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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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

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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

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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

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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

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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

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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

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Primary Outcomes

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

Measure: Prevention of COVID-19

Time: Five years

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

Measure: Treatment of COVID-19

Time: Five years

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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

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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

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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

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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

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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

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Description: All unplanned reoperations will be documented

Measure: Unplanned fracture-related reoperation

Time: six months

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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

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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

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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

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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

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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

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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

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Secondary Outcomes

Description: days

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

Time: 56 days

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Description: days

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

Time: 56 days

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Description: days

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

Time: 56 days

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Description: days

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

Time: 56 days

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Description: days

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

Time: 56 days

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Description: days

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

Time: 56 days

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Description: viral load

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

Time: 56 days

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Description: days

Measure: Time until hospital discharge

Time: 56 days

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Description: days

Measure: Need for ventilatory support devices

Time: 56 days

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Description: days

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

Time: 56 days

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Description: days

Measure: COVID-19 mortality

Time: 56 days

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Description: days

Measure: all-cause mortality

Time: 56 days

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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

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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

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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

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Secondary Outcomes

Description: Mortality at 28-days by all causes

Measure: All-cause-mortality

Time: Up to 28 days

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

Measure: Acute-inflammation-free days

Time: Up to 28 days

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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

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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

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Secondary Outcomes

Description: Factors associated with worse outcome

Measure: Prognostic factors associated with death

Time: through study completion, an average of 6 months

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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.

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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.

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Primary Outcomes

Measure: Mean daily PaO2 to FiO2 ratio

Time: 10 days

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Secondary Outcomes

Measure: Duration of mechanical ventilation

Time: 30 days

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Measure: ICU length of stay

Time: 30 days

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Measure: Mortality Rate

Time: 30 days

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Measure: Incidence of adverse drug events

Time: 10 days

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Primary Outcomes

Description: Number of death during hospitalization

Measure: Number of In-Hospital Death

Time: During hospitalization, average 2-3 weeks

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Secondary Outcomes

Description: Length of stay in the hospital

Measure: Length of Stay

Time: During hospitalization, average 2-3 weeks

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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

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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

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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

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

Measure: Time on nasal cannula or oxygen masks

Time: 28 days

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Description: 28 day mortality - all cause and attributable

Measure: 28 day mortality - all cause and attributable

Time: 28 days

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Description: ICU and hospitalization length of stay (days)

Measure: ICU and hospitalization length of stay (days)

Time: 28 days

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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

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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

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Description: Vasopressor free days

Measure: Vasopressor free days

Time: 28 days

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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

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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

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

Measure: Incidence of non-lung disorders

Time: 28 days

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

Measure: Measures of liver dysfunction

Time: 28 days

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Description: Change in SCr and eGFR from baseline

Measure: Measures of kidney dysfunction

Time: 28 days

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

Measure: Measures of cardiac dysfunction

Time: 28 days

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

Measure: Measures of coagulopathies

Time: 28 days

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

Measure: Changes in immunogenic responses

Time: 28 days

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

Measure: Healthcare outcomes

Time: 28 days

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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

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Description: Pharmacokinetics of LSALT peptide over the study period.

Measure: Pharmacokinetics of LSALT peptide

Time: 28 days

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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

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Secondary Outcomes

Measure: Occurence of transient and persistent AKI

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

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Measure: Occurence of Renal replacement therapy during hospital stay

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

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Measure: Duration of renal replacement therapy

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

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Measure: Mortality

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

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Measure: Duration of mechanical ventilation

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

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Measure: Duration of vasopressor administration

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

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Measure: ICU length of stay

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

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Measure: Hospital length of stay

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

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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

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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

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Secondary Outcomes

Description: 1-month mortality

Measure: Proportion of subjects who are alive

Time: Baseline to Day 28

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Primary Outcomes

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

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

Time: Baseline, 3 month and 6 month

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Secondary Outcomes

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

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

Time: Baseline, 3 month and 6 month

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Primary Outcomes

Description: Fear of COVID-19 Questionnaire

Measure: Change in Fear of COVID-19

Time: baseline, 3 months, 6 months

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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

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Description: NeuroQol SF v1.0 - Depression

Measure: Change in depressive symptoms

Time: baseline, 3 months, 6 months

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

Measure: Change in positive affect and well-being

Time: baseline, 3 months, 6 months

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Description: NeuroQol SF v1.0 - Anxiety

Measure: Change in anxiety

Time: baseline, 3 months, 6 months

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Description: NeuroQol SF v1.0 - Fatigue

Measure: Change in fatigue

Time: baseline, 3 months, 6 months

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

Measure: Change in emotional and behavioural dyscontrol

Time: baseline, 3 months, 6 months

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Description: NeuroQol SF v1.0 - Satisfaction w SRA

Measure: Change in satisfaction with social roles and activities

Time: baseline, 3 months, 6 months

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Description: NeuroQol SF v1.0 - Sleep Disturbance

Measure: Change in sleep disturbance

Time: baseline, 3 months, 6 months

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Description: NeuroQol SF v1.0 - Stigma

Measure: Change in stigma

Time: baseline, 3 months, 6 months

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Description: NeuroQol SF v1.0 - Cognitive Function

Measure: Change in cognitive function

Time: baseline, 3 months, 6 months

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Description: 23 questions about strategies to social distance

Measure: Change in social distancing strategies used

Time: baseline, 3 months, 6 months

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Description: 22 questions about social distancing

Measure: Change in thoughts and feelings about social distancing

Time: baseline, 3 months, 6 months

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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

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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

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Secondary Outcomes

Description: Mortality

Measure: Mortality

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

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

Measure: Renal recovery

Time: 14 days

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Description: Percentage

Measure: Percentage of patients who receive renal replacement therapy

Time: 14 days

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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

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Description: Days without vasoactive medications and mechanical ventilation

Measure: Free-days of vasoactive medications and mechanical ventilation

Time: Day 30

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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

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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

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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

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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

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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

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Secondary Outcomes

Description: Survival to ICU discharge or Day 14

Measure: Survival

Time: 14 days

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

Measure: Rate of Extracorporeal Therapy Requirement

Time: 14 days

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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

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

Measure: Rate of nephrotoxic medication exposure

Time: Day of Enrollment

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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

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Primary Outcomes

Measure: In-hospital Mortality

Time: At hospital discharge, approximately 1 month

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Measure: 30-day mortality

Time: 30 days post-hospital discharge

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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

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

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

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Primary Outcomes

Description: Composite of all-cause mortality

Measure: All Cause Mortality

Time: 90 days

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Description: Need for Mechanical Ventilation

Measure: Mechanical Ventilation

Time: 90 days

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Description: Need for Mechanical Circulatory Support

Measure: Mechanical Circulatory Support

Time: 90 days

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Secondary Outcomes

Description: Time to Primary Endpoint

Measure: Time to Deterioration

Time: 90 days

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

Measure: Adverse Events

Time: 90 days

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Description: Peak Troponin Levels

Measure: Troponin

Time: 90 days

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Description: Troponin Levels Change from Baseline

Measure: Delta

Time: 90 days

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Description: Change from Baseline on BNP levels

Measure: BNP

Time: 90 days

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Description: Changes from Baseline on C Reactive Protein

Measure: Changes in C Reactive Protein

Time: 90 days

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Description: Hospital Length of Stay

Measure: LOS

Time: 90 days

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Description: Re-Hospitalization Rates

Measure: Re-Hospitalization

Time: 90 days

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Description: Changes in D Dimer from Baseline

Measure: Changes in D Dimer

Time: 90 days

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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.

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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

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Secondary Outcomes

Description: Determine the impact of nebulised heparin on oxygenation index

Measure: Oxygenation Index

Time: Up to day 10

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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

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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

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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

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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

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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

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Description: Number treated with neuromuscular blockers instituted after enrolment

Measure: Number treated with neuromuscular blockers

Time: Up to day 10

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Description: Number treated with prone positioning instituted after enrolment

Measure: Number treated with Prone positioning

Time: Up to day 10

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

Measure: Number treated with extra-corporeal membrane oxygenation

Time: Up to day 10

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Description: Number tracheotomised

Measure: Number requiring Tracheostomy

Time: Up to day 28

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Description: Time to separation from invasive ventilation among survivors

Measure: Time to separation from invasive ventilation among survivors

Time: Up to day 28

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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

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

Measure: Discharge to ward in survivors

Time: Up to day 28

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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

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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

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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

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Primary Outcomes

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

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

Time: Day 1 (Baseline) through Day 28

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Secondary Outcomes

Description: Defined as measure of safety

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

Time: Day 1 (Baseline) through Day 70

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

Measure: Change in safety laboratory parameters

Time: Day 1 (Baseline) through Day 70

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Primary Outcomes

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

Measure: pH

Time: 10 days

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

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

Time: 28 days post-treatment

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Secondary Outcomes

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

Measure: Stage 2-3 AKI

Time: 28 days

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Description: Ventilator-free days to 28 days

Measure: Vent-Free

Time: 28 days

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Description: Hospital-free days to 60 days

Measure: Hospital-Free

Time: 60 days post-index hospitalization

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