Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug10	0.9% sodium chloride (normal saline) Wiki	1.00

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D018450	Disease Progression NIH	0.26

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale which measures the clinical status of a subject at the first assessment of a given day with category 1, most favorable, and category 8, least favorable (1. Ambulatory, no limitation of activities; 2. Ambulatory, limitation of activities; 3. Hospitalized, no oxygen therapy; 4. Hospitalized, oxygen by mask or nasal prongs; 5. Hospitalized, non-invasive ventilation or high-flow oxygen; 6. Hospitalized, intubation and mechanical ventilation; 7. Hospitalized, ventilation plus additional organ support - pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]; 8. Death)

Measure: Evaluate the effect of RBT-9 versus placebo on clinical status of COVID-19 patients as measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale

Time: 28 days

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Secondary Outcomes

Description: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through Day 28, defined as at least one of the following: 1. Respiratory decompensation; 2. New or worsening congestive heart failure; 3. Requirement of vasopressor therapy and/or inotropic or mechanical circulatory support; 4. Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest; 5. Initiation of renal replacement therapy

Measure: Time to first occurrence of death from any cause or new/worsened organ dysfunction

Time: 28 Days

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Description: Percentage of subjects who are alive at Day 28

Measure: All-cause survival

Time: 28 Days

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Description: Among subjects who begin oxygen therapy, mean change from initiation to last day on oxygen or Day 28 (whichever happens first) in SpO2/FiO2 ratio

Measure: Oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio

Time: 28 Days

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Description: Percentage of subjects with fever through Day 28

Measure: Fever incidence

Time: 28 Days

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Description: Percentage of subjects who develop AKI (defined as an increase in serum creatinine by 0.5 mg/dL or more within 48 hours or an increase in serum creatinine to 1.5 × Baseline or more within the last 7 days) through Day 28

Measure: Acute kidney injury (AKI) incidence

Time: 28 Days

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Description: Percentage of subjects with new or worsening congestive HF through Day 28

Measure: New or worsening congestive heart failure (HF)

Time: 28 Days

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Description: Percentage of subjects who remain hospitalized at Day 28

Measure: Hospitalization status

Time: 28 Days

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Description: Percentage of subjects with ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest through Day 28

Measure: Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest

Time: 28 Days

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Description: Number of oxygen-free days through Day 28

Measure: Oxygen-free days

Time: 28 Days

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Description: Percentage of subjects transferred to the ICU through Day 28

Measure: Intensive care unit (ICU) status

Time: 28 Days

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Description: Number of days on mechanical ventilation through Day 28

Measure: Days on ventilator

Time: 28 Days

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Description: Time to and duration of vasopressor or inotrope utilization through Day 28

Measure: Time to and duration of vasopressor or inotrope utilization

Time: 28 Days

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Description: Percentage of subjects who begin dialysis through Day 28

Measure: Dialysis status

Time: 28 Days

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