Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical patients with serum IL-6 levels greater than the upper limit of normal
description: Phase 2
time_frame: Up to day 29
Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale reporting in severe or critical patients with all IL-6 levels
description: Phase 2
time_frame: Up to day 29
Time to resolution of fever for at least 48 hours without antipyretics in patients with documented fever
description: Phase 2
Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
Documented fever defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary)
time_frame: Up to day 29
Time to resolution of fever for at least 48 hours without antipyretics by clinical severity
description: Phase 2
Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
time_frame: Up to day 29
Time to resolution of fever for at least 48 hours without antipyretics by baseline IL-6 levels
description: Phase 2
Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
time_frame: Up to day 29
Time to improvement in oxygenation for at least 48 hours
description: Phase 2
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29
Time to improvement in oxygenation for at least 48 hours by clinical severity
description: Phase 2
Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29
Time to improvement in oxygenation for at least 48 hours by baseline IL-6 levels
description: Phase 2
Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29
Time to resolution of fever and improvement in oxygenation for at least 48 hours
description: Phase 2
Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
time_frame: Up to day 29
Mean change in the 7-point ordinal scale
description: Phase 2
time_frame: Up to day 29
Percentage of patients in each clinical status category using the 7-point ordinal scale
description: Phase 2
time_frame: Up to day 29
Time to discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours
description: Phase 2
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)
time_frame: Up to day 29
Change from baseline in NEWS2 scoring system
description: Phase 2
time_frame: Up to day 29
Number of days with fever
description: Phase 2
Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)
time_frame: Up to day 29
Proportion of patients alive, off oxygen
description: Phase 2
time_frame: At day 29
Number of days of resting respiratory rate >24 breaths/min
description: Phase 2
time_frame: Up to day 29
Number of days with hypoxemia
description: Phase 2
time_frame: Up to day 29
Number of days of supplemental oxygen use
description: Phase 2
time_frame: Up to day 29
Time to saturation ≥94% on room air
description: Phase 2
time_frame: Up to day 29
Number of ventilator free days in the first 28 days
description: Phase 2
time_frame: Baseline to day 29
Number of patients requiring initiation of mechanical ventilation
description: Phase 2
time_frame: Up to day 29
Number of patients requiring non-invasive ventilation
description: Phase 2
time_frame: Up to day 29
Number of patients requiring the use of high flow nasal cannula
description: Phase 2
time_frame: Up to day 29
Number of patients admitted into an intensive care unit (ICU)
description: Phase 2
time_frame: Up to day 29
Number of days of hospitalization among survivors
description: Phase 2
time_frame: Up to day 29
Number of deaths due to any cause
description: Phase 2
time_frame: Up to day 60
Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale
description: Phase 3
time_frame: Up to day 22
Proportion of patients who recover
description: Phase 3
Defined as discharged, or alive without supplemental oxygen use or at pre-COVID oxygen use
time_frame: Up to day 22
Proportion of deaths
description: Phase 3
time_frame: Through day 29
time_frame: Through day 60
Proportion of patients alive not receiving mechanical ventilation
description: Phase 3
time_frame: At day 22
Proportion of patients alive not requiring extracorporeal membrane oxygenation (ECMO)
description: Phase 3
time_frame: At day 22
Proportion of patients with a 2-point improvement in clinical status on the 7-point ordinal scale
description: Phase 3
time_frame: Up to day 22
Time to at least 1-point improvement in clinical status assessment on the 7-point ordinal scale
description: Phase 3
time_frame: Up to day 29
Time to at least 2-point improvement in clinical status assessment on the 7-point ordinal scale
description: Phase 3
time_frame: Up to day 29
Proportion of patients receiving mechanical ventilation
description: Phase 3
time_frame: Up to day 22
Proportion of patients receiving ECMO
description: Phase 3
time_frame: Up to day 22
Proportion of patients discharged and alive
description: Phase 3
time_frame: At day 22
Time to recovery
description: Phase 3
Defined as discharged or alive without supplemental oxygen use or at pre-COVID oxygen use
time_frame: Up to day 29
Time to death due to any cause
description: Phase 3
time_frame: Through day 60
Number of ventilator free days
description: Phase 3
time_frame: Up to day 29
Number of days of hospitalization among survivors
description: Phase 3
time_frame: Up to day 29
Proportion of patients with serious adverse events
description: Phase 2 and Phase 3
time_frame: Up to Day 29
Proportion of patients with Grade 4 neutropenia (ANC <500/mm3)
description: Phase 2 and Phase 3
time_frame: Up to day 29
Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection
description: Phase 2 and Phase 3
time_frame: Up to day 29
Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with Grade 4 neutropenia (ANC <500/mm3)
description: Phase 2 and Phase 3
time_frame: Up to day 29
Proportion of patients with hypersensitivity reactions
description: Phase 2 and Phase 3
time_frame: Up to day 29
Proportion of patients with infusion reactions
description: Phase 2 and Phase 3
time_frame: Up to day 29
Proportion of patients with gastrointestinal perforation
description: Phase 2 and Phase 3
time_frame: Up to day 29
White blood cell count
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized
Hemoglobin levels
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized
Platelet count
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized
Creatinine levels
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized
Total bilirubin level
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized
Alanine aminotransferase (ALT) level
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized
Aspartate aminotransferase (AST) level
description: Phase 2 and Phase 3
time_frame: Up to day 29 if still hospitalized [2]