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Sections: Correlations,
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Navigate: Clinical Trials and HPO
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 | |
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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 |
Name (Synonyms) | Correlation | |
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D058186 | Acute Kidney Injury NIH | 0.39 |
D000070642 | Brain Injuries, Traumatic NIH | 0.26 |
D001930 | Brain Injuries, NIH | 0.24 |
Name (Synonyms) | Correlation | |
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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 |
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 |
Navigate: Correlations HPO
There are 30 clinical trials
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.
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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsThe 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.
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 daysDescription: 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 daysDescription: 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 daysThe 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.
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 monthsDescription: 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 monthsThe 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.
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 daysDescription: days
Measure: Time to reach an afebrile state for 48 hours. Time: 56 daysDescription: days
Measure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300 Time: 56 daysDescription: days
Measure: Time to reach FR ≤ 24 rpm for 48 hours Time: 56 daysDescription: days
Measure: Time to normalization of D-dimer (<250 ug / L) Time: 56 daysDescription: days
Measure: Time until PCR normalization (<5mg / L). Time: 56 daysDescription: days
Measure: Time until normalization of ferritin (<400ug / L) Time: 56 daysDescription: viral load
Measure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR Time: 56 daysDescription: days
Measure: Time until hospital discharge Time: 56 daysDescription: days
Measure: Need for ventilatory support devices Time: 56 daysDescription: days
Measure: Duration that it is necessary to maintain ventilatory support. Time: 56 daysDescription: days
Measure: COVID-19 mortality Time: 56 daysDescription: days
Measure: all-cause mortality Time: 56 daysDescription: 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 daysDescription: 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 daysThis 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.
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 daysDescription: Change in serum oxalate levels
Measure: Renal safety biomarkers - serum oxalate Time: On days 5,7 and 14Description: Microscopic analysis of urine for presence of oxalate stones
Measure: Renal safety biomarkers - urine oxalate stones Time: On days 5,7 and 14Description: 24-hour urine oxalate levels
Measure: Renal safety biomarkers - 24-hour urine oxalate levels Time: On days 5,7 and 14Description: Renal-failure free days, with AKI defined by the KDIGO criteria
Measure: Acute Kidney Injury-free days Time: On day 28, 90Description: Mortality by all causes
Measure: Number of deaths Time: On day 28, 60 and 90 daysDescription: Difference in plasma ferritin levels in ng/mL, compared to baseline levels
Measure: Change in plasma ferritin levels Time: Days 1-7 compared with baselineDescription: 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 baselineDescription: 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 baselineDescription: 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 baselineDescription: 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-daysDescription: Percentage of patients alive and not requiring invasive mechanical ventilation
Measure: Proportion of patients alive and free of invasive mechanical ventilation Time: At 28-daysCoronavirus 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,
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 monthsDescription: Factors associated with worse outcome
Measure: Prognostic factors associated with death Time: through study completion, an average of 6 monthsDescription: Description of patients hospitalized with COVID-19
Measure: Clinical characteristics of patients who developed liver injury Time: through study completion, an average of 6 monthsThe 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.
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 monthsDescription: viral RNA concentration in urine, ME/ml
Measure: The expression of viral RNA in the urine with the severity of renal failure Time: 2 monthsDescription: albumine excretion with urine, g/ml
Measure: The severity of microalbuminuria in patients with COVID-19 of different conditions and renal failure Time: 2 monthsDescription: estimated glomerular filtration rate (eGFR), ml/min
Measure: Assessment of the severity of renal impairment in patients who died from COVID-19 Time: 2 monthsDescription: 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 monthsDescription: 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 monthsRandomized, 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
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.
Description: Number of death during hospitalization
Measure: Number of In-Hospital Death Time: During hospitalization, average 2-3 weeksDescription: Length of stay in the hospital
Measure: Length of Stay Time: During hospitalization, average 2-3 weeksDescription: Successful treatment will be defined by two consecutive negative tests for COVID-19
Measure: Number of Successful Treatment Time: During hospitalization, average 2-3 weeksTo 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.
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 daysDescription: 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 daysDescription: Oxygen therapy provided as non-invasive therapy for ARDS patients.
Measure: Time on nasal cannula or oxygen masks Time: 28 daysDescription: 28 day mortality - all cause and attributable
Measure: 28 day mortality - all cause and attributable Time: 28 daysDescription: ICU and hospitalization length of stay (days)
Measure: ICU and hospitalization length of stay (days) Time: 28 daysDescription: 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 daysDescription: 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 daysDescription: Vasopressor free days
Measure: Vasopressor free days Time: 28 daysDescription: 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 daysDescription: 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 daysDescription: Incidence of other organ (non-lung) disorders
Measure: Incidence of non-lung disorders Time: 28 daysDescription: Change in liver function tests (ALT, AST, and total bilirubin levels) from baseline
Measure: Measures of liver dysfunction Time: 28 daysDescription: Change in SCr and eGFR from baseline
Measure: Measures of kidney dysfunction Time: 28 daysDescription: Change in highly-sensitive troponin (hs-troponin) from baseline
Measure: Measures of cardiac dysfunction Time: 28 daysDescription: Change from baseline ACT, aPTT, and/or PT/INR levels
Measure: Measures of coagulopathies Time: 28 daysDescription: Change in baseline antiviral immunoglobulins (IgG, IgM) at EOS.
Measure: Changes in immunogenic responses Time: 28 daysDescription: Changes in total healthcare costs from admission to discharge between treatment groups.
Measure: Healthcare outcomes Time: 28 daysDescription: 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 daysDescription: Pharmacokinetics of LSALT peptide over the study period.
Measure: Pharmacokinetics of LSALT peptide Time: 28 daysThe 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.
Description: Occurence of moderate or severe AKI
Measure: Occurence of acute kidney injury (AKI) Time: within 7 days after beginning of moderate or severe ARDSDescription: 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 ARDSThe 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.
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 28Description: 1-month mortality
Measure: Proportion of subjects who are alive Time: Baseline to Day 28Persons 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.
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 monthDescription: 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 monthDocument 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.
Description: Fear of COVID-19 Questionnaire
Measure: Change in Fear of COVID-19 Time: baseline, 3 months, 6 monthsDescription: 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 monthsDescription: NeuroQol SF v1.0 - Depression
Measure: Change in depressive symptoms Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Pos. Affect & Well-Being
Measure: Change in positive affect and well-being Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Anxiety
Measure: Change in anxiety Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Fatigue
Measure: Change in fatigue Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol
Measure: Change in emotional and behavioural dyscontrol Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Satisfaction w SRA
Measure: Change in satisfaction with social roles and activities Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Sleep Disturbance
Measure: Change in sleep disturbance Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Stigma
Measure: Change in stigma Time: baseline, 3 months, 6 monthsDescription: NeuroQol SF v1.0 - Cognitive Function
Measure: Change in cognitive function Time: baseline, 3 months, 6 monthsDescription: 23 questions about strategies to social distance
Measure: Change in social distancing strategies used Time: baseline, 3 months, 6 monthsDescription: 22 questions about social distancing
Measure: Change in thoughts and feelings about social distancing Time: baseline, 3 months, 6 monthsThe 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.
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.
Description: As defined by Kidney Diseases: Improving Global Outcomes (KDIGO) criteria
Measure: Incidence of any stage of acute kidney injury Time: 14 daysDescription: Mortality
Measure: Mortality Time: 14-day, hospital, and intensive care unit (ICU) mortalityDescription: Defined by return of creatinine to < 1.5 times of baseline
Measure: Renal recovery Time: 14 daysDescription: Percentage
Measure: Percentage of patients who receive renal replacement therapy Time: 14 daysDescription: Percentage of participants who are dialysis dependent
Measure: Percentage of participants who are dialysis dependent Time: Through study completion, an average of 90 daysDescription: Days without vasoactive medications and mechanical ventilation
Measure: Free-days of vasoactive medications and mechanical ventilation Time: Day 30Description: 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 daysDescription: 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 daysDescription: 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 daysThe 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
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 monthsThis 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.
Description: Kidney Disease Improving Global Outcomes (KDIGO) Staged AKI by serum creatinine or urine output
Measure: Acute Kidney Injury (AKI) Time: 14 daysDescription: Survival to ICU discharge or Day 14
Measure: Survival Time: 14 daysDescription: The use of extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy
Measure: Rate of Extracorporeal Therapy Requirement Time: 14 daysDescription: >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 EnrollmentDescription: The exposure of enrolled patients to known nephrotoxic medications, including diuretics
Measure: Rate of nephrotoxic medication exposure Time: Day of EnrollmentCOVID-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.
Description: within the study period, trauma patients who admitted to any of the seven study centers will be recorded.
Measure: trauma admissions Time: 3 monthsA prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.
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 monthOpen-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.
Description: Composite of all-cause mortality
Measure: All Cause Mortality Time: 90 daysDescription: Need for Mechanical Ventilation
Measure: Mechanical Ventilation Time: 90 daysDescription: Need for Mechanical Circulatory Support
Measure: Mechanical Circulatory Support Time: 90 daysDescription: Time to Primary Endpoint
Measure: Time to Deterioration Time: 90 daysDescription: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Measure: Adverse Events Time: 90 daysDescription: Peak Troponin Levels
Measure: Troponin Time: 90 daysDescription: Troponin Levels Change from Baseline
Measure: Delta Time: 90 daysDescription: Change from Baseline on BNP levels
Measure: BNP Time: 90 daysDescription: Changes from Baseline on C Reactive Protein
Measure: Changes in C Reactive Protein Time: 90 daysDescription: Hospital Length of Stay
Measure: LOS Time: 90 daysDescription: Re-Hospitalization Rates
Measure: Re-Hospitalization Time: 90 daysDescription: Changes in D Dimer from Baseline
Measure: Changes in D Dimer Time: 90 daysExisting 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.
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 60Description: Determine the impact of nebulised heparin on oxygenation index
Measure: Oxygenation Index Time: Up to day 10Description: 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 10Description: 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 10Description: 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 10Description: 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 10Description: 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 28Description: Number treated with neuromuscular blockers instituted after enrolment
Measure: Number treated with neuromuscular blockers Time: Up to day 10Description: Number treated with prone positioning instituted after enrolment
Measure: Number treated with Prone positioning Time: Up to day 10Description: Number treated with extra-corporeal membrane oxygenation instituted after enrolment
Measure: Number treated with extra-corporeal membrane oxygenation Time: Up to day 10Description: Number tracheotomised
Measure: Number requiring Tracheostomy Time: Up to day 28Description: Time to separation from invasive ventilation among survivors
Measure: Time to separation from invasive ventilation among survivors Time: Up to day 28Description: 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 28Description: Time to discharge from the ICU to day 28, among survivors
Measure: Discharge to ward in survivors Time: Up to day 28Description: Survival to day 28; Survival to day 60; and Survival to hospital discharge, censored at day 60
Measure: Patient Survival Time: Up to day 60Description: 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 60Description: 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 60The 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.
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 28Description: 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 70Description: 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 70Our 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.
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 daysDescription: 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-treatmentDescription: 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 daysDescription: Ventilator-free days to 28 days
Measure: Vent-Free Time: 28 daysDescription: Hospital-free days to 60 days
Measure: Hospital-Free Time: 60 days post-index hospitalizationThe 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.
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.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).
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.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.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).
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Recording of the number of participants who developed any cardiovascular events.
Measure: Incidence of cardiovascular events. Time: 3-6, 12 and 24 monthsDescription: 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 monthsWith 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.
Description: All cause death or invasive or non-invasive mechanical ventilation
Measure: Composite of death or mechanical ventilation Time: 28 days after randomizationDescription: (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 randomizationDescription: (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 randomizationDescription: 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±2Description: 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 daysDescription: 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 daysIn 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.
Description: Effect of Liver Injury on Mortality
Measure: 7 and 28 day mortality Time: Patients hospitalized in the ICU within 6 monthsThe 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.
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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