Correlated Drug Terms (2)

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	Name (Synonyms)	Correlation
drug2527	Tocilizumab Wiki	0.19
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (2)

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	Name (Synonyms)	Correlation
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Number of participants with treatment emergent adverse events will be evaluated as a measure of safety and tolerability of OP-101 by monitoring and documenting all adverse events, which include laboratory test variables.

Measure: Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0

Time: Up to Day 60

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Secondary Outcomes

Description: WHO-7 is a 7 point ordinal scale for clinical improvement with scores ranging from 0 to 7 where 0= uninfected, 1= no limitation of activities (ambulatory), 2= limitation of activities (ambulatory), 3= hospitalized, no oxygen therapy (hospitalized mild disease), 4= Hospitalized, oxygen by mask or nasal prongs (hospitalized mild disease), 5= Hospitalized, noninvasive ventilation or high-flow oxygen (hospitalized severe disease), 6= Hospitalized, intubation and mechanical ventilation (hospitalized severe disease), 7= Hospitalized, ventilation + additional organ support - pressors, renal replacement therapy, ECMO.

Measure: Time to Improvement (2 points) in Clinical Status Assessment Using the World Health Organization 7-Point Ordinal Scale (WHO 7OS)

Time: Up to Day 30

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Measure: Time to Resolution of Fever for at least 48 hours Without Antipyretics for Patients with Documented Fever (>=37.2 degree celsius [oral], or >=37.8 degree celsius [rectal], or >=38.0 degree celsius [tympanic])

Time: Up to Day 30

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Description: Improvement in oxygenation is defined by increase in pulse oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) of >=50 compared with nadir SpO2/FiO2.

Measure: Time to Improvement in Oxygenation for at least 48 hours

Time: Up to Day 30

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Description: WHO-7 is a 7 point ordinal scale for clinical improvement with scores ranging from 0 to 7 where 0= uninfected, 1= no limitation of activities (ambulatory), 2= limitation of activities (ambulatory), 3= hospitalized, no oxygen therapy (hospitalized mild disease), 4= Hospitalized, oxygen by mask or nasal prongs (hospitalized mild disease), 5= Hospitalized, noninvasive ventilation or high-flow oxygen (hospitalized severe disease), 6= Hospitalized, intubation and mechanical ventilation (hospitalized severe disease), 7= Hospitalized, ventilation + additional organ support - pressors, renal replacement therapy, ECMO.

Measure: Change from Baseline in the World Health Organization (WHO)-7 Point Ordinal Scale

Time: Baseline up to Day 30

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Description: NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C).

Measure: Time to Discharge from Clinic or Hospital or to National Early Warning Score 2 (NEWS2) of <=2 and maintained for 24 hours

Time: Up to Day 30

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Measure: Percentage of Patients Alive and not Using Supplemental Oxygen at Time of Discharge from Hospital/Clinic or Day 30

Time: Up to Day 30

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Measure: Number of Days of Resting Respiratory Rate of more than 24 breath/min

Time: Up to Day 30

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Description: Hypoxemia is defined by Saturation of Peripheral Oxygen (SpO2) of less than (<) 95 percent (%) on room air or acute respiratory distress syndrome (ARDS).

Measure: Number of Days with Hypoxemia

Time: Up to Day 30

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Measure: Number of Days of Supplemental Oxygen use

Time: Up to Day 30

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Measure: Number of Ventilator-free Days

Time: Up to Day 28

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Measure: Number of Days in Intensive Care Unit (ICU)

Time: Up to Day 30

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Measure: Number of Days of Hospitalization for Survivors

Time: Up to Day 30

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Measure: Number of Participants with all cause deaths

Time: Up to Day 30

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Description: Percent change from baseline in proinflammatory cytokines (C-reactive protein [CRP], ferritin, and interleukin-6 [IL-6]) will be reported.

Measure: Percent change from baseline in Proinflammatory Cytokines

Time: Baseline up to Day 30

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Measure: Incidence of Drug-related Serious Adverse Events (SAEs)

Time: Up to Day 60

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