CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D014947: Wounds and Injuries NIH

(Synonyms: Wou, Woun, Wound, Wounds, Wounds, Wounds an, Wounds and, Wounds and In, Wounds and Injur, Wounds and Injuri, Wounds and Injurie, Wounds and Injuries)

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


Correlated Drug Terms (52)


Name (Synonyms) Correlation
drug1900 Non interventional study Wiki 0.19
drug148 Activity Wiki 0.19
drug508 CERC-002 Wiki 0.19
drug67 ACEIs Wiki 0.19
drug711 Collection of odour samples Wiki 0.19
drug1754 Mindful Self-Compassion Wiki 0.19
drug2825 Tacrolimus Wiki 0.19
drug380 Baricitinib or Anakinra Wiki 0.19
drug334 BCG GROUP Wiki 0.19
drug1199 Group Lifestyle Balance™ Wiki 0.19
drug275 Association of diltiazem and niclosamide Wiki 0.19
drug713 Colorectal resection Wiki 0.19
drug611 Cannabis, Medical Wiki 0.19
drug95 ARCT-021 Dose Regimen 2 Wiki 0.19
drug1390 Immunofluorescence Imaging Wiki 0.19
drug92 ARCT-021 Dose 2 Wiki 0.19
drug107 ATAFENOVIR 200 MG KAPSUL Wiki 0.19
drug97 ARFC mask Wiki 0.19
drug64 ACE inhibitor, angiotensin receptor blocker Wiki 0.19
drug2032 PLACEBO GROUP Wiki 0.19
drug289 Attention Control Group Wiki 0.19
drug104 ASTX660 Wiki 0.19
drug1846 Nebulised heparin Wiki 0.19
drug93 ARCT-021 Dose 3 Wiki 0.19
drug789 Covid-19 Standard of Care Wiki 0.19
drug94 ARCT-021 Dose Regimen 1 Wiki 0.19
drug3330 mRNA in urine test Wiki 0.19
drug88 ARBIDOL 100 MG KAPSUL Wiki 0.19
drug1581 Liver injury Wiki 0.19
drug541 COVID-19 PCR Wiki 0.19
drug91 ARCT-021 Dose 1 Wiki 0.19
drug1904 Non-Heated Vest Wiki 0.19
drug1540 LSALT peptide Wiki 0.19
drug2507 SBI-101 Wiki 0.19
drug704 Colchicine 1 MG Oral Tablet Wiki 0.19
drug1231 Heated Vest Wiki 0.19
drug8 0.9% Sodium-chloride Wiki 0.19
drug3000 Ultrasound lung imaging as part of FAST+ evaluation Wiki 0.19
drug1529 L-ascorbic acid Wiki 0.14
drug2708 Standard of care (SOC) Wiki 0.14
drug770 Conventional treatment Wiki 0.14
drug1488 Itraconazole Wiki 0.14
drug476 Brief cognitive intervention Wiki 0.14
drug1749 Midazolam Wiki 0.14
drug805 Cyclosporine Wiki 0.11
drug44 3D Telemedicine Wiki 0.11
drug1238 Heparin Wiki 0.11
drug703 Colchicine Wiki 0.06
drug1743 Methylprednisolone Wiki 0.05
drug2122 Placebo Wiki 0.04
drug1284 Hydroxychloroquine Wiki 0.04
drug313 Azithromycin Wiki 0.03

Correlated MeSH Terms (43)


Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.31
D013119 Spinal Cord Injuries NIH 0.26
D001930 Brain Injuries, NIH 0.26
D000070642 Brain Injuries, Traumatic NIH 0.22
D000070627 Chronic Traumatic Encephalopathy NIH 0.19
D000690 Amyotrophic Lateral Sclerosis NIH 0.19
D013226 Status Epilepticus NIH 0.19
D002543 Cerebral Hemorrhage NIH 0.19
D013345 Subarachnoid Hemorrhage NIH 0.19
D016472 Motor Neuron Disease NIH 0.19
D005879 Tourette Syndrome NIH 0.19
D015428 Myocardial Reperfusion Injury NIH 0.19
D015427 Reperfusion Injury NIH 0.19
D055370 Lung Injury NIH 0.19
D012640 Seizures NIH 0.14
D000755 Anemia, Sickle Cell NIH 0.14
D000068099 Trauma and Stressor Related Disorders NIH 0.14
D001714 Bipolar Disorder NIH 0.14
D005356 Fibromyalgia NIH 0.11
D040921 Stress Disorders, Traumatic NIH 0.11
D000067073 Psychological Trauma NIH 0.11
D013313 Stress Disorders, Post-Traumatic NIH 0.11
D004194 Disease NIH 0.10
D001927 Brain Diseases NIH 0.10
D010300 Parkinsonian NIH 0.10
D006470 Hemorrhage NIH 0.10
D003424 Crohn Disease NIH 0.09
D055371 Acute Lung Injury NIH 0.07
D015212 Inflammatory Bowel Diseases NIH 0.07
D059350 Chronic Pain NIH 0.07
D019966 Substance-Related Disorders NIH 0.06
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D012598 Scoliosi NIH 0.06
D009103 Multiple Sclerosis NIH 0.06
D020521 Stroke NIH 0.06
D013577 Syndrome NIH 0.04
D001523 Mental Disorders NIH 0.04
D002318 Cardiovascular Diseases NIH 0.04
D004630 Emergencies NIH 0.03
D016638 Critical Illness NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D011014 Pneumonia NIH 0.01

Correlated HPO Terms (15)


Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.31
HP:0006802 Abnormal anterior horn cell morphology HPO 0.19
HP:0002133 Status epilepticus HPO 0.19
HP:0002138 Subarachnoid hemorrhage HPO 0.19
HP:0001342 Cerebral hemorrhage HPO 0.19
HP:0007354 Amyotrophic lateral sclerosis HPO 0.19
HP:0100754 Mania HPO 0.14
HP:0001250 Seizure HPO 0.11
HP:0001298 Encephalopathy HPO 0.10
HP:0100280 Crohn's disease HPO 0.09
HP:0002037 Inflammation of the large intestine HPO 0.07
HP:0012532 Chronic pain HPO 0.07
HP:0001297 Stroke HPO 0.06
HP:0001626 Abnormality of the cardiovascular system HPO 0.04
HP:0002090 Pneumonia HPO 0.01

There are 27 clinical trials

Clinical Trials


1 Efficacy of an Evidence-based Weight-loss Intervention Post Traumatic Brain Injury

The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.

NCT03594734 Traumatic Brain Injury Behavioral: Group Lifestyle Balance™ Other: Attention Control Group
MeSH:Brain Injuries Brain Injuries, Traumatic Wounds and Injuries

Primary Outcomes

Description: Weight will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g. walker; wheelchair)

Measure: Change in weight

Time: Baseline, 3 months, 6, months, 12 months, and 18 months

Secondary Outcomes

Description: The Garmin Vivofit will be worn for the study duration to measure physical activity data.

Measure: Step Count

Time: 3 months, 6 months, 12 months, and 18 months

Description: Waist circumference will be measured at the umbilicus and mild-upper arm circumference following American College of Sports Medicine guidelines.

Measure: Waist and Arm Circumference

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded.

Measure: Blood Pressure

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Fasting venous sample will be obtained for blood glucose, HDL/LDL, cholesterol, and triglyceride level.

Measure: HbA1c and Lipid Panel

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. Each risk predictor is assigned points ranging from. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.. The age range for this score is 45 years or older, and therefore only individuals over this age will have calculated scores. Furthermore, the minimum cut-off score is 3.

Measure: Risk of Diabetes

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Satisfaction with life will be measured using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7-strongly agree to 1-strongly disagree. Scores are added together and a total score is calculated, with higher scores signifying higher satisfaction with life and lower scores signifying lower satisfaction with life.

Measure: Satisfaction with Life

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: TSH, Cortisol, IL-6, THNF, BDNF, IGF, and VEGF will be collected.

Measure: Biomarkers

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.

Measure: 10 Meter Walk Test (10MWT)

Time: Baseline, 3 months, 6 months, and 12 months

Description: Assesses distance walked (rolled for wheelchair users) over 6 minutes as a sub-maximal test of aerobic capacity.

Measure: 6 Minute Walk Test (6MWT)

Time: Baseline, 3 months, 6 months, and 12 months

Description: Social Support for Diet and Exercise Behaviors Scale is a 23-item survey including four subscales: support for healthy eating (5 items); support for physical activity (11 items); social undermining for healthy eating (5 items) and physical activity (2 items). Each item is rated on a scale of 1 to 5 (1 none; 5 very often), with respondents asked to rate support from family, friends, and coworkers. Higher scores represent greater support and internal consistency ranged from Cronbach's α 0.72-0.76.

Measure: Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: The Feasibility and Usability survey includes 14 items that assesses the participant's subjective experience with the App, level of difficulty, prompting sequence, length, and understanding. Scores above 3 on the scale (1 [totally disagree] - 5 [totally agree]) indicate that the App was easy to use.

Measure: App Feasibility and Usability using the Feasibility and Usability Survey

Time: 6 months, 12 months, and 18 months

Description: NEWS assesses residents' perception of neighborhood design features, categorized into subscales related to physical activity, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction. Subscales are scored as a mean of items. Higher scores denote higher walkability.

Measure: Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS)

Time: Baseline and 12 months

Description: Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.

Measure: Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale

Time: Baseline, 12 months, and 18 months

Description: This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.

Measure: Stressful Life Events assessed by the Holmes and Rahe Stress Inventory

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

Description: The GLB TBI/Attention Control groups will both use this app. Usage and engagement will be collected.

Measure: App Data

Time: 6 months, 12 months, and 18 months

Description: The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations. Each item on the MOCA is allocated a set of points adding up to 30.

Measure: Executive Function assessed by the Montreal Cognitive Assessment

Time: Baseline, 3 months, and 12 months

Description: Self-Report Habit Index measures self-reported perceptions of habit strength for an identified behavior. The measure has high internal reliability across four studies. The measure consists of 12 items using a 7-point Likert scale ranging from "completely disagree" to "completely agree", with higher scores representing greater perception of habit strength.

Measure: Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI)

Time: Baseline, 3 months, and 12 months

Description: The PHQ-8 is a brief self-report measure of major depressive disorder, derived from the PHQ-9 by removing the last question regarding suicide assessment.It is considered to be a valid measure of depression for population-based studies and clinical populations, and has been used in studies of patients with physical injury. Frequency of symptoms during the last 2 weeks is assessed on a 0 (not at all) to 3 (nearly every day) scale. A cut-off score of 10 or greater is considered diagnostic for current depression

Measure: Depression assessed using the Patient Health Questionnaire-8 item

Time: Baseline, 12 months, and 18 months

Description: Walk Score is publically available and measures walkability of any address using a patented system. Fore each address, Walk Score analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenities. Scores are given on a scale of 0 to 100.

Measure: Walk Score

Time: Baseline and 12 months

Description: The BAST is a 47 item, theoretically grounded, validated survey of behavioral and emotional symptoms for community-based adults with TBI. This assessment is a shortened version of the validated 77-item survey, with questions related to environmental stressors and mood removed due to repetitiveness to other questions in survey packet. Responses are asked over the past two weeks using an ordinal scale from 0 "rarely" to 5 "very often." There are 6 subscales: Negative Affect, Substance Use, Executive Function, Fatigue, Impulsivity, and Maladaptive Coping. Higher scores indicate more symptoms in those domains. This measure will be used to characterize behavioral/emotional symptoms and to explore whether these are factors that influence

Measure: Behavioral Assessment

Time: Baseline and 6 months

Description: The ten items from the General Self-Efficacy Scale (GSE) are deigned to examine goal-setting, effort investment, persistence in face of barriers and recovery from setbacks as constructs of perceived self-efficacy. The total score is the sum ranging from 10-40 and the instrument has been normed against the U.S. Adult population with a mean score of 29.48.

Measure: General Self Efficacy

Time: Baseline, 12 months, and 18 months

Description: The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.

Measure: Behavioral Risk Factor Surveillance

Time: Baseline, 3, 6, 12, and 18 months.

Description: This is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR)

Measure: MedGem

Time: Baseline

Description: The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.

Measure: Metabolic Score Calculator (MetS)

Time: Baseline, 3, 6, 12, and 18 months

Description: Information on substance use will be collected using the AUDIT-C (for alcohol use) and three questions regarding tobacco and non-prescriptive drug use.

Measure: Substance Use

Time: Baseline, 12 months

Description: This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."

Measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form

Time: Up to 12 months

Description: The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.

Measure: PROMIS Social Isolation Short Form 4a

Time: Up to 12 months

Description: To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.

Measure: Media Questionnaire

Time: Up to 12 months

2 Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons With Spinal Cord Injury

Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.

NCT03662308 Spinal Cord Injuries Device: Heated Vest Device: Non-Heated Vest
MeSH:Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Tcore will be continuously monitored throughout baseline and thermal challenge periods (with heated & non-heated vests) by a TX-2 Rectal probe and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). The probe will be placed 10 cm beyond the anal sphincter.

Measure: Change in Core Body Temperature (Tcore)

Time: Visits 2 & 3 (subjects with tetraplegia only): Continuously throughout baseline & Thermal Challenge (2 hrs) periods. The change in Tcore from baseline to the end of Thermal Challenge will be determined.

Description: The cognitive battery will be administered once at BL and once after Thermal Challenge in persons with tetraplegia only (Visits 2 & 3). Testing conditions will be identical, quiet, and distraction-free. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): Subjects will be asked to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. Each assessment requires 10 min.

Measure: Change in Cognitive Performance: WAIS-IV

Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.

Description: Delayed Recall section of the Montreal Cognitive Assessment (MoCA): Subjects will be asked to repeat 5 simple words immediately and then recall them after a 5-minute delay to assess working memory. Each assessment requires 6 min.

Measure: Change in Cognitive Performance: Delayed Recall

Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.

Description: Stroop Color and Word: Subjects will be asked to read words of colors, colors of fonts to assess attention and processing speed; color of fonts of words which describe conflicting colors to assess response inhibition (executive functioning). Subjects will practice each of the assessments for approximately 10 seconds prior to the actual test to ensure understanding of the instructions. Each assessment requires 4 min.

Measure: Change in Cognitive Performance: Stroop

Time: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined.

Secondary Outcomes

Description: Thermal Comfort will be measured every 10 minutes throughout BL and thermal challenge periods by the Zhang 6-point thermal comfort scale: +3 (very comfortable), +2 (comfortable), +1 (just comfortable), -1 (just uncomfortable), -2 (uncomfortable), and -3 (very uncomfortable). A greater frequency of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the Thermal Challenge. Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).

Measure: Change in Thermal Comfort (TC)

Time: Visits 1, 2, & 3 (all subjects): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TC from baseline to the end of Thermal Challenge will be determined.

Other Outcomes

Description: Skin thermocouples (TX-4 Skin Surface probes, Columbus Instruments, Columbus, OH) will be taped to 12 sites on the anterior trunk. Tsk data will be collected continuously throughout the baseline (BL) and Thermal Challenge periods. All areas under the vest will have skin temperatures less than or equal to 39 degrees C.

Measure: Change in Skin Temperature (Tsk) under the heated vest

Time: Visits 2 & 3 (all subjects): Continuously throughout baseline (15 min) & Thermal Challenge (2 hrs) periods. The change in Tsk from baseline to the end of Thermal Challenge will be determined.

Description: Thermal sensation will be measured on the Zhang 9-point Thermal Sensation scale: +4 (very hot), +3 (hot), +2 (warm), +1 (slightly warm), 0 (neutral), -1 (slightly cool), -2 (cool), -3 (cold), and -4 (very cold). TS should be no greater than "warm" this would include identification of "hot spots". Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).

Measure: Change in Thermal Sensation (TS)

Time: Visit 1 (able-bodied subjects only): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TS from baseline to the end of Thermal Challenge will be determined.

3 Mindful Self Compassion for Combat Deployed Veterans With Moral Injury and Co-occurring PTSD-SUD

Veterans with co-occurring Posttraumatic Stress Disorder and Substance Use Disorder (PTSD-SUD) experience more severe symptomatology and poorer response to existing treatments than Veterans with either disorder alone. Guilt is a common posttraumatic reaction and has been implicated as a risk factor for the development and maintenance of PTSD and substance use. Combat Veterans often report experiencing moral injury defined as perpetrating, failing to prevent, or witnessing acts that violate the values they live by in their civilian lives, which can lead to feelings of guilt and shame. Accordingly, reduction in guilt and increase in self-compassion may lead to improved quality of life for Veterans. This project will conduct a pilot study to evaluate changes in self-compassion, guilt, and PTSD-SUD symptom severity in a sample of Veterans after receiving 8 sessions of Mindful Self Compassion treatment (via a telehealth modality during COVID-19 pandemic). Findings will have significant impact on effective treatment options and lead to improvements in Veterans' quality of life and posttraumatic symptoms.

NCT03681288 Substance Use Disorder Post-trauma Post-traumatic Stress Disorder Moral Injury Behavioral: Mindful Self-Compassion
MeSH:Disease Substance-Related Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Wounds and Injuries

Primary Outcomes

Description: The SCS is a 26-item self-report questionnaire in which respondents describe how they relate to themselves during times of distress. The SCS includes the 5 item Self-Kindness subscale (ranging from 5-25; higher scores reflect more self-kindness), the 5-item Self-Judgment subscale (ranging from 5-25; higher scores reflect more self-judgment), the 4-item Common Humanity subscale (ranging from 4-20; higher scores reflect higher levels of common humanity), the 4-item Isolation subscale (ranging from 4-20; higher scores indicate higher levels of isolation), the 4-item Mindfulness subscale (ranging from 4-20; higher scores reflect higher levels of mindfulness) and the 4-item Over-Identification subscale (ranging from 4-20). Responses are given on a 5-point scale from "1-Almost Never" to "5-Almost Always." Mean scores on the six subscales are then averaged to create an overall self-compassion score ranging from 26 to 130. Higher scores correspond to higher levels of self-compassion.

Measure: Self-Compassion Scale (SCS); Change from baseline in Self-Compassion at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The TRGI is a 32-item validated self-report measure assessing traumatic guilt. The TRGI has three scales - Guilt Severity, Distress, and Guilt Cognitions. In all 32 items the answers are recorded on 5-point scale (ranging from 0 - not at all true to 4 - extremely true). Eight items are reverse-scored. We will use the TRGI as one of our eligibility criteria and to monitor changes in guilt and related cognitions over time.

Measure: Trauma-Related Guilt Inventory (TRGI); Change from baseline in trauma-related guilt at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The ISS is a 30-item self-report measure assessing shame proneness scored on a 5-point Likert scale ranging from 0 = "never" to 4 = "almost always". The ISS yields sum scores for two subscales, self-esteem (6 items; range = 0-24 with higher scores reflecting higher levels of self-esteem) and internalized shame (24 items; range = 0-96 with higher scores reflecting higher levels of shame) and has been well-validated with research and clinical populations. The self-esteem items are interspersed to counteract a negative response set.

Measure: Internalized Shame Scale (ISS); Change from baseline in shame at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Secondary Outcomes

Description: The CAPS is a semi-structured interview used to assess PTSD diagnostic criteria and severity. Respondents select up to three of the most traumatic events they have experienced, and those events are used as the basis for assessing PTSD symptoms. The CAPS assesses each of the 20 items from the DSM-5 criteria B, C, D, and E. The assessor combines information about frequency and intensity of an item into a single severity rating (0=Absent; 1=Mild/subthreshold; 2=Moderate/threshold; 3=Severe/markedly elevated; 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms (range = 0-40). Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20).

Measure: Clinician Administered PTSD Scale for DSM-5; Change from baseline in PTSD symptoms at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The WHO-QOL BREF is a 26-item validated self-report measure that that assesses quality of life across four domains: physical (7 items, range 1-5), psychological (6 items, range 1-5), social relationships (3 items, range 1-5), and environment (8 items, range 1-5). The four domain scores denote an individual's perception of quality of life in each particular domain. The mean score of items within each domain is used to calculate the domain score. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life on a scale of 1 - "very poor" to 5 - "very good". Question 2 asks about an individual's overall perception of their health on a scale of 1 - "very dissatisfied" to 5 - "very satisfied". The WHO-QOL-BREF has excellent internal validity and test-retest reliability.

Measure: Quality Of Life Enjoyment & Satisfaction Questionnaire (WHO-QOL-BREF); Change from baseline in quality of life at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Description: The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. The TLFB will be employed at all three assessment points to evaluate alcohol and other substance use during the 90 days preceding each interview. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period. The TLFB will be used at each follow-up to establish: percentage days heavy drinking, percent days abstinent, length of initial abstinence, length of use episodes, severity of relapse and current alcohol/drug use pattern. The Alcohol TLFB has been shown to have good psychometric characteristics with a variety of groups, and can generate variables that provide a wide range of information about an individual's use (e.g., pattern, variability, and magnitude of use).

Measure: Timeline Follow-back; Change from baseline in frequency of substance use at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

Other Outcomes

Description: Beck Scale for Suicidal Ideation (BSSI): This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week before evaluation (19). Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38 with higher score indicating more risk for suicide.

Measure: Beck Scale for Suicidal Ideation; Change from baseline in suicidal risk at post-treatment (2 mo) and follow up (3mo)

Time: Baseline, 8-10 weeks, 12-14 weeks

4 Outcomes Mandate National Integration With Cannabis as Medicine

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

NCT03944447 Chronic Pain Chronic Pain Syndrome Chronic Pain Due to Injury Chronic Pain Due to Trauma Fibromyalgia Seizures Hepatitis C Cancer Crohn Disease HIV/AIDS Multiple Sclerosis Traumatic Brain Injury Sickle Cell Disease Post Traumatic Stress Disorder Tourette Syndrome Ulcerative Colitis Glaucoma Epilepsy Inflammatory Bowel Diseases Parkinson Disease Amyotrophic Lateral Sclerosis Chronic Traumatic Encephalopathy Anxiety Depression Insomnia Autism Opioid-use Disorder Bipolar Disorder Covid19 SARS-CoV Infection Drug: Cannabis, Medical
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic Wounds and Injuries
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

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

Measure: Treatment of Symptoms

Time: Five years

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

Measure: Monitoring Adverse Events

Time: Five years

Secondary Outcomes

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

Measure: Cannabis Impact on Quality of Life

Time: Five years

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

Measure: Cannabis Route and Dosing

Time: Five years

5 ICG Fluorescence Imaging in Trauma Patients

This will be a prospective observational trial to better understand the range and variation associated with bone/soft tissue perfusion in fracture patients and examine the relationship between perfusion, measured using quantitative Indocyanine green (ICG) fluorescence and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion.

NCT04245111 Trauma Injury Other: Immunofluorescence Imaging
MeSH:Wounds and Injuries

Primary Outcomes

Description: Post-procedure surgical site infection using CDC criteria will be documented at each follow-up appointment up to six months

Measure: Post procedure surgical site infection

Time: six months

Description: All unplanned reoperations will be documented

Measure: Unplanned fracture-related reoperation

Time: six months

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

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

NCT04316299 COVID-19 Acute Kidney Injury Kidney Function
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: the incidence of Acute Kidney Injury

Measure: Rate of Acute Kidney Injury

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

Secondary Outcomes

Description: death from any cause in the hospital

Measure: Rate of Death

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

Description: days from admission to discharge or death

Measure: the length of hospital stay

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

7 The Use of Ultrasound in Establishing COVID-19 Infection as Part of a Trauma Evaluation

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

NCT04340479 COVID Trauma Ultrasound Diagnostic Test: Ultrasound lung imaging as part of FAST+ evaluation
MeSH:Wounds and Injuries

Primary Outcomes

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

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

Time: 12 months

Secondary Outcomes

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

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

Time: 12 months

8 Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19

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

NCT04341038 COVID-19 Lung Injury Drug: Tacrolimus Drug: Methylprednisolone
MeSH:Lung Injury Wounds and Injuries

Primary Outcomes

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

Measure: Time to reach clinical stability

Time: 28 days

Secondary Outcomes

Description: days

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

Time: 56 days

Description: days

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

Time: 56 days

Description: days

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

Time: 56 days

Description: days

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

Time: 56 days

Description: days

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

Time: 56 days

Description: days

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

Time: 56 days

Description: viral load

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

Time: 56 days

Description: days

Measure: Time until hospital discharge

Time: 56 days

Description: days

Measure: Need for ventilatory support devices

Time: 56 days

Description: days

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

Time: 56 days

Description: days

Measure: COVID-19 mortality

Time: 56 days

Description: days

Measure: all-cause mortality

Time: 56 days

Description: cytokines quantification technique by Luminex

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

Time: 56 days

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

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

Time: 56 days

9 Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (EVICT-CORONA-ALI)

This study will test to see if a 72-hour intravenous vitamin C infusion protocol (100 mg/kg every 8 hours) in patients with hypoxemia and suspected COVID-19 will reduce the lung injury caused by the SARS-Cov-2.

NCT04344184 COVID-19 Lung Injury, Acute Drug: L-ascorbic acid Other: Placebo
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

Description: Documented days free off mechanical ventilation the first 28 days post enrollment

Measure: Number of ventilator-free days

Time: Up to 28 days

Secondary Outcomes

Description: Mortality at 28-days by all causes

Measure: All-cause-mortality

Time: Up to 28 days

Description: Number of days free of acute inflammation (defined as CRP >= 10 mg/L)

Measure: Acute-inflammation-free days

Time: Up to 28 days

Description: Number of days that the participant is free of organ failure in ALL of the following organ systems: Cardiovascular, Respiratory, Neurological, Liver, Bone marrow organ, Renal

Measure: Organ-failure-free days

Time: Up to 1 year

10 Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors

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

NCT04358380 Liver Injury Other: Liver injury
MeSH:Wounds and Injuries

Primary Outcomes

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

Measure: Liver injury in patients with COVID-19

Time: through study completion, an average of 6 months

Secondary Outcomes

Description: Factors associated with worse outcome

Measure: Prognostic factors associated with death

Time: through study completion, an average of 6 months

Description: Description of patients hospitalized with COVID-19

Measure: Clinical characteristics of patients who developed liver injury

Time: through study completion, an average of 6 months

11 Prospective Parallel-Group Study of the Relationship Between Kidney Injury Severity and Severity of COVID-19

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

NCT04386564 COVID-19 Kidney Injury Diagnostic Test: mRNA in urine test
MeSH:Wounds and Injuries

Primary Outcomes

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

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

Time: 2 months

Secondary Outcomes

Description: viral RNA concentration in urine, ME/ml

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

Time: 2 months

Description: albumine excretion with urine, g/ml

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

Time: 2 months

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

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

Time: 2 months

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

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

Time: 2 months

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

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

Time: 2 months

12 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Test of Replication to a New Population

This research study is designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention includes a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.

NCT04394156 Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma, Psychological Trauma and Stressor Related Disorders Mental Disorder Behavioral: Brief cognitive intervention
MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Disorders Psychological Trauma Trauma and Stressor Related Disorders Wounds and Injuries

Primary Outcomes

Description: Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.

Measure: Frequency of intrusive memories

Time: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. Change is assessed from baseline to post-intervention.

Secondary Outcomes

Description: A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.

Measure: Concentration

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.

Measure: Social and Occupational Activity Tally (SOAT)

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.

Measure: Dissociation

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.

Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

Time: Baseline and 2-weeks post-intervention

Description: The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.

Measure: Patient Health Questionnaire (PHQ-9)

Time: Baseline and 2-weeks post-intervention

Description: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.

Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version

Time: Baseline and 2-weeks post-intervention

Other Outcomes

Description: A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.

Measure: Self-Guided Intervention Adherence Questionnaire

Time: Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.

Description: A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.

Measure: Feedback Questionnaire

Time: 1-week post-intervention.

13 Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury

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

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

Primary Outcomes

Measure: Mean daily PaO2 to FiO2 ratio

Time: 10 days

Secondary Outcomes

Measure: Duration of mechanical ventilation

Time: 30 days

Measure: ICU length of stay

Time: 30 days

Measure: Mortality Rate

Time: 30 days

Measure: Incidence of adverse drug events

Time: 10 days

14 Association of Early Myocardial Injury With Major Adverse Outcomes in Patients With COVID-19

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

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

Primary Outcomes

Description: Number of death during hospitalization

Measure: Number of In-Hospital Death

Time: During hospitalization, average 2-3 weeks

Secondary Outcomes

Description: Length of stay in the hospital

Measure: Length of Stay

Time: During hospitalization, average 2-3 weeks

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

Measure: Number of Successful Treatment

Time: During hospitalization, average 2-3 weeks

15 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)

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

NCT04402957 COVID Severe Acute Respiratory Syndrome Sars-CoV2 Acute Kidney Injury Drug: LSALT peptide Drug: Placebo
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Acute Kidney Injury Syndrome Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

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

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

Time: 28 days

Secondary Outcomes

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

Measure: Ventilation-free days

Time: 28 days

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

Measure: Time on nasal cannula or oxygen masks

Time: 28 days

Description: 28 day mortality - all cause and attributable

Measure: 28 day mortality - all cause and attributable

Time: 28 days

Description: ICU and hospitalization length of stay (days)

Measure: ICU and hospitalization length of stay (days)

Time: 28 days

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

Measure: SARS-CoV2 testing

Time: 28 days

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

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

Time: 28 days

Description: Vasopressor free days

Measure: Vasopressor free days

Time: 28 days

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

Measure: Radiographic pulmonary assessments

Time: 28 days

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

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

Time: 28 days

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

Measure: Incidence of non-lung disorders

Time: 28 days

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

Measure: Measures of liver dysfunction

Time: 28 days

Description: Change in SCr and eGFR from baseline

Measure: Measures of kidney dysfunction

Time: 28 days

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

Measure: Measures of cardiac dysfunction

Time: 28 days

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

Measure: Measures of coagulopathies

Time: 28 days

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

Measure: Changes in immunogenic responses

Time: 28 days

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

Measure: Healthcare outcomes

Time: 28 days

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

Measure: Molecular changes in pro-inflammatory pathways

Time: 28 days

Description: Pharmacokinetics of LSALT peptide over the study period.

Measure: Pharmacokinetics of LSALT peptide

Time: 28 days

16 Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

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

NCT04406688 Acute Kidney Injury COVID-19 ARDS
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

Description: Occurence of moderate or severe AKI

Measure: Occurence of acute kidney injury (AKI)

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

Secondary Outcomes

Measure: Occurence of transient and persistent AKI

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

Measure: Occurence of Renal replacement therapy during hospital stay

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

Measure: Duration of renal replacement therapy

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

Measure: Mortality

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

Measure: Duration of mechanical ventilation

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

Measure: Duration of vasopressor administration

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

Measure: ICU length of stay

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

Measure: Hospital length of stay

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

Other Outcomes

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

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

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

17 A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults With COVID 19 Pneumonia and Acute Lung Injury

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

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

Primary Outcomes

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

Measure: Proportion of patient alive and free of respiratory failure

Time: Baseline to Day 28

Secondary Outcomes

Description: 1-month mortality

Measure: Proportion of subjects who are alive

Time: Baseline to Day 28

18 Tracking Needs of Persons With a Spinal Cord Injury (SCI) During the COVID-19 Pandemic

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

NCT04422769 Spinal Cord Injuries
MeSH:Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

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

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

Time: Initial, 3 month and 6 month

Secondary Outcomes

Description: A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever, some of the time, or often. This study will use the measure to determine if people feel socially isolated during a pandemic.

Measure: UCLA 3-item Loneliness Scale - change in social isolation

Time: Initial, 3 month and 6 month

19 COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

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

NCT04426071 Brain Injuries Stroke Spinal Cord Injuries
MeSH:Brain Injuries Spinal Cord Injuries Wounds and Injuries

Primary Outcomes

Description: Fear of COVID-19 Questionnaire

Measure: Change in Fear of COVID-19

Time: baseline, 3 months, 6 months

Secondary Outcomes

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

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

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Depression

Measure: Change in depressive symptoms

Time: baseline, 3 months, 6 months

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

Measure: Change in positive affect and well-being

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Anxiety

Measure: Change in anxiety

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Fatigue

Measure: Change in fatigue

Time: baseline, 3 months, 6 months

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

Measure: Change in emotional and behavioural dyscontrol

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Satisfaction w SRA

Measure: Change in satisfaction with social roles and activities

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Sleep Disturbance

Measure: Change in sleep disturbance

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Stigma

Measure: Change in stigma

Time: baseline, 3 months, 6 months

Description: NeuroQol SF v1.0 - Cognitive Function

Measure: Change in cognitive function

Time: baseline, 3 months, 6 months

Description: 23 questions about strategies to social distance

Measure: Change in social distancing strategies used

Time: baseline, 3 months, 6 months

Description: 22 questions about social distancing

Measure: Change in thoughts and feelings about social distancing

Time: baseline, 3 months, 6 months

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

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

NCT04445220 COVID-19 Acute Kidney Injury Biological: SBI-101
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

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

Time: Outcomes and Serious Adverse Events through Day 180

21 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

22 Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

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

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

Primary Outcomes

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

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

Time: 7 months

23 SARS-CoV2 Pediatric Acute Kidney Injury Registry and Collaborative

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

NCT04466306 Acute Kidney Injury COVID
MeSH:Acute Kidney Injury Wounds and Injuries
HPO:Acute kidney injury

Primary Outcomes

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

Measure: Acute Kidney Injury (AKI)

Time: 14 days

Secondary Outcomes

Description: Survival to ICU discharge or Day 14

Measure: Survival

Time: 14 days

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

Measure: Rate of Extracorporeal Therapy Requirement

Time: 14 days

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

Measure: Fluid overload

Time: Day of Enrollment

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

Measure: Rate of nephrotoxic medication exposure

Time: Day of Enrollment

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

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

NCT04479124 Trauma Covid19 Diagnostic Test: COVID-19 PCR
MeSH:Emergencies Wounds and Injuries

Primary Outcomes

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

Measure: trauma admissions

Time: 3 months

25 Severe Neurologic Injury Outcomes During COVID-19 Crisis

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

NCT04496076 Sars-CoV2 Severe Neurologic Injury Ischemic Stroke Hemorrhagic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage Traumatic Brain Injury Status Epilepticus
MeSH:Stroke Brain Injuries Brain Injuries, Traumatic Subarachnoid Hemorrhage Cerebral Hemorrhage Status Epilepticus Hemorrhage Wounds and Injuries
HPO:Cerebral hemorrhage Status epilepticus Stroke Subarachnoid hemorrhage

Primary Outcomes

Measure: In-hospital Mortality

Time: At hospital discharge, approximately 1 month

Measure: 30-day mortality

Time: 30 days post-hospital discharge

Secondary Outcomes

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

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

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

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

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

26 Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

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

NCT04510038 Covid19 Myocardial Injury Drug: Colchicine Other: Covid-19 Standard of Care
MeSH:Wounds and Injuries

Primary Outcomes

Description: Composite of all-cause mortality

Measure: All Cause Mortality

Time: 90 days

Description: Need for Mechanical Ventilation

Measure: Mechanical Ventilation

Time: 90 days

Description: Need for Mechanical Circulatory Support

Measure: Mechanical Circulatory Support

Time: 90 days

Secondary Outcomes

Description: Time to Primary Endpoint

Measure: Time to Deterioration

Time: 90 days

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

Measure: Adverse Events

Time: 90 days

Description: Peak Troponin Levels

Measure: Troponin

Time: 90 days

Description: Troponin Levels Change from Baseline

Measure: Delta

Time: 90 days

Description: Change from Baseline on BNP levels

Measure: BNP

Time: 90 days

Description: Changes from Baseline on C Reactive Protein

Measure: Changes in C Reactive Protein

Time: 90 days

Description: Hospital Length of Stay

Measure: LOS

Time: 90 days

Description: Re-Hospitalization Rates

Measure: Re-Hospitalization

Time: 90 days

Description: Changes in D Dimer from Baseline

Measure: Changes in D Dimer

Time: 90 days

27 Can Nebulised HepArin Reduce acuTE Lung Injury in Patients With SARS-CoV-2 Requiring Mechanical Ventilation in Ireland

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

NCT04511923 Covid19 ARDS, Human Lung Injury, Acute Ventilation Perfusion Mismatch Drug: Nebulised heparin
MeSH:Lung Injury Acute Lung Injury Respiratory Distress Syndrome, Adult Wounds and Injuries

Primary Outcomes

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

Measure: D-dimer profile

Time: Up to day 10.

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

Measure: Frequenccy of Severe Adverse Outcomes

Time: Up to day 60

Secondary Outcomes

Description: Determine the impact of nebulised heparin on oxygenation index

Measure: Oxygenation Index

Time: Up to day 10

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

Measure: Indices of Inflammation

Time: Up to day 10

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

Measure: Ratios of Indices of Inflammation

Time: Up to day 10

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

Measure: Indices of Coagulation

Time: Up to day 10

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

Measure: Quasi-Static Lung Compliance

Time: Up to day 10

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

Measure: Time to separation from invasive ventilation

Time: Up to day 28

Description: Number treated with neuromuscular blockers instituted after enrolment

Measure: Number treated with neuromuscular blockers

Time: Up to day 10

Description: Number treated with prone positioning instituted after enrolment

Measure: Number treated with Prone positioning

Time: Up to day 10

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

Measure: Number treated with extra-corporeal membrane oxygenation

Time: Up to day 10

Description: Number tracheotomised

Measure: Number requiring Tracheostomy

Time: Up to day 28

Description: Time to separation from invasive ventilation among survivors

Measure: Time to separation from invasive ventilation among survivors

Time: Up to day 28

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

Measure: Discharge to ward

Time: Up to day 28

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

Measure: Discharge to ward in survivors

Time: Up to day 28

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

Measure: Patient Survival

Time: Up to day 60

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

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

Time: Up to day 60

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

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

Time: Up to day 60


HPO Nodes