.

Measure: Incidence of cardiovascular events.

Time: 3-6, 12 and 24 months

Description: Correlations between MRI measures (Cortical T1, ASL-perfusion, T2, R2*) with all-cause mortality using multi-variable Cox proportional hazards models.

Measure: Correlations between MRI measures with all-cause mortality.

Time: 12 and 24 months
28 Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19 Randomized Controlled Trial

With the results of this study the investigators aim to identify an effective treatment that will reduce morbidity and mortality of patients with symptomatic COVID-19 infection, which would in turn reduce the burden on the healthcare system by decreasing the need for intensive care. Objectives: The main objective of this research is to determine if once weekly treatment with the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiac complications of COVID-19 infection. Study Plan: The study design is prospective randomized open-label blinded-evaluation (PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced risk profile as described above, who have been admitted to hospital due to symptoms of COVID-19 infection but do not as yet require critical care will be approached to participate in this study. Provided there are no exclusion criteria and the participants agree by means of documented written informed consent, The participants the participantswill be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately after randomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn at Day 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG will be obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28. Primary outcome measure: A composite of (1) death from any cause or (2) mechanical ventilation (invasive or non-invasive) at 28 days. Major secondary outcome measure: (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at Day 7±2 days and Day 14±2 days post randomization. Other major secondary outcome measure: A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.

NCT04615871
Conditions
  1. Covid19
  2. Myocardial Injury
Interventions
  1. Drug: semaglutide
MeSH:Wounds and Injuries

Primary Outcomes

Description: All cause death or invasive or non-invasive mechanical ventilation

Measure: Composite of death or mechanical ventilation

Time: 28 days after randomization

Secondary Outcomes

Description: (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days) post randomization.

Measure: cardiac troponin level

Time: 7±2 days after randomization

Description: (1) an elevation to >99th percentile URL upper reference limit (URL) in those with a baseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline in those with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days) post randomization.

Measure: cardiac troponin level

Time: 14±2 days after randomization

Description: The ECG will be evaluated for deviation from normal or from baseline (QRS, ST-T wave changes

Measure: ECG

Time: Day 7±2 and Day 14±2

Description: The number of days that a patient is alive and free of organ support through 28 days after trial entry. Organ support is defined by receipt for non-invasive mechanical ventilation, high flow nasal cannula oxygen, mechanical ventilation, or vasopressor therapy. Non-invasive mechanical ventilation is defined as bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) when used for acute respiratory support (Use of BIPAP or CPAP at night or when sleeping for sleep apnea is not considered organ support) High Flow Nasal Cannula Oxygen: defined as receiving ≥30 l/min flow at FiO2 ≥40% Invasive mechanical ventilation is defined as positive pressure ventilation through endotracheal tube or tracheostomy Vasopressor support includes infusion of any vasoactive or inotropic medication

Measure: 28-day organ support-free days

Time: 28 days

Description: Intensification of medical therapy includes the need for ECLS, mechanical ventilation (invasive or non-invasive [BIPAP]) and/or vasopressor/inotropic therapy on Day 180 post randomization.

Measure: A composite of death or intensification of medical therapy

Time: 180 days
29 Effect of Liver Injury on Mortality in Coronavirus Disease-2019 Patients Admitted to Intensive Care Unit

In addition to primarily affecting the lungs, coronavirus disease-2019 (COVID-19) disease can also affect many different organs, especially the heart, kidneys, liver and brain. In this group of patients, the impact of an important organ such as the liver can lead to a further deterioration of the clinical course. In this study, critical patients admitted to Gazi Yasargil Training and Research Hospital intensive care unit (ICU) due to COVID-19 between April 1 and October 1, 2020 were retrospectively analyzed. The effect of liver damage on mortality in critical COVID-19 patients was investigated. The necessary permits for the study were obtained from the Scientific Research Platform of the T.R. Ministry of Health. (20.11.2020) Patients diagnosed with COVID-19 on the specified dates, followed in the ICU, older than 18 years, identified as critical/serious according to the World Health Organization and provisional guidelines of the Scientific Board of the T.R. Ministry of Health will be included in the study. ICU patients without COVID-19, COVID-19 patients under 18 years of age,COVID-19 patients with known liver disease, and COVID-19 patients with mild to moderate symptoms will be excluded from the study. Patients' age, gender, comorbidity, Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) scores when first admitted to the ICU, hemogram parameters (white blood cell count, neutrophil, lymphocyte, hemoglobin, platelet count), coagulation parameters (prothrombin time, activated partial thromboplastin time and D-dimer, blood biochemistry results (C-reactive protein, lactate dehydrogenase, creatine kinase , alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin and indirect bilirubin), procalcitonin and ferritin levels will be recorded. In addition, the number of days spent in the ICU and whether mortality develops or not will be recorded. It will also be recorded whether mortality develops on day 7 and day 28. Patients will be divided into three groups according to their ALT, AST and total bilirubin levels at the time of admission to the ICU. Group 1 will consist of patients with normal ALT, AST and total bilirubin values. Group 2 will consist of patients whose ALT, AST or total bilirubin levels are up to 3 times upper limit of normal. Group 3 will consist of patients whose ALT, AST or total bilirubin levels are increased more than 3 times upper limit of normal.

NCT04669509
Conditions
  1. Covid19; Liver Injury; Mortality
Interventions
  1. Diagnostic Test: Liver function tests
MeSH:Wounds and Injuries

Primary Outcomes

Description: Effect of Liver Injury on Mortality

Measure: 7 and 28 day mortality

Time: Patients hospitalized in the ICU within 6 months
30 The STEP Program: Building Trauma Resilience Among Nurses and Personal Support Workers at Providence Healthcare During and Beyond the COVID-19 Pandemic

The COVID-19 pandemic has amplified the need for skills training and mental health support for healthcare workers who are exposed to the numerous stressors and potential trauma of a high-risk environment. This context is associated with significant impacts on mental health, including depression, anxiety, and post-traumatic stress, with nurses and personal support workers (PSWs) being disproportionately impacted. The proposed STEP program is an intervention that aims to equip nurses and PSWs with the skills and support needed to promote their wellness and navigate the challenges of experiencing trauma in a high-risk, high-stress environment, which has been exacerbated by the pandemic. As such, the STEP intervention has the potential to improve trauma resilience and mental health among nurses and PSW, which may ultimately improve patient care and benefit the hospital system during and even beyond the pandemic. The results from this study will also provide vital insight into promising interventions for healthcare workers that are accessible and scalable.

NCT04682561
Conditions
  1. Stress
  2. Trauma
  3. Mental Health Issue
  4. Healthcare Workers
Interventions
  1. Behavioral: Supportive Trauma Exposure Preparation Program
MeSH:Wounds and Injuries

Primary Outcomes

Description: The ProQOL is a 30-item self-report questionnaire assessing negative and positive effects of helping others who experience suffering and trauma, with subscales for compassion satisfaction, burnout and compassion fatigue. Focus will be paid to the burnout subscale score.

Measure: Changes from baseline to post-intervention (8 weeks) in healthcare worker burnout using Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) burnout subscale

Time: Baseline, week 4, week 8 and 3 months

Secondary Outcomes

Description: The CD-RISC 10 is a 10-item self-report scale used to measure ability to cope with stress and adversity as an indicator of resilience.

Measure: Changes in healthcare worker resilience using Connor-Davidson Resilience Scale 10 item (CD-RISC 10)

Time: Baseline, week 8, and 3 months

Description: The PHQ-9 is a 9-item self-report scale assessing depression symptoms.Total scores range from 0 to 27, with higher scores reflecting more severe anxiety. Focus will be paid to changes in depression symptom severity.

Measure: Changes in healthcare worker depression symptoms using Patient Health Questionnaire - 9 item (PHQ-9)

Time: Baseline, weeks 2-8, and 3 months

Description: The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety. Focus will be paid to changes in anxiety severity.

Measure: Changes in healthcare worker anxiety symptoms using Generalized Anxiety Disorder 7-item scale (GAD-7)

Time: Baseline, weeks 2-8, and 3 months

Description: The ProQOL is a 30-item self-report questionnaire assessing negative and positive effects of helping others who experience suffering and trauma, with subscales for compassion satisfaction, burnout and compassion fatigue.

Measure: Changes in healthcare worker compassion satisfaction and secondary traumatic stress subscales of the Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL)

Time: Baseline, week 4, week 8 and 3 months

Description: This will be assessed by asking participants to rate their perception of the quality of patient care they provided on their last shift, using a 4-point Likert scale.

Measure: Changes in healthcare worker perceived quality of patient care

Time: Baseline, weeks 2-8, and 3 months

Description: The SDS is a brief 3-item self-report scale that probes work/school, social, and family/home functioning. Each item is scored from 0 to 10. Total scores range from 0 (unimpaired) to 30 (highly impaired).

Measure: Changes in Sheehan Disability Scale (SDS) score

Time: Baseline, week 4, week 8, and 3 months

Description: The LEAPS is a 10-item, self-rated scale that provides a measure of functioning at work.

Measure: Changes in The Lam Employment Absence and Productivity Scale (LEAPS) score

Time: Baseline, week 2, week 4, week 6, week 8 and 3 months

Other Outcomes

Description: Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the STEP Program

Measure: Participant feedback on their experiences with specific aspects of the STEP program

Time: 3 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

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Alphabetical index of all Terms

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