Name (Synonyms) | Correlation | |
---|---|---|
drug805 | Suspension of heat killed (autoclaved) Mycobacterium w Wiki | 0.30 |
drug7 | 1: Naproxen Wiki | 0.26 |
drug667 | Quality of Life Wiki | 0.26 |
drug175 | Caption AI Wiki | 0.26 |
drug845 | Thrombin Generation Assay (TGA) Wiki | 0.26 |
drug351 | Hospital anxiety and depression scale Wiki | 0.26 |
drug14 | 2: Standard of care Wiki | 0.26 |
drug847 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.26 |
drug569 | Nutrition support Wiki | 0.26 |
drug416 | Impact Event Score Wiki | 0.26 |
drug158 | COVID-19 test, polymerase chain reaction for SARS-CoV-2 Wiki | 0.26 |
drug173 | Canakinumab Injection 600mg Wiki | 0.26 |
drug172 | Canakinumab Injection 300mg Wiki | 0.26 |
drug783 | Standard therapy of COVID-19 Wiki | 0.26 |
drug407 | ICU treatment Wiki | 0.26 |
drug339 | Halo Oral Spray Wiki | 0.26 |
drug340 | Halo Placebo Wiki | 0.26 |
drug558 | No intervention Wiki | 0.18 |
drug313 | Follow up Wiki | 0.18 |
drug632 | Placebos Wiki | 0.07 |
drug616 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D001927 | Brain Diseases NIH | 0.37 |
D009164 | Mycobacterium Infections NIH | 0.30 |
D020196 | Trauma, Nervous System NIH | 0.26 |
D003693 | Delirium NIH | 0.18 |
D013313 | Stress Disorders, Post-Traumatic NIH | 0.18 |
D004211 | Disseminated Intravascular Coagulation NIH | 0.15 |
D012769 | Shock, NIH | 0.13 |
D020141 | Hemostatic Disorders NIH | 0.13 |
D001778 | Blood Coagulation Disorders NIH | 0.13 |
D013927 | Thrombosis NIH | 0.11 |
D014777 | Virus Diseases NIH | 0.08 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.07 |
D018352 | Coronavirus Infections NIH | 0.06 |
D011024 | Pneumonia, Viral NIH | 0.04 |
D011014 | Pneumonia NIH | 0.04 |
D007239 | Infection NIH | 0.04 |
D003141 | Communicable Diseases NIH | 0.03 |
Name (Synonyms) | Correlation |
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There are 15 clinical trials
There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.
The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.
Description: survival or death at 28 days
Measure: 28 day mortality Time: 28 daysDescription: days on vasopressor
Measure: vasopressor days Time: 28 daysDescription: days on mechanical ventilation during ICU stay
Measure: days on mechanical ventilation Time: 28 daysDescription: daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function
Measure: sequential organ function assessment score Time: daily for first 5 daysDescription: Percentage of patients requiring ECMO during ICU stay.
Measure: ECMO use Time: 28 daysDescription: percentage of patients requiring nitric oxide during ICU stay.
Measure: percentage nitric oxide use Time: 28 daysDescription: percentage not requiring oxygen therapy
Measure: percentage free from oxygen supplement Time: 28 daysInfection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare. The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients. Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity. Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients. We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.
Description: ratio of patients with acute encephalopathy among the total of patients with SARS-Cov-2 infection at Critical/Intensive care or Neurocritical care admission
Measure: prevalence Time: at Critical/Intensive care or Neurocritical care admissionDescription: A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : [1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability]
Measure: Favorable outcome Time: 3 monthsThe primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group To create hypothesis for further studies, in particular on various outcome prediction To create hypothesis for further studies, in particular on various outcome prediction
Description: Fragilty will be measured by using the Clinical frailty scale (CFS) a global clinical measure of fitness and frailty in elderly people (1=very fit to 9= terminally ill)
Measure: Fragilty Time: pre-admissionThe symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Description: Mortality at day 28
Measure: Mortality at day 28 Time: day 28Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measure: severe complications Time: up to day 28Description: Delay in imaging in hours
Measure: Imaging Time: day 1Description: delay in microbiological diagnosis in hours
Measure: Delay in Microbiological diagnosis Time: day 1Description: Antiviral therapy Yes / no
Measure: Antiviral therapy Time: up to day 28Description: Antibiotic therapy Yes / No
Measure: Antibiotic therapy Time: day 28Description: Covid-19 treatments Yes / No
Measure: Covid-19 treatments Time: up to day 28Description: number
Measure: Patients receiving renal replacement therapy Time: up to day 28Description: number
Measure: Patients receiving mechanical ventilation Time: up to day 28Description: Patient alive at day 28 : yes / No
Measure: Vital status Time: day 28The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.
Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 3Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 14Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 21Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 28Description: To study the effect of Mw on recovery of organ function as assessed by Sequential Organ Failure Assessment (SOFA) scores which is based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction
Measure: Sequential Organ Failure Assessment (SOFA) scores Time: Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day of transfer from ICU, if earlier than 28 days.Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 3Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 7Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 14Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 21Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day 28Description: To study the effect of Mw on recovery of organ function as assessed by Ordinal scale
Measure: 7-category ordinal scale that ranges from 1 (not hospitalized with resumption of normal activities) to 7 (death) Time: Change in Ordinal scale from baseline to day of transfer from ICU, if earlier than 28 days.Description: All-cause mortality
Measure: All-cause mortality Time: Till day 28Description: Any AE / SAE or event of clinical significance observed during the study.
Measure: Incidence of AE / SAE or event of clinical significance Time: Till day 28Description: Percent of subjects with SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample.
Measure: SARS-CoV-2 detectable in nasal or oropharyngeal (OP) sample Time: At days 3, 7, 14, 21, and 28Description: ICU length of stay
Measure: ICU length of stay Time: Till day 28Description: Duration of mechanical ventilation
Measure: Duration of mechanical ventilation Time: Till day 28Description: Duration of hospitalization
Measure: Duration of hospitalization Time: Till day 28Description: Percentage of subjects having clinical improvement defined as two-point improvement on a seven category ordinal scale.
Measure: Clinical improvement Time: From base line at day 14 & Day 28Description: Time (in days) from treatment initiation to death.
Measure: Time (in days) from treatment initiation to death Time: Till day 28Since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS). In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU). the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2
Description: Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionDescription: Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Measure: Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU Time: from day 1 of admissionInflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 monthsDescription: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 monthsDescription: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 monthsDescription: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 monthsThe Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry was founded during the emerging SARS-CoV-2 pandemic. COVID-19 is a novel disease caused by infection with the SARS-CoV-2 virus that was first described in December 2019. The disease has spread exponentially in many countries and has reached global pandemic status within three months. According to first experience, hospitalization was required in approximately 20 % of cases and severe, life-threatening illness resulted in approximately 10 %. In some countries, health care systems were overwhelmed by the rapid increase in critically ill patients that far exceeded their capacity. It is thus of utmost importance to gain knowledge about the characteristics and course of critically ill patients with COVID-19 and to stratify these patients according to their risk for further deterioration. A key part of fighting this pandemic is to exchange scientific information and advance our understanding of the disease. The Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry aims to collect an anonymized dataset to characterize patients that develop life-threatening critical illness due to COVID-19 and make it accessible to collaborative analysis. The data collected may be composed of a core dataset and/or an extended dataset. The core dataset consists of a basic set of parameters, of which many are commonly generated during treatment of critically ill patients with COVID-19 in an intensive care unit (the individual parameters are marked yellow in the attached case report forms, and are clearly marked on the electronic case report forms during data entry). The extended dataset consists of parameters that may be measured during treatment of critically ill patients with COVID-19 in an intensive care unit, depending on clinical practice, indication and availability of the measurement method. The data accumulating in the registry as the pandemic or subsequent waves develop are made available to the collaborators to support an optimal response to the pandemic threat. The information gained on the initial characteristics and disease course via the RISC-19-ICU registry may contribute to a better understanding of the risk factors for developing critical illness due to COVID-19 and for an unfavorable disease course, and thus support informed patient triage and management decisions. Initial research questions are (I) to perform risk stratification of critically ill patients with COVID-19 to find predictors associated with the development of critical illness due to COVID-19: characterization of the study population, which are critically ill patients with COVID-19: inflammation, oxygenation, circulatory function, among other parameters collected in the registry, and (II) to perform risk stratification of critically ill patients with COVID-19 to predict outcome after ICU admission (ICU mortality, ICU length of stay): characterization of patients grouped by disease course in the ICU, based on inflammation, oxygenation, circulatory function, and other parameters collected in the registry.
The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.
Description: Plasma of covid-19 patients will be tested for endothelial injuries, notably with the measurement of InterCellular Adhesion Molecule 1 level by Enzym-Linked Immunosorbent Assay. The association of these levels with 28-days mortality will be evaluated as prognosis markers.
Measure: Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality Time: 24 hoursDescription: Endothelin-1 will be assessed in blood as a maker of endothelial injuries, expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Measure: Association of Endothelin-1 plasma level with 28 days mortality Time: 24 hoursDescription: Vascular Endothelial Growth Factor A plasma level will be measured in blood as a marker of endothelial injury expressed in pg/mL. its association with 28 -days mortality will be evaluated.
Measure: Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality Time: 24 hoursDescription: This soluble receptor is another marker of endothelial injury and will be measured in blood and expressed as pg/mL. Its association with 28-days mortality will be evaluated.
Measure: Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality Time: 24 hoursDescription: syndecan -1 is a marker of degradation of glycocalyx, raised during endothelial injury. It will be measured in blood and expressed as pg/mL. Its assocation with 28-days mortality will be evaluated.
Measure: Association of syndecan -1 plasma level with 28 days mortality Time: 24 hoursDescription: D-dimers si marker of enhanced thrombotic activity. It may be increased during covid-19 disease but its correlation with endothelial injury is not known. It will be measured in blood and expressed as microgrammes/L, and then correlated with ICAM-1 plasma levels
Measure: Association of D-dimers plasma levels with thrombotic events Time: 24 hoursDescription: This marker may be raised during endothelial injury and may explained thrombotic status of covid-19 patients. Its blood levels will be measured and expressed as international unit/dL, and correlated with ICAM-1 plasma levels
Measure: Association of von Willebrandt Factor with thrombotic events Time: 24 hoursDescription: Clot Stiffness and its fibrinogen and platelet contributions (expressed in kPa) will be measured as novative approach, using Quantra (Stago Inc) device, to explore hemostasis alterations of covid-19 patients.
Measure: Association of Viscoelastic testing with thrombotic events Time: 24 hoursFor limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed
Description: Mesured by STAY Scale
Measure: Anxiety Time: 15 to 45 days after the beginning of the outbreakDescription: Participant suffering of Insomnia
Measure: Insomnia Time: 15 to 45 days after the beginning of the outbreakDescription: Participant suffering of catastrophism
Measure: Catastrophism Time: 15 to 45 days after the beginning of the outbreakThis is a randomized, double blind, two arms, placebo controlled, clinical trial to study to evaluate the the safety and efficacy of Mycobacterium w in combination with standard of care versus placebo with standard of care for preventing the progression of COVID-19 disease and for reduction in transfer to ICU in COVID-19 infected patients admitted to the hospital.
Description: To compare the difference in proportion of patients with increased disease severity
Measure: Number of patients with increased disease severity Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To evaluate safety of Mw in COVID-19 patients admitted to hospital
Measure: Incidence of adverse events and serious adverse events (Safety) Time: Till day 28Description: To compare the proportion of patients discharged from hospital
Measure: Number of COVID-19 patients discharged from hospital Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To compare the proportion of patients transfer to ICU
Measure: Number of COVID-19 patients transfer to ICU Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
Measure: Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Description: To compare the proportion of symptom free patients
Measure: Number of of symptom free patients Time: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
Description: Assessment of neurocognitive impairment using validated tools
Measure: Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 Time: Day 90Description: Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Measure: Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline biomarker levels at day 28Description: Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Day 90Description: Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline IQCODE results at day 90Description: Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]
Measure: Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge Time: Day 90Description: Cumulative days in hospital
Measure: Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 Time: 1 yearDescription: Survival after 90 days
Measure: 90-day survival in patients with COVID-19 compared to patients without COVID-19 Time: Day 90The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.
Description: SF-36 score
Measure: Quality of Life score Time: up to 12 months after dischargeDescription: Montreal Cognitive Assessment (MoCA) score
Measure: cognitive dysfunction Time: up to 12 months after dischargeDescription: (FSS-ICU)
Measure: Functional Status Score Time: up to 12 months after dischargeDescription: MRC neuromuscular Assessment
Measure: Physical Disability Time: up to 12 months after dischargeDescription: Impact Event Score
Measure: Psychological Sequelae Time: up to 12 months after dischargeDescription: hospital anxiety and depression scale
Measure: hospital anxiety and depression Time: up to 12 months after dischargeDescription: including ventilator associated pneumonia, GI hemorrhage, Deep Vein Thrombosis (DVT) /Pulmonary Embolus (PE), sacral decubitus ulcer, delirium, ICU acquired weakness
Measure: ICU related complications Time: hospitalization up to 6 weeksDescription: measure the location (home, rehabilitation center, nursing home
Measure: hospital discharge location Time: hospital discharge up to 6 weeksDescription: number of days admitted to the ICU
Measure: lCU length of stay Time: hospitalization up to 6 weeksDescription: number of days admitted to the hospital
Measure: hospital length of stay Time: hospitalization up to 6 weeks