CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D016638: Critical Illness NIH

(Synonyms: Critical Illness)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (74)


Name (Synonyms) Correlation
drug2396 Suspension of heat killed (autoclaved) Mycobacterium w Wiki 0.16
drug2334 Standard protein group Wiki 0.14
drug1948 Pulmonary and Motor Rehabilitation Wiki 0.14
drug607 Collection of blood samples in order to create a biocollection Wiki 0.14
drug468 COVID-19 and Intensive Care Wiki 0.14
drug224 Assessment of Dietary Changes in Adults in the Quarantine Wiki 0.14
drug404 Brief educational video Wiki 0.14
drug938 File Scanning Wiki 0.14
drug1670 Observational study Wiki 0.14
drug2515 Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki 0.14
drug1145 ICU treatment Wiki 0.14
drug125 Admission to ICU for COVID-19 Wiki 0.14
drug1085 Hydroxychloroquin with Azithromycin Wiki 0.14
drug2990 risk factors Wiki 0.14
drug440 CNS magnetic resonance imaging (MRI) imaging Wiki 0.14
drug1193 Individualised Ayurveda Wiki 0.14
drug903 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.14
drug1926 Propranolol Hydrochloride Wiki 0.14
drug30 2: Standard of care Wiki 0.14
drug2800 demographic and clinical data obtained from hospital's electronic medical record. Wiki 0.14
drug690 Current care per UCLA treating physicians Wiki 0.14
drug2893 miniprobe Alveoflex Wiki 0.14
drug1969 Quality of Life Wiki 0.14
drug291 BIIB091 Wiki 0.14
drug723 Data collection from lumbar puncture Wiki 0.14
drug1187 Impact Event Score Wiki 0.14
drug859 Enoxaparin sodium Wiki 0.14
drug18 1: Naproxen Wiki 0.14
drug962 Fondapariniux Wiki 0.14
drug1144 ICU Recovery + Physical Therapy Wiki 0.14
drug2588 Umbilical Cord Mesenchymal Stem Cells Wiki 0.14
drug797 Duplex ultrasound and Computed Tomography Angiography Wiki 0.14
drug1874 Point of care ultrasound Wiki 0.14
drug850 Enhanced Usual Care Wiki 0.14
drug1072 Hospital anxiety and depression scale Wiki 0.14
drug1261 Isoflurane Inhalant Product Wiki 0.14
drug1341 LifeSignals Biosensor 1AX* Wiki 0.14
drug814 EMPOWER Wiki 0.14
drug2647 Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic Wiki 0.14
drug210 Argatroban Wiki 0.14
drug1655 Nutrition support Wiki 0.14
drug675 Covid ICU containment measures Wiki 0.14
drug2343 Standard therapy of COVID-19 Wiki 0.14
drug357 Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT) Wiki 0.14
drug2249 Sevoflurane inhalant product Wiki 0.14
drug92 AV-COVID-19 Wiki 0.14
drug722 Data collection from blood draw Wiki 0.14
drug2768 blood sampling for biobank Wiki 0.14
drug2074 Replenish protein group Wiki 0.14
drug1489 Microscopy of defined brain regions on autopsy specimens Wiki 0.14
drug2513 Thrombin Generation Assay (TGA) Wiki 0.14
drug1909 Primary care professionals reports of potential patient safety incidents, non-COVID-19 related Wiki 0.14
drug488 COVID19 Wiki 0.14
drug1817 Physiotherapy Wiki 0.10
drug1022 HB-adMSCs Wiki 0.10
drug2595 Unfractionated heparin Wiki 0.10
drug960 Follow up Wiki 0.10
drug2263 Simvastatin Wiki 0.10
drug269 Azithromycin Tablets Wiki 0.10
drug217 Aspirin Wiki 0.10
drug1930 Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki 0.08
drug603 Colchicine Tablets Wiki 0.08
drug576 Clazakizumab Wiki 0.06
drug454 COVID-19 Convalescent Plasma Wiki 0.06
drug1645 Normal saline Wiki 0.06
drug1706 Oseltamivir Wiki 0.06
drug1374 Losartan Wiki 0.05
drug2116 Ruxolitinib Wiki 0.05
drug1103 Hydroxychloroquine Sulfate Wiki 0.04
drug658 Convalescent plasma Wiki 0.04
drug1613 No intervention Wiki 0.03
drug2319 Standard of Care Wiki 0.03
drug262 Azithromycin Wiki 0.02
drug1822 Placebo Wiki 0.02

Correlated MeSH Terms (39)


Name (Synonyms) Correlation
D001927 Brain Diseases NIH 0.16
D009748 Nutrition Disorders NIH 0.14
D020196 Trauma, Nervous System NIH 0.14
D009164 Mycobacterium Infections NIH 0.14
D003147 Communication Disorders NIH 0.14
D003693 Delirium NIH 0.10
D016769 Embolism and Thrombosis NIH 0.08
D004211 Disseminated Intravascular Coagulation NIH 0.07
D013927 Thrombosis NIH 0.07
D009765 Obesity NIH 0.06
D012769 Shock, NIH 0.06
D013313 Stress Disorders, Post-Traumatic NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D055371 Acute Lung Injury NIH 0.06
D012127 Respiratory Distress Syndrome, Newborn NIH 0.06
D000066553 Problem Behavior NIH 0.05
D054556 Venous Thromboembolism NIH 0.05
D018352 Coronavirus Infections NIH 0.05
D012128 Respiratory Distress Syndrome, Adult NIH 0.05
D020246 Venous Thrombosis NIH 0.05
D011655 Pulmonary Embolism NIH 0.05
D020141 Hemostatic Disorders NIH 0.04
D004617 Embolism NIH 0.04
D001778 Blood Coagulation Disorders NIH 0.04
D013923 Thromboembolism NIH 0.04
D058186 Acute Kidney Injury NIH 0.03
D014777 Virus Diseases NIH 0.03
D040921 Stress Disorders, Traumatic NIH 0.03
D014947 Wounds and Injuries NIH 0.03
D055370 Lung Injury NIH 0.03
D001523 Mental Disorders NIH 0.03
D004194 Disease NIH 0.03
D011014 Pneumonia NIH 0.03
D001008 Anxiety Disorders NIH 0.02
D003863 Depression, NIH 0.02
D011024 Pneumonia, Viral NIH 0.02
D007239 Infection NIH 0.02
D013577 Syndrome NIH 0.02
D003141 Communicable Diseases NIH 0.01

Correlated HPO Terms (10)


Name (Synonyms) Correlation
HP:0001298 Encephalopathy HPO 0.16
HP:0005521 Disseminated intravascular coagulation HPO 0.07
HP:0001513 Obesity HPO 0.06
HP:0000708 Behavioral abnormality HPO 0.05
HP:0002625 Deep venous thrombosis HPO 0.05
HP:0002204 Pulmonary embolism HPO 0.05
HP:0001928 Abnormality of coagulation HPO 0.04
HP:0001919 Acute kidney injury HPO 0.03
HP:0001907 Thromboembolism HPO 0.03
HP:0002090 Pneumonia HPO 0.03

There are 49 clinical trials

Clinical Trials


1 Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients

Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls. Thus, interventions to improve the quality of life and care of ICU patients are needed. EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life through enhancing value-directed end-of-life care while also empowering surrogates to cope with a loved one's potential impending death and adjust following the patient's ICU death or discharge. Specifically, investigators aim to: - 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in the ICU. Key informants, including bereaved ICU patient caregivers and clinicians, will be asked to evaluate the EMPOWER intervention manual to increase its potential tolerability, acceptability and efficacy. - 2: Determine feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on surrogate mental health. - 3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU admission. Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower levels of peritraumatic distress when compared to usual care condition at post intervention assessment (T2). Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care, better quality of life, and better quality of death. EMPOWER was first evaluated though a single site open trial (n=10). Feedback from clinicians, bereaved stakeholders and results from the open trial were then used to refine the intervention and launch a multi-center randomized controlled trial to examine clinical superiority of EMPOWER to enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs of family caregivers impacted by the COVID-19 pandemic, a second single arm open trial is now occurring while the RCT recruitment is paused (total n of RCT & COVID-19 open trial=60).

NCT03276559 Critical Illness Communication Disabilities Behavioral: EMPOWER Other: Enhanced Usual Care
MeSH:Communication Disorders Critical Illness

Primary Outcomes

Description: Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Peritraumatic Distress Inventory

Time: In the week following the intervention (T2)

Secondary Outcomes

Description: Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The PG-12 consists of 12 items and total score can range from 0 to 57. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Anticipatory Grief

Time: One month and three months from baseline (T3 and T4)

Description: Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PG-13 consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Prolonged Grief Disorder

Time: One month and three months from baseline (T3 and T4)

Description: Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The BEAQ consists of 15 items and total score can range from 15 to 90. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Experiential Avoidance

Time: One month and three months from baseline (T3 and T4)

Description: Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Post-Traumatic Stress Disorder

Time: One month and three months from baseline (T3 and T4)

Other Outcomes

Description: Logistic regression models will regress patient quality of life for EMPOWER vs. the enhanced usual care condition. Patient quality of life will be assessed using three previously validated items. Total score can range from 0 to 30. Higher total scores represent better caregiver-assessed patient quality of life. Higher scores represent better outcomes.

Measure: Patient Quality of Life

Time: From baseline assessment to three-month follow up

Description: For patients who die during the study period, logistic regression models will regress patient quality of death for EMPOWER vs. the enhanced usual care condition. Quality of Death will be measured using the Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL). Total score can range from 13 to 26. Higher total scores represent better caregiver-assessed patient quality of death. Higher total scores represent better outcomes.

Measure: Patient Quality of Death

Time: From baseline assessment to three-month follow up

Description: Intensity of care (measured through indication of cardiopulmonary resuscitation, dialysis, mechanical ventilation, chemotherapy, parenteral nutrition, and palliative care in the medical record) will be matched with surrogate perceptions of patient treatment preferences to create a measure of value-concordant care. Logistic regression analyses will then model the effects of EMPOWER on the odds of patients' receipt of value-concordant care. Higher odds equal better outcomes.

Measure: Value-Concordant Care

Time: From baseline assessment to three-month follow up

Description: Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The STAI-Y state scale consists of 20 items and total score can range from 20 to 80. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Anxiety

Time: One month and three months from baseline (T3 and T4)

Description: Symptoms of anxiety, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PHQ-9 consists of 9 items and total score can range from 0 to 27. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Depression

Time: One month and three months from baseline (T3 and T4)

Description: Decision regret, as measured by the Decision Regret Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The decision regret scale is a one-item likert-style measure. Total score can range from 1 to 10. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.

Measure: Decision Regret

Time: One month and three months from baseline (T3 and T4)

2 Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool (COV_NUTRIC)

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.

NCT04274322 Critically Ill Coronavirus Infections Other: Nutrition support
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Measure: 28-day all cause mortality

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Secondary Outcomes

Measure: All cause infection

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: The rate of complications

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: Length of ICU stay

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Measure: Duration of mechanical ventilation

Time: from admission to 28-day/discharge, an average of length of ICU stay is 28-day

3 Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study

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.

NCT04285801 COVID-19
MeSH:Critical Illness

Primary Outcomes

Description: survival or death at 28 days

Measure: 28 day mortality

Time: 28 days

Secondary Outcomes

Description: days on vasopressor

Measure: vasopressor days

Time: 28 days

Description: days on mechanical ventilation during ICU stay

Measure: days on mechanical ventilation

Time: 28 days

Description: 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 days

Description: Percentage of patients requiring ECMO during ICU stay.

Measure: ECMO use

Time: 28 days

Description: percentage of patients requiring nitric oxide during ICU stay.

Measure: percentage nitric oxide use

Time: 28 days

Description: percentage not requiring oxygen therapy

Measure: percentage free from oxygen supplement

Time: 28 days

4 Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection

Infection 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.

NCT04320472 COVID-19 Encephalopathy Critically Ill Other: Follow up
MeSH:Brain Diseases Critical Illness
HPO:Encephalopathy

Primary Outcomes

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 admission

Secondary Outcomes

Description: A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review, phone call, 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 months

Description: A favorable outcome is defined by a Glasgow Outcome Scale Extended (GOSe) >= 5. The Glasgow Outcome Scale Extended (GOSe) will be determined patients charts review, phone call, and/or general practitioner interview conducted by an independent assessor. The GOSe score : [1: Death, 2: Persistent vegetative state, 3: Severe disability Lower, 4: Severe disability Upper, 5: Moderate disability Lower, 6: Moderate disability Upper, 7 : Good recovery lower, 8 : Good recovery Upper]

Measure: Favorable outcome

Time: 3 months

5 Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients

The 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

NCT04321265 COVID-19 Elderly Patients Critical Illness Survival Old Age
MeSH:Critical Illness

Primary Outcomes

Measure: Survival

Time: up to 30 days

Secondary Outcomes

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-admission

6 Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection

The 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.

NCT04325633 COVID-19 Drug: 1: Naproxen Drug: 2: Standard of care
MeSH:Critical Illness

Primary Outcomes

Measure: Mortality all causes at day30

Time: at day30

Secondary Outcomes

Measure: Number of days alive free of mechanical ventilation

Time: during 30 days after randomization

Measure: Number of days alive outside

Time: during 30 days after randomization

Measure: Number of days alive outside hospital

Time: during 30 days after randomization

Measure: Maximal changes in Sofa score

Time: in the first 7 days after randomization

Measure: Time to negativation of virus titer in the nasopharyngeal aspirate (NPA)

Time: during 90 days after randomization

7 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

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.

NCT04340466 Pneumonia, Viral Critically Ill Corona Virus Infection Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28

8 A Clinical Trial to Evaluate the Safety and Efficacy of Mycobacterium W in Critically Ill Patients Suffering From COVID 19 Infection

The 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.

NCT04347174 COVID-19 Drug: Suspension of heat killed (autoclaved) Mycobacterium w Drug: Standard therapy of COVID-19
MeSH:Mycobacterium Infections Critical Illness

Primary Outcomes

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 3

Description: 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 7

Description: 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 14

Description: 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 21

Description: 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 28

Description: 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 3

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 7

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 14

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 21

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 28

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 of transfer from ICU, if earlier than 28 days.

Secondary Outcomes

Description: All-cause mortality

Measure: All-cause mortality

Time: Till day 28

Description: 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 28

Description: 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 28

Description: ICU length of stay

Measure: ICU length of stay

Time: Till day 28

Description: Duration of mechanical ventilation

Measure: Duration of mechanical ventilation

Time: Till day 28

Description: Duration of hospitalization

Measure: Duration of hospitalization

Time: Till day 28

Description: 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 28

Description: Time (in days) from treatment initiation to death.

Measure: Time (in days) from treatment initiation to death

Time: Till day 28

9 Prospective Observational ICU Trial in Critical Ill COVID‐19 Patients (POINT-C) Cardiovascular Risk and the Effects on Myocardial Events in Critical Ill COVID-19 Patients

The aim of our study is to observe the intensive care course in 30-50 COVID-19 patients with regard to cardiovascular risk factors and biomarkers. The primary objective of this study is to investigate the cardiovascular risk and its impact on cardiovascular complications in COVID-19 patients in intensive care units. This study is designed to investigate correlations and to investigate factors influencing the course of the new viral disease COVID-19 in intensive care. Previous scientific findings are still rare due to the relevance of the disease, therefore this study is also explorative and not exclusively based on a hypothesis. The cardiovascular risk will be assessed upon admission to the intensive care unit and subsequently the course of biomarkers (see below) will be analysed in a cohort study (no, low and high cardiovascular risk).

NCT04349982 Risk Factor, Cardiovascular Covid19 Critical Illness Course Illness Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)
MeSH:Critical Illness

Primary Outcomes

Description: Troponin courses in the intensive care unit are analyzed in consideration of the respective cardiovascular risk.

Measure: ICU CV risk and Biomarker (e.g. Troponin)

Time: through study completion, up to 4 weeks

Secondary Outcomes

Description: The 30-day mortality during the ICU stay is determined and divided into appropriate cardiovascular risk groups.

Measure: CV risk and Outcome during ICU stay

Time: through study completion, up to 4 weeks

10 Epidemiology and Outcomes of Critically Ill Patients With Covid 19: a French Single Centre Experience

Since 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

NCT04354558 Epidemiology Sars-CoV2 COVID 19 Critical Care Prognostic Survival
MeSH:Critical Illness

Primary Outcomes

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 admission

Description: 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 admission

Description: 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 admission

Description: 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 admission

Description: 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 admission

11 Coagulation Assays in the Critically Ill Patient: a New Approach Using the Thrombomodulin-modified Thrombin Generation Assay (TGA-TM)

Inflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.

NCT04356144 Disseminated Intravascular Coagulation Critical Illness Sars-CoV2 Viral Infection Coagulation Disorder, Blood Covid19 Diagnostic Test: Thrombin Generation Assay (TGA) Diagnostic Test: Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)
MeSH:Infection Hemostatic Disorders Blood Coagulation Disorders Disseminated Intravascular Coagulation Critical Illness Virus Diseases
HPO:Abnormality of coagulation Abnormality of the coagulation cascade Disseminated intravascular coagulation

Primary Outcomes

Description: nM;

Measure: ETP (AUC) without rhThrombomodulin (rhTM)

Time: 6 months

Description: nM;

Measure: ETP (AUC) with rhThrombomodulin (rhTM)

Time: 6 months

Description: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM

Measure: ETP-ratio

Time: 6 months

Description: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors

Measure: ETP-Normalisation

Time: 6 months

12 The RIsk Stratification in COVID-19 Patients in the ICU Registry

The 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.

NCT04357275 Critical Illness ARDS Inflammatory Response COVID-19 Circulatory Shock Other: ICU treatment
MeSH:Critical Illness Shock

Primary Outcomes

Measure: ICU mortality

Time: During inclusion period

Secondary Outcomes

Measure: Hospital mortality

Time: During inclusion period

Measure: ICU length of stay

Time: During inclusion period

13 Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection

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.

NCT04357847 Covid-19 Endothelial Dysfunction Thrombosis Critically Ill
MeSH:Thrombosis Critical Illness

Primary Outcomes

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 hours

Secondary Outcomes

Description: 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 hours

Description: 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 hours

Description: 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 hours

Description: 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 hours

Description: 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 hours

Description: 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 hours

Description: 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 hours

14 Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

For 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

NCT04358640 Critical Illness Sars-CoV2 SARS Pneumonia Coronavirus Infection Stress Disorders, Post-Traumatic
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Critical Illness Stress Disorders, Post-Traumatic
HPO:Pneumonia

Primary Outcomes

Description: Mesured by STAY Scale

Measure: Anxiety

Time: 15 to 45 days after the beginning of the outbreak

Secondary Outcomes

Description: Participant suffering of Insomnia

Measure: Insomnia

Time: 15 to 45 days after the beginning of the outbreak

Description: Participant suffering of catastrophism

Measure: Catastrophism

Time: 15 to 45 days after the beginning of the outbreak

15 A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.

This 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.

NCT04358809 COVID-19 Drug: Suspension of heat killed (autoclaved) Mycobacterium w Other: Placebo
MeSH:Mycobacterium Infections Critical Illness

Primary Outcomes

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.

Secondary Outcomes

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 28

Description: 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.

16 Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study

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.

NCT04359914 Critical Illness COVID-19 Central Nervous System Injury Delirium Encephalopathy
MeSH:Delirium Brain Diseases Trauma, Nervous System Critical Illness
HPO:Encephalopathy

Primary Outcomes

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 90

Description: 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 28

Description: 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 90

Description: 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 90

Secondary Outcomes

Description: 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 90

Description: Cumulative days in hospital

Measure: Length of hospital stay in patients with COVID-19 compared to patients without COVID-19

Time: 1 year

Description: Survival after 90 days

Measure: 90-day survival in patients with COVID-19 compared to patients without COVID-19

Time: Day 90

17 Long Term Outcomes of Patients With COVID-19

The 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.

NCT04360538 Critical Illness Corona Virus Infection Respiratory Failure Covid-19 Other: Quality of Life Other: Impact Event Score Other: Hospital anxiety and depression scale
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Critical Illness

Primary Outcomes

Description: SF-36 score

Measure: Quality of Life score

Time: up to 12 months after discharge

Secondary Outcomes

Description: Montreal Cognitive Assessment (MoCA) score

Measure: cognitive dysfunction

Time: up to 12 months after discharge

Description: (FSS-ICU)

Measure: Functional Status Score

Time: up to 12 months after discharge

Description: MRC neuromuscular Assessment

Measure: Physical Disability

Time: up to 12 months after discharge

Description: Impact Event Score

Measure: Psychological Sequelae

Time: up to 12 months after discharge

Other Outcomes

Description: hospital anxiety and depression scale

Measure: hospital anxiety and depression

Time: up to 12 months after discharge

Description: 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 weeks

Description: measure the location (home, rehabilitation center, nursing home

Measure: hospital discharge location

Time: hospital discharge up to 6 weeks

Description: number of days admitted to the ICU

Measure: lCU length of stay

Time: hospitalization up to 6 weeks

Description: number of days admitted to the hospital

Measure: hospital length of stay

Time: hospitalization up to 6 weeks

18 A Study to Evaluate Health Behavior and Access Impacts Due to COVID-19 and for Community Engagement of Stakeholders Surrounding Scarce Resource Allocation Policy.

The novel coronavirus (COVID-19) is affecting the way many people live their lives, including seeking medical care and maintaining good self-care to keep healthy. Additionally, in the event many people become critically ill at once, COVID-19 has the possibility of overwhelming hospitals to the point where they have to make decisions about how to determine who receives intensive care and life-support measures. Many hospitals as well as local or state governments have been working on policies to determine how to make these decisions. This study seeks to learn about how COVID-19 has affected the way patients and healthcare providers care for themselves and about their thoughts and concerns about policies that may "ration" life-support resources.

NCT04373135 Covid-19 Critical Illness Attitude of Health Personnel Attitude to Health Health Behavior Health Care Utilization Behavioral: Brief educational video
MeSH:Critical Illness

Primary Outcomes

Description: Improvement in knowledge item score of 2 points on follow up after intervention delivery and at final follow up

Measure: Improvement in knowledge surrounding SRA policy

Time: 1 month, 6 months

Description: Improvement in anxiety scale of 2 points responses on follow up after intervention delivery and at final follow up

Measure: Improvement in anxiety surrounding SRA policy

Time: 1 month, 6 months

Description: Improvement in trust scale of 2 points responses on follow up after intervention delivery and at final follow up

Measure: Improvement in trust surrounding SRA policy

Time: 1 month, 6 months

19 Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

NCT04374617 COVID-19 Critical Illness Venous Thromboembolism Venous Thromboses Venous Thromboses, Deep Venous Thrombosis Pulmonary Pulmonary Embolism Pulmonary Embolism and Thrombosis Sars-CoV2 SARS-CoV Infection Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pulmonary Embolism Thrombosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Critical Illness
HPO:Deep venous thrombosis Pulmonary embolism Thromboembolism Venous thrombosis

Primary Outcomes

Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"

Measure: Venous thromboembolisms

Time: 7 days

Secondary Outcomes

Description: Deaths from all causes during the follow-up

Measure: Deaths

Time: 7 days

20 Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU

This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively. The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

NCT04378582 SARS-CoV 2 Respiratory Distress Syndrome, Adult Corona Virus Infection Critical Illness Other: risk factors
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Critical Illness

Primary Outcomes

Description: the proportion of patients who survive to ICU discharge or for 28 days in the ICU

Measure: ICU survival at 28 days

Time: 28 days

Secondary Outcomes

Description: the proportion of patients who survive to hospital discharge or for 60 days in the hospital

Measure: Hospital survival at 60 days

Time: 60 days

Description: Number of days under invasive ventilatory support

Measure: Duration of mechanical ventilation

Time: 28 days

Description: Proportion of patients who received renal replacement therapy during the ICU stay

Measure: Need for renal replacement therapy

Time: 28 days

Description: percentage of patients who developed complications during the ICU stay: thromboembolic events, ventilator associated pneumonia, secondary infections, cardiovascular complications

Measure: Complications during the ICU stay

Time: 28 days

21 Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria

This multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.

NCT04378842 Sars-CoV2 Critical Illness
MeSH:Critical Illness

Primary Outcomes

Description: percentage of patients with ICU acquired MDR bacteria colonization

Measure: Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria

Time: from D3 until day 28 after ICU admission

Secondary Outcomes

Description: percentage of patients with ICU acquired MDR bacteria infection

Measure: Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria

Time: from D3 until day 28 after ICU admission

Description: the number of days Under mechanical ventilation

Measure: Mechanical ventilation duration

Time: from D1 until day 28 after ICU admission

Description: death in the ICU

Measure: mortality

Time: from D1 until day 28 after ICU admission

Description: the number of days of hospitalization in the ICU

Measure: length of stay in intensive care unit

Time: from D1 until day 28 after ICU admission

22 Epidemiological Analysis of the Mortality of Critically Ill Patients With the COVID-19 Admitted to the Intensive Care Unit: An Observational, Prospective and Multicenter Study

The recent pandemic of the COVID-19 disease has caused a national health emergency due to its severity and the clinical and social consequences of the disease. Crude mortality in Spain is 9.2%. However, the causes of death of critically ill patients with COVID-19 are unknown. To date, no treatment has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Supportive care and isolation are recommended for infected individuals. Currently, observational studies on critically ill patients with COVID-19 have small samples. The objective is to evaluate the incidence of mortality and morbidity in COVID-19 disease in this group of critically ill patients, as well as the risk factors associated with mortality and the effectiveness of the treatments used compassionately.

NCT04379258 COVID-19 Critical Illness Effectiveness Outcome, Fatal
MeSH:Critical Illness

Primary Outcomes

Description: rate (%)

Measure: ICU mortality

Time: events during the ICU stay, up to 3 months

Secondary Outcomes

Description: rate (%)

Measure: hospital mortality

Time: events through study completion during the hospital stay, up to 5 months

Description: rate (%)

Measure: 28-day mortality

Time: events through study completion considered from ICU admission up to 28 days

Description: rate (%). Incidence of outcome measures (ICU mortality), and appearance of complications (pneumonia or bacteriemia during ICU stay).

Measure: effectiveness of treatment

Time: through study completion considered from ICU admission until ICU discharge, up to 3 months

Description: days

Measure: length of ICU stay

Time: through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented discharge or date of death from any cause, whichever came first, assessed up to 3 months

Description: days

Measure: length of hospital stay

Time: through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented hospital discharge or date of death from any cause, whichever came first, assessed up to 5 months

Description: rate (%)

Measure: ventilator-associated pneumonia

Time: through duration of invasive ventilatory support period (from intubation date until date of successful extubation) through study completion up to 3 months

Description: rate (%)

Measure: bacteriemia

Time: through study completion, up to 28-days

Description: rate (%)

Measure: barotrauma

Time: through study completion, up to 28-days

Description: days

Measure: duration of mechanical ventilation

Time: period of invasive controlled ventilatory support from date of orotraqueal intubation until date of successful extubation or assessed up to 3 months whichever came first

23 Pulmonary and Motor Rehabilitation for People With COVID-19 in Intensive Care Units to Reduce Length of Stay in Hospital

COVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.

NCT04381338 Corona Virus Disease 19 (COVID-19) COVID Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Critical Illness Other: Pulmonary and Motor Rehabilitation
MeSH:Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Critical Illness Virus Diseases

Primary Outcomes

Description: days of ICU stay

Measure: Length of ICU stay

Time: up to 60 days

Secondary Outcomes

Description: days of hospital stay

Measure: Length of hospital stay

Time: up to 90 days

24 Characteristics and Outcomes of Critically Ill Patients With Covid-19 in a Large Swedish County Hospital - a Prospective Observational Cohort Study

The study will prospectively collect data from patients with Covid-19 admitted to the Västerås Intensive Care Unit, Västerås Hospital. Demographic, clinical, radiographic and laboratory characteristics will be recorded. Analysis of data to identify predictors of disease severity, mortality and treatment response.

NCT04382417 Covid-19 Critical Illness Other: Observational study
MeSH:Critical Illness

Primary Outcomes

Measure: Demographic characteristics of patients with Covid-19 receiving intensive care

Time: Until 30 days after admittance to Intensive Care

Secondary Outcomes

Measure: Survival rate in patients with Covid-19 receiving intensive care

Time: 30 days and 6 months after admission to intensive care

Measure: Clinical course characteristics of patients with Covid-19 receiving intensive care

Time: Until 30 days after admittance to Intensive Care

Measure: Number of days on mechanical ventilation

Time: Until 30 days after admittance to Intensive Care

25 Epidemiological and Clinical Characteristics of Patients With COVID-19 Admitted in Italian Intensive Care Units: a Multicentric Retrospective-prospective Cohort Study.

Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic.

NCT04388670 COVID-19 Critical Illness
MeSH:Critical Illness

Primary Outcomes

Description: Number and characteristics of patients with COVID-19 admitted in Intensive Care Units every week.

Measure: Overall number and characteristics of patients with COVID-19 in ICU

Time: 22nd February - 22nd August 2020

26 COVID-19 in the Swedish ICU-cohort: Risk Factors of Critical Care Admission and Intensive Care Mortality

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease. By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and Angiotensin Converting Enzyme (ACE)-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

NCT04390074 COVID-19 Critical Illness Other: COVID-19 and Intensive Care
MeSH:Critical Illness

Primary Outcomes

Description: Odds ratio of intensive care treated patients with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.

Measure: Chronic medications as risk factor of intensive care for COVID-19

Time: Drug dispensation within 6 months prior inclusion

Description: Odds ratio of intensive care treated patients with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.

Measure: Comorbidities as risk factor of intensive care for COVID-19

Time: 5 years prior to inclusion

Secondary Outcomes

Description: Odds ratio of patients who have died during intensive care with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.

Measure: Chronic medications as risk factor of death during intensive care for COVID-19

Time: Drug dispensation within 6 months prior inclusion

Description: Odds ratio of patients who have died during intensive care with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.

Measure: Comorbidities as risk factor of death during intensive care for COVID-19

Time: 5 years prior to inclusion

27 Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care Requiring Invasive Ventilation: An Observational Study

This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19

NCT04396197 COVID-19 Critical Illness Ards ICU Acquired Weakness Other: Physiotherapy
MeSH:Critical Illness

Primary Outcomes

Description: Highest level of mobility achieved at the point of ICU discharge

Measure: Mobility level

Time: At ICU discharge, an average of 3 weeks

Description: Time taken to first mobilise, defined as sitting on the edge of the bed or higher

Measure: Time taken to first mobilise

Time: during ICU admission, up to 3 weeks

Secondary Outcomes

Description: Discharged to home, home with rehab, or a community rehab facility

Measure: Discharge location

Time: Hospital discharge, up to 2 months

28 The COVID-Recovery Study

Patients who are critically ill with COVID-19 requiring life support in an intensive care unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does not know what effect the disease, the ICU admission, physiotherapy interventions and life support have on their long-term quality of life and whether they can return to their pre-illness level of function following ICU. COVID-Recovery will describe the physiotherapy interventions delivered to critically ill patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU survivors to assess disability-free survival and quality of life at 3 and 6 months after ICU admission. Additionally, COVID-Recovery will identify if there are predictors of disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be invited to receive a telephone questionnaire at 3 and 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU discharge. COVID-Recovery will also aim to investigate the human aspect of COVID-19 by further investigating a sub-set of patients. COVID-Recovery will recruit between 15-30 of these patients and a family member, so COVID-Recovery can explore the patient experience of being admitted to the ICU and treated for COVID-19, as well as illuminate and explore the experience of having a close relative admitted and treated for COVID-19.

NCT04401254 COVID-19 Critical Illness
MeSH:Critical Illness

Primary Outcomes

Description: The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes

Measure: Physiotherapy intervention

Time: During the ICU stay until 3 months

Description: a composite measure of WHODAS 2.0 - 12 level and hospital survival

Measure: Disability-free survival

Time: 6 months

Secondary Outcomes

Measure: Proportion of patients with COVID-19 who received physiotherapy in ICU

Time: During the ICU stay until 3 months

Description: Physiotherapist reported barriers to delivering the intervention

Measure: The reported barriers to delivering physiotherapy interventions

Time: During the ICU stay until 3 months

Description: Adverse events that require the intervention to be ceased for medical intervention

Measure: Adverse events during physiotherapy interventions

Time: During the ICU stay until 3 months

Description: Health related quality of life measured with EQ5D-5L score from 0 to 100

Measure: Health status

Time: 6 months

Description: World Health Organization Disability Assessment Schedule 2.0 12L

Measure: Global function

Time: 6 months

Description: Montreal Cognitive Assessment Blind

Measure: Cognitive function

Time: 6 months

Description: Hospital Anxiety and Depression Scale

Measure: Anxiety and depression

Time: 6 months

Description: Impact of Events Scale Revised

Measure: Screening for post-traumatic distress

Time: 6 months

Description: WHODAS 2.0

Measure: Work Status

Time: 6 months

Description: Qualitative interviews

Measure: Phenomenological data of the patient and family experience

Time: 6 months

29 InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)

The purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.

NCT04406389 COVID-19 Drug: Enoxaparin sodium Drug: Unfractionated heparin Drug: Fondapariniux Drug: Argatroban
MeSH:Critical Illness

Primary Outcomes

Description: Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm

Measure: 30-day mortality

Time: 30 days

Secondary Outcomes

Description: Comparison of length of ICU stay in days between each treatment arm.

Measure: Length of Intensive Care Unit (ICU) Stay in Days

Time: 6 months

Description: Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm

Measure: Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events

Time: 6 months

Description: Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.

Measure: Number of major and clinically relevant non-major bleeding events

Time: 6 months

30 Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an ICU Admission for Covid-19 (OPTImAL) - a Single Center Prospective Study

Introduction: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance combining to limit physical functioning. Early data from the Covid-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Covid-19 patients surviving an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to pre-hospital level of functioning. In this present study, the investigators will evaluate the safety and feasibility of providing a novel clinical pathway combining ICU after-care at an ICU Recovery clinic with physical therapy interventions. Methods and Analysis: In this single-center, prospective (pre, post cohort) trial in patients surviving ICU admission for Covid-19. The investigators hypothesize that this novel combination is a) safe and feasible to provide for patients surviving Covid-19; b) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical battery; and c) reduce incidence of anxiety, depression and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised. Safety will be assessed by pooled adverse events and reason for early termination of interventions. Feasibility will be assessed by rate of adherence and attrition. Repeated measures ANOVA will be utilized to assess change in outcomes from at first ICU Recovery Clinic follow-up (2-weeks) and 3- and 6-months post hospital discharge. Ethics and Dissemination: The trial has received ethics approval at the University of Kentucky and enrollment has begun. The results of this trial will support the feasibility of providing ICU follow-up and physical therapy interventions for patients surviving critical illness for Covid-19 and may begin to support effectiveness of such interventions. Investigators plan to disseminate trial results in peer-reviewed journals, as well as presentation at physical therapy and critical care national and international conferences.

NCT04412330 Covid-19 Critical Illness Post Intensive Care Unit Syndrome Muscle Weakness Other: ICU Recovery + Physical Therapy
MeSH:Muscle Weakness Critical Illness

Primary Outcomes

Description: Incidence of adverse events, quantified by pain or discomfort that causes termination of interventions; a fall (with or without injury) during interventions or directly related to interventions such as fall due to fatigue; and physiologic event/abnormality that warrants termination of interventions or medical follow-up including bradycardia, tachycardia, and emergent hypertension

Measure: Adverse events (safety)

Time: through study completion, an average of 3-months

Secondary Outcomes

Description: Feasibility will be assessed by the consent rate (number of patients agreed to participate/number of patients approached for consent) and adherence attendance measured by the percentage of sessions patient participated divided total number of scheduled appointments. Adherence will also be prospectively assessed by total duration of exercise, dosage and intensity of exercises as described above. Attrition will be quantified by number of patients lost to follow-up.

Measure: Feasibility (success of consent process, adherence, and attrition)

Time: through study completion, an average of 3-months

Description: Distance walked on six-minute walk test performed in line with the ATS/ERS Guidelines as measure of exercise capacity

Measure: Six minute walk test

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Short Performance Physical Battery (SPPB) is a performance-based physical function test with components of balance, repetitive five times sit-to-stand for time, and 4-meter habitual gait speed. Higher scores on SPPB indicate better physical function.

Measure: Short Performance Physical Battery

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Health-related quality of life (HRQoL) will be measured by self-report questionnaire, the Five Dimension Euro-Quality of Life (EQ-5D) that includes a visual analog scale with rating for overall HRQoL (0-100)

Measure: Quality of life (EQ-5DL)

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Cognitive function will be assessed by the Montreal Cognitive Assessment (MOCA) with <23/30 distinguishing mild cognitive impairment. If the patient participating in telemedicine through Zoom then the MOCA-Blind version will be completed.

Measure: Cognitive function

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS), a fourteen-item scale with subset scores of >8/21 indicating anxiety or depression

Measure: Anxiety and Depression

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Distress and Post-traumatic stress disorder (PTSD) will be assessed through the Impact of Events Scale-Revised (IES-R), a 22-item self-report measure, with scores >35/88 recommending provisional diagnosis of PTSD

Measure: PTSD and distress

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: For patients previously employed, the return to work will be assessed using the self-report survey instrument designed for ICU follow-up

Measure: Return to work

Time: Assessed at baseline, and repeated 3- and 6-months post hospital discharge

Description: Readmission rate and morality with be assessed

Measure: Secondary complication

Time: Assessed 3 and 6-months post hospital discharge

31 Clinical Characteristics of Critically Ill Patients With 2019 Novel Coronavirus (COVID-19): Do We Need a New Triage System?

Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Hence, it may be need a new scoring system for contagious critically ill patients.

NCT04413435 Coronavirus Infection Critical Illness Characteristics Disease Other: File Scanning
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

Primary Outcomes

Description: To compare confirmed COVID-19 cases with suspected COVID-19 cases in critical care units.

Measure: Polymerase Chain Reaction (PCR) test

Time: 5 days

Secondary Outcomes

Description: To use symptoms, medical history, computed tomography and laboratory examinations for scoring system to detect suspected COVID-19 cases admitted to the intensive care units.

Measure: A scoring system for patients to be admitted to the intensive care unit

Time: 5 days

32 SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival. Multicentre Open-label, Pragmatic, Randomized Controlled Trial and a Parallel Prospective (Non-randomized) Cohort Study

Around1 in 4 COVID-19 patients suffer lung failure needing life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs given through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines. Another way to provide sleep is by using gases that are breathed in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies. This research is a study being carried out in a number of hospitals that will compare how well patients recover from this illness depending on which type of sedation drug they receive. The plan is to evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Finally, this trial will be a team of experts in sedation drugs who care for COVID-19 patients who need lifesaving treatments.

NCT04415060 Covid19 Drug: Isoflurane Inhalant Product Drug: Sevoflurane inhalant product
MeSH:Critical Illness

Primary Outcomes

Description: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant hospital mortality as compared to standard intravenous sedation regimen with a 10% difference between groups for 752 participants.

Measure: Hospital Mortality

Time: 2 years

Description: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant ventilation outcomes after 30 days post enrollment, as compared to standard intravenous sedation regimen for 200 participants

Measure: Ventilator-Free Days

Time: 30 days

Description: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant time spent in ICU, 30 days post enrollment, as compared to standard intravenous sedation regimen for 128 participants

Measure: ICU-Free Days

Time: 30 days

Description: Does the use of inhaled volatile anesthetic-based sedation regimen improve participant quality of life outcomes at 3 and 12 months post discharge as compared to standard intravenous sedation regimen for 144 participants. The EQ-5D questionnaire will be completed at both time points

Measure: Participant Quality of Life at 3 and 12 months after discharge

Time: 365 days

Secondary Outcomes

Description: To evaluate participant median daily oxygenation (PaO2/FiO2) at 3 days post enrollment

Measure: Median Daily Oxygenation

Time: 3 days

Description: To evaluate participant need for adjunctive ARDS therapies (prone, nitric oxide, paralysis, ECMO) during ICU stay

Measure: Adjunctive ARDS therapies

Time: 30 days

Description: To evaluate the number of hospital-free days for participants, 60 days after enrollment

Measure: Hospital-Free Days

Time: 60 days

Description: To evaluate participant disability at 3 and 12 months post discharge. The World Health Organization Disabiltity Assessment Score (WHODAS 2.0) will be completed at both timepoints. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items.

Measure: Disability

Time: 365 days

Description: Quality of Life (QALY) assessment to be calculated using the EQ-5D, comparison costs at 3 and 12 months post discharge, costs associated with hospital stay, devices and sedative costs

Measure: Cost Utility Analysis

Time: 365 days

Description: Life Year Gained (LYG) to be calculated using the EQ-5D, total costs during hospitalization, and health care utilization for 1 year after discharge.

Measure: Cost Effectiveness Analysis

Time: 365 days

33 Confirmation of Ventilation and Intubation by Determination With Ultrasonography: A Multicenter Observational Study

Chest radiography is the gold standard for confirming tracheal intubation. Bedside ultrasound can be a useful alternative. The investigators are conducting a multi-center, observational study from January 2019 to May 2020 (COVID-US Study) to determine the feasibility of tracheal and lung ultrasound in confirming endotracheal tube placement in the critically ill.

NCT04419064 Critical Illness Mechanical Ventilation Diagnostic Test: Point of care ultrasound
MeSH:Critical Illness

Primary Outcomes

Description: Adequate endotracheal tube position in agreement with chest radiograph

Measure: Concordance with next occurring chest radiograph

Time: within 24 hours

Secondary Outcomes

Description: Number of esophageal intubations detected during intubation attempt

Measure: Esophageal Intubation detection

Time: within intubation attempt

Description: Number of right main stem intubations detected with ultrasonography

Measure: Right main or endobronchial intubation

Time: within intubation attempt

34 Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France

Disproportionate impact of COVID-19 in patients with obesity is now well established. Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19. The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

NCT04425213 COVID Severe Acute Respiratory Syndrome Obesity Comorbidities and Coexisting Conditions
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Obesity Critical Illness
HPO:Obesity

Primary Outcomes

Description: number of fatal cases

Measure: ICU mortality

Time: through study completion, an average of 14 days

Secondary Outcomes

Description: number of patients with invasive mechanical ventilation

Measure: Invasive mechanical ventilation

Time: through study completion, an average of 14 days

Description: number of fatal cases

Measure: In-hospital mortality

Time: through study completion, an average of 21 days

35 Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period.

NCT04430049 Covid-19 Family Members Critical Illness Procedure: Covid ICU containment measures
MeSH:Critical Illness Depression

Primary Outcomes

Description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.

Measure: Anxiety

Time: at 3 months

Description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.

Measure: Depression

Time: at 3 months

Secondary Outcomes

Description: Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed 3 months after the ICU discharge of patient. IES-R ranges from 0 to 88; higher scores indicate worse symptoms

Measure: post-traumatic stress disorder

Time: at 3 months

36 COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units

Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.

NCT04433325 COVID-19 Intensive Care Unit Syndrome
MeSH:Critical Illness

Primary Outcomes

Description: to evaluate mortality

Measure: number of death

Time: at Intensive Care Units discharge, an average of 1 months

Secondary Outcomes

Description: to evaluate morbidity

Measure: number of infections

Time: from date of admission until Intensive Care Units discharge, assessed up to 1 months

Measure: number of days of mechanical ventilation

Time: from date of admission until Intensive Care Units discharge, assessed up to 1 months

Measure: number of days of sedation

Time: from date of admission until Intensive Care Units discharge, assessed up to 1 months

Measure: number of days of use of neuromuscular blocking agents

Time: from date of admission until Intensive Care Units discharge, assessed up to 1 months

Measure: number of days of vasopressor use

Time: from date of admission until Intensive Care Units discharge, assessed up to 1 months

Measure: number of days in Intensive Care Units

Time: from date of admission until Intensive Care Units discharge, assessed up to 1 months

Measure: number of days in hospital

Time: from date of admission until hospital discharge, assessed up to 1 months

37 Physical Rehabilitation in Intensive Care Unit in Acute Respiratory Distress Syndrome Patients With COVID-19

The primary aim of this study is to evaluate the effect of physical rehabilitation performed in intensive care unit on the range of joint motions and muscle strength of survivors following discharge from intensive care unit in patients with COVID-19. Secondary outcome is to assess the duration of mechanical ventilation, length of stay in intensive care unit and in hospital, and mortality rates during intensive care unit stay and health related quality of life following discharge in survivors. Until April 14 patients were provided all the intensive care managements except for rehabilitation and patients discharged before this time constituted the 'non-rehabilitation' group (n=17). Patients discharged after April 14 were provided rehabilitation in addition to usual intensive care unit care and constituted the study 'rehabilitation' group (n=18). Passive range of motion exercises to each joint and neuromuscular electrical stimulation to bilateral quadriceps and tibialis anterior muscles were applied 6 days/week in the 'rehabilitation' group during intensive care unit stay.

NCT04435080 COVID-19 Acute Respiratory Distress Syndrome Rehabilitation Intensive Care Unit Acquired Weakness Critical Illness Polyneuromyopathy
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome Critical Illn Critical Illness

Primary Outcomes

Description: Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients. Handgrip strength was measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.Patients were seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients were asked to grip the dynamometer with maximal effort using standard verbal encouragement. Three trials were performed in the dominant hand with a 30 sec rest between trials and the highest value was recorded in kg. The cut-off values of grip strength is 28.6 kg in men and 16.4 kg in women. The measurement was performed 1 month after discharge.

Measure: Hand grip strength

Time: 1 month after discharge from hospital

Secondary Outcomes

Description: Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best. The measurement was performed 1 month after discharge.

Measure: Short form - 36

Time: 1 month after discharge from hospital

Description: Number of days of stay in intensive care unit from admission to discharge

Measure: Length of stay in intensive care unit

Time: through study completion, an average of 3 months

Description: Number of days of stay in hospital from admission to hospital to discharge from hospital

Measure: Length of stay in hospital

Time: through study completion, an average of 3 months

Description: Number of days of invasive mechanical ventilation during intensive care unit

Measure: Duration of invasive mechanical ventilation

Time: through study completion, an average of 3 months

Description: Manual muscle strength was graded via a composite of Medical Research Council Scale score which has an excellent inter-rater reliability in survivors of critical illness. This scale range from 0 point (no muscle contraction) to 5 points (normal muscle strength). Through examination of 3 muscle groups in each limb (arm abduction, forearm flexion, wrist extension, hip flexion, knee extension and ankle dorsiflexion), clinical important muscle weakness has been defined as a composite score < 48 out of maximum 60 points. The measurement was performed 1 month after discharge.

Measure: Manual muscle strength

Time: 1 month after discharge from hospital

Description: Range of joint motion was evaluated in upper and lower extremity joints by physical examination and the results were recorded as normal or restricted for each joint. The measurement was performed 1 month after discharge.

Measure: Range of joint motion

Time: 1 month after discharge from hospital

38 The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq

Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.

NCT04441424 IMMUNOTHERAPY Biological: Convalescent plasma Drug: Hydroxychloroquin with Azithromycin
MeSH:Critical Illness

Primary Outcomes

Description: evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died

Measure: Death versus survival of treated patients

Time: Up to 8 weeks

Secondary Outcomes

Description: this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies

Measure: The length of stay in hospitals

Time: Up to 8 weeks

39 Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

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

NCT04445259 COVID Acute Kidney Injury Critical Illness
MeSH:Acute Kidney Injury Critical Illness Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

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

Measure: Incidence of any stage of acute kidney injury

Time: 14 days

Secondary Outcomes

Description: Mortality

Measure: Mortality

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

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

Measure: Renal recovery

Time: 14 days

Description: Percentage

Measure: Percentage of patients who receive renal replacement therapy

Time: 14 days

Description: Percentage of participants who are dialysis dependent

Measure: Percentage of participants who are dialysis dependent

Time: Through study completion, an average of 90 days

Description: Days without vasoactive medications and mechanical ventilation

Measure: Free-days of vasoactive medications and mechanical ventilation

Time: Day 30

Description: Length of intensive care unit and hospital stay

Measure: Length of intensive care unit and hospital stay

Time: Through study completion, an average of 90 days

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

Measure: Number of participants with consequences following AKI

Time: Through study completion, an average of 90 days

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

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

Time: Through study completion, an average of 30 days

40 Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients

The study is devoted to the comparative analysis of the data received in patients with COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of distal airways and two reference methods: high resolution computed tomography and morphology (in some patients).

NCT04451889 COVID-19 Device: miniprobe Alveoflex
MeSH:Critical Illness

Primary Outcomes

Description: pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.

Measure: Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants

Time: up to one year

Secondary Outcomes

Description: pCLE images are assessed morphometrically. Such criteria as quantity of alveolar macrophages, quantity of floating intraalveolar substances etc. are measured using a 6-point score, where zero means the absence of the symptom and 5 means the maximal expressiveness. Thickness of interalveolar septum, diameter of microvessels and thickness of elastic fibers are measured using a special tool with the included software for the endomicroscopic system. Radiologic signs e.g. low-density areas and consolidation areas are assessed in Hounsfield Units. Other radiologic signs e.g. groundglass opacity, crazy paving patterns etc. are measured by a 5-point scale, where zero means the absence of the symptom and 4 means the maximal expressiveness. The morphological analysis of the lung tissue specimens (received as a result of autopsy/transbronchial biopsy) is made according to the structures in pCLE images for 20 fields of view.

Measure: Number of Participants With the Correspondence of pCLE Images to High Resolution Computer Tomography and Morphologic Data as a Measure of Specificity and Sensitivity of the Method

Time: up to one year

41 Clinical Characteristics and Outcomes of 187 Critically Ill Patients With COVID-19

This case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.

NCT04454372 COVID-19 Other: demographic and clinical data obtained from hospital's electronic medical record.
MeSH:Critical Illness

Primary Outcomes

Description: A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized

Measure: Outcome 30 days after ICU admission

Time: 30 days after admission

42 EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT04455360 Post Traumatic Stress Disorder Intensive Care Psychiatric Disorder Anxiety Disorders Depression Critical Care COVID Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
MeSH:Disease Critical Illness Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants

Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

Time: 12 months

Secondary Outcomes

Description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms

Measure: Post-Traumatic stress disorder

Time: 6 months post-hospital discharge

Description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression

Measure: Anxiety and depression

Time: 6 months

Description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

Measure: Cognitive function

Time: 6 months post-hospital discharge

Description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

Measure: Health Related Quality of Life

Time: 6 months post-hospital discharge

Description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

Measure: Health and disability

Time: 6 months post-hospital discharge

Description: Wrist worn physical activity monitoring

Measure: Physical activity

Time: 6 months post-hospital discharge

Description: Patient generated subjective global assessment

Measure: Nutritional status

Time: 6 months post-hospital discharge

43 Application of Umbilical Cord Mesenchymal Stem Cells as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.

NCT04457609 COVID Pulmonary Infection Sars-CoV2 Drug: Oseltamivir Drug: Azithromycin Biological: Umbilical Cord Mesenchymal Stem Cells
MeSH:Critical Illness

Primary Outcomes

Description: Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate

Measure: Clinical improvement: Presence of dyspnea

Time: 15 days

Description: Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation

Measure: Clinical improvement: presence of sputum

Time: 15 days

Description: Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis

Measure: Clinical improvement: fever

Time: 15 days

Description: Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase

Measure: Clinical improvement: ventilation status

Time: 15 days

Description: Assessing the patients' blood pressure on daily basis

Measure: Clinical improvement: blood pressure

Time: 15 days

Description: Assessing the patients' heart rate on daily basis

Measure: Clinical improvement: heart rate

Time: 15 days

Description: Assessing the patients' respiratory rate on daily basis

Measure: Clinical improvement: respiratory rate

Time: 15 days

Description: Assessing the patients' oxygen saturation on daily basis

Measure: Clinical improvement: oxygen saturation

Time: 15 days

Secondary Outcomes

Description: Assessing the changes in total leukocyte upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from leukocyte level

Time: 15 days

Description: Assessing the changes in lymphocytes level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from lymphocytes level

Time: 15 days

Description: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood pH

Time: 15 days

Description: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood level of CO2

Time: 15 days

Description: Assessing the changes in blood base excess level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood base excess level

Time: 15 days

Description: Assessing the changes in blood oxygen partial pressure upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood oxygen partial pressure

Time: 15 days

Description: Assessing the changes in blood level of HCO3 upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood level of HCO3

Time: 15 days

Description: Assessing the changes in blood level of O2 saturation upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from blood level of O2 saturation

Time: 15 days

Description: Assessing the changes in level of CRP, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from level of CRP

Time: 15 days

Description: Assessing the changes in laboratory parameter, consist of SGOT/SGPT (AST/ALT) level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from level of SGOT/SGPT (AST/ALT)

Time: 15 days

Description: Assessing the changes in laboratory parameter, consist of ureum/creatinine level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of ureum/creatinine level

Time: 15 days

Description: Assessing the changes in laboratory parameter, consist of eGFR, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of eGFR

Time: 15 days

Description: Assessing the changes in level of sodium, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of sodium

Time: 15 days

Description: Assessing the changes in level of potassium, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of potassium

Time: 15 days

Description: Assessing the changes in level of chloride, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from the level of chloride

Time: 15 days

Description: Assessing the changes in procalcitonin level to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Changes in procalcitonin level

Time: 15 days

Description: Assessing the changes in albumin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from albumin level

Time: 15 days

Description: Assessing the changes in total bilirubin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: General laboratory outcome from total bilirubin level

Time: 15 days

Description: Assessing the changes in D-Dimer to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Changes in D-Dimer level

Time: 15 days

Description: Assessing the changes in fibrinogen to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Changes in fibrinogen level

Time: 15 days

Description: Assessing the changes in troponin level to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Cardiac changes from troponin level

Time: 15 days

Description: Assessing the changes in NT proBNP to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation

Measure: Cardiac changes from NT proBNP level

Time: 15 days

Description: Assessing the changes in leukemia inhibiting factor (LIF) to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in Leukemia Inhibiting Factor

Time: 7 days

Description: Assessing the changes in level of IL-6 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of IL-6

Time: 7 days

Description: Assessing the changes in level of IL-10 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of IL-10

Time: 7 days

Description: Assessing the changes in vascular endothelial growth factor (VEGF) to assess the effect of growth factors in the MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of vascular endothelial growth factor (VEGF)

Time: 7 days

Description: Assessing the changes in level of ferritin to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of ferritin

Time: 7 days

Description: Assessing the changes in level of CXCR3 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CXCR3

Time: 7 days

Description: Assessing the changes in level of CD4 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CD4

Time: 7 days

Description: Assessing the changes in level of CD8 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CD8

Time: 7 days

Description: Assessing the changes in CD56 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation

Measure: Changes in level of CD56

Time: 7 days

Description: Assessing the changes in radiology examination (Chest X-Ray/CT Scan) for any increased in lung infiltration or ground glass opacity, assessed prior to implantation and once every 3 days post-implantation

Measure: Radiologic Improvement from Chest X-Ray/CT Scan

Time: 15 days

44 Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19 During the First 60 Days of the 2020 Pandemic

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic. The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients. Data regarding baseline characteristics including comorbidities, intensive care treatments and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be calculated. The primary outcome was 30-day all-cause mortality

NCT04462393 COVID-19 Critical Illness Other: Admission to ICU for COVID-19
MeSH:Critical Illness

Primary Outcomes

Description: all-cause

Measure: 30-day mortality

Time: 30 days

Secondary Outcomes

Description: all cause

Measure: ICU mortality

Time: 30 days

45 Clinical Characteristics and Outcome in Critically Ill COVID 19 Patients

COVID19 is n outbreak with unpredictable outcome

NCT04465058 COVID19 Other: COVID19
MeSH:Critical Illness

Primary Outcomes

Description: measurements of arterial blood gas

Measure: clinical characteristics

Time: 48 hours

46 Propranolol as an Anxiolytic to Reduce the Use of Sedatives From Critically-ill Adults Receiving Mechanical Ventilation: An Open-label Randomized Controlled Trial (PROACTIVE)

The COVID-19 pandemic has led to shortages of intravenous sedatives due to increased ICU patient admissions and greater use of mechanical ventilation. A shortage of sedatives is as concerning as a shortage of mechanical ventilators since critically ill patients require sedation for comfort and to tolerate mechanical ventilation. Anti-adrenergic medications are increasingly recognized for their role in sedation of critically ill patients. Propranolol is a plentiful and inexpensive, non-selective beta-adrenergic blocker with good penetration of the blood-brain barrier, which can reduce agitation and arousal. The study team published a single-centre retrospective study of 64 mechanically-ventilated patients which found the initiation of propranolol was associated with an 86% reduction in propofol dose and a roughly 50% reduction in midazolam dose while maintaining the same level of sedation. Propranolol has the potential to mitigate the threat posed by worldwide sedative shortages and improve critical care management of patients who require mechanical ventilation. This study seeks to evaluate whether the addition of propranolol to a standard sedation regimen reduces the dose of sedative needed in critically ill patients requiring mechanical ventilation. This study is an open-label randomized controlled trial, single-blinded with 1:1 allocation. Both arms will receive sedation according to usual intensive care unit practice with a sedative agent. The intervention arm will additionally receive enteral propranolol 20-60mg q6h titrated up over 24-48h until intravenous sedative doses have fallen to a minimal level (propofol <0.5mg/kg/h or midazolam <0.5mg/h) or the maximum dose of propranolol is reached. Intravenous sedative doses will be titrated downwards in response to sympatholysis produced by the propranolol, as evidenced by a decreasing heart rate or blood pressure. The control arm will receive sedation without the addition or propranolol. The primary outcome will be the change in primary sedative dose from baseline to Day 3 of enrollment. Analysis of the primary outcome will be a difference in differences; the change in sedative dose from baseline to Day 3 in the intervention group versus the same change in the control group. The Mann-Whitney U test will be used as a nonparametric test of independent samples for this outcome.

NCT04467086 Mechanical Ventilation Sedation Critical Illness COVID Drug: Propranolol Hydrochloride
MeSH:Critical Illness

Primary Outcomes

Description: Change from baseline in total daily dose of primary sedative on Day 3

Measure: Primary sedative dose change

Time: 24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment)

Secondary Outcomes

Description: Proportion of measured sedation scores within target range (to be defined a priori by treating team): Richmond Agitation-Sedation Scale and/or the Sedation-Agitation Scale

Measure: Sedation scores

Time: Daily upon enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)

Description: Proportion of participants whose sedative dose on day 3 are below a minimum level (propofol <0.5mg/kg/h or midazolam <1.9mg/h)

Measure: Primary sedative dose

Time: Day 3 of study (60-84hrs after enrollment)

Description: Change from baseline in total daily dose of all sedatives (in mg of midazolam equivalents) on Day 3

Measure: Total sedative daily dose change

Time: 24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment)

Description: Change from baseline in total daily dose of all opioids (in mcg of fentanyl equivalents) on Day 3

Measure: Total opioid daily dose change

Time: 24 hours prior to enrollment to Day 3 of the study (60-84hrs after enrollment)

Description: Incidence of bradycardia (HR <50 or requiring intervention)

Measure: Adverse event - bradycardia

Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)

Description: Incidence of hypotension (MAP <60 requiring new vasopressor agents or an increase of >0.1 mcg/kg/min of norepinephrine or epinephrine persisting more than 2h after reducing sedative doses)

Measure: Adverse event - hypotension

Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)

Description: Incidence of clinically-important bronchospasm requiring a change in mechanical ventilation settings

Measure: Adverse event - bronchospasm

Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)

Description: Incidence of new ECG conduction delays

Measure: Adverse event - ECG conduction delays

Time: Daily from study enrollment until study completion (discharge from ICU, 28 days, or death - whichever is first)

Other Outcomes

Description: Total number of days of propranolol use

Measure: Duration of propranolol use

Time: Daily from enrollment to study withdrawal/completion (last day of propranolol dose given; discharge from ICU, 28 days, or death - whichever is first)

Description: Mean propranolol dose on day 3

Measure: Propranolol dose

Time: Day 3 of study (60-84hrs after enrollment)

Description: Mean number of ventilator-free days in first 30 days of hospital intensive care unit admission

Measure: Ventilator-free days

Time: Day 1 of admission to the intensive care unit until 30 days, discharge from intensive care, or death (whichever is first)

Description: Mean number of delirium-free days in first 30 days of hospital intensive care unit admission, measured using the Intensive Care Delirium Screening Checklist

Measure: Delirium-free days

Time: Day 1 of admission to the intensive care unit until 30 days, discharge from intensive care, or death (whichever is first)

Description: Mean length of stay in hospital

Measure: Hospital Length of Stay

Time: Day 1 of hospital admission until hospital discharge date or date of death (whichever is first)

Description: Mean length of stay in the intensive care unit

Measure: Intensive Care Unit Length of Stay

Time: Day 1 of intensive care unit admission until discharge date from intensive care unit or date of death (whichever is first)

Description: Mortality rate among participants while in hospital

Measure: Hospital Mortality

Time: Upon study completion (after all 108 participants have completed the study, estimated at 6 months) and after 50 patients have been enrolled (estimated at 3 months)

Description: Mean cost of sedative medication used in the intensive care unit among the intervention and control arms

Measure: Direct Costs

Time: Upon study completion (after all 108 participants have completed the study, estimated at 6 months)

47 Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19

This study is to analyze the microglia reaction or direct neurotropic effects of CNS COVID-19 in pathogenesis and brain stem dysfunction in critically ill patients. A microglia-focused, brain-specific 50+ marker CODEX panel is used to assess the neuroinflammatory microenvironment in specific brain regions of deceased COVID-19 patients. The peripheral (cerebrospinal fluid and peripheral blood) cytokine response to SARS-CoV-2 is investigated in regard to CNS affection and consecutive blood brain barrier disruption leading to braininherent neuroinflammatory reactions

NCT04472013 COVID-19 Disease Other: Data collection from lumbar puncture Other: Data collection from blood draw Other: CNS magnetic resonance imaging (MRI) imaging Other: Microscopy of defined brain regions on autopsy specimens
MeSH:Critical Illness

Primary Outcomes

Description: Comparison of lesions from patients that are neurologically affected to non-affected individuals in terms of CNS involvement to describe encephalitic changes due to COVID-19 infection.

Measure: MRI imaging data

Time: Project duration for each patient takes 1 hour for the MRI at baseline

Description: Description of proteomic biomarkers (CSF and Plasma) in comparison with control reference sample.

Measure: Proteomic analysis

Time: 10 minutes for blood draw at baseline

Description: Mass cytometry will be performed form peripheral blood mononuclear cells to count cell population frequency.

Measure: Peripheral blood leukocyte Cytof Mass Cytometry Analysis for cell population frequency

Time: 10 minutes for blood draw at baseline

Description: In situ distribution assessment of marker expression (CD147 protein, ACE2 protein, Transmembrane protease serine subtype 2 (TMPRSS2))

Measure: CODEX (high dimensional microscopy) workflow analysis of defined regions on brain autopsy specimens

Time: at baseline

48 Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study

Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to SARS-CoV-2 pneumonia.

NCT04473300 Critical Illness ARDS
MeSH:Pneumonia Respiratory Distress Syndrome, Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: The distribution of ventilation measured by EIT at PEEP 5 and 15.

Measure: The distribution of ventilation

Time: Through study completion (up to 24 hours)

Secondary Outcomes

Description: The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.

Measure: Silent spaces

Time: Through study completion (up to 24 hours)

Description: Respiratory system compliance in PEEP 5 and 15.

Measure: Respiratory system compliance

Time: Through study completion (up to 24 hours)

Description: Oxygenation in PEEP 5 and 15.

Measure: Oxygenation

Time: Through study completion (up to 24 hours)

Description: Dead space ventilation ratio in PEEP 5 and 15.

Measure: Dead space ventilation ratio

Time: Through study completion (up to 24 hours)

49 Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial

The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.

NCT04475666 Critical Illness Nutrition Disorders Other: Replenish protein group Other: Standard protein group
MeSH:Nutrition Disorders Critical Illness

Primary Outcomes

Description: Mortality 90 days post randomization

Measure: 90 day-all cause mortality

Time: 90 days

Secondary Outcomes

Description: use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy

Measure: Days alive at day 90 without life support

Time: 90 days

Description: 90 day survival after randomization

Measure: Days alive and out of hospital at day 90

Time: 90 days

Description: Any symptoms of bacteremia

Measure: Bacteremia until 2 days of ICU stay

Time: until 2 days post ICU.

Description: anytime during ICU stay

Measure: New or progression of Skin Pressure Ulcers

Time: ICU stay

Description: SARC-F screen for sarcopenia and EuroQoL

Measure: Functional assessment at day 90

Time: Day 90

Other Outcomes

Description: New episode of stage 2 or higher AKI by KDIGO criteria; 2. Pneumonia defined as episodes of newly confirmed pneumonia according to the modified CDC criteria; 3. Grade IV Acute Gastrointestinal injury (AGI)

Measure: Safety outcomes during ICU stay

Time: ICU stay

Description: Feeding tolerance; Diarrhoea; Refeeding syndrome

Measure: Minor safety outcomes during ICU stay

Time: ICU stay


HPO Nodes