Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percentage of Participants Alive and Without Respiratory Failure Through Day 28 |
Respiratory failure is defined as a clinical diagnosis of respiratory failure and initiation of one of the following therapies: endotracheal intubation and mechanical ventilation; OR extracorporeal membrane oxygenation; OR high-flow nasal cannula oxygen delivery (i.e., reinforced nasal cannula delivering heated, humidified oxygen with fraction of delivered oxygen = 0.5 and flow rates of = 30 L/min); OR non-invasive positive pressure ventilation; OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation. |
Through Day 28 |
|
| Secondary |
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14 |
The WHO-8 is an ordinal scale for clinical improvement with scores ranging from 0 to 8, where a lower score indicates better clinical status. A score of 0 represents uninfected; 1 (ambulatory, no limitation of activities); 2 (ambulatory, limitation of activities); 3 (hospitalized with mild disease, no oxygen therapy); 4 (hospitalized with mild disease, oxygen by mask or nasal prongs); 5 (hospitalized with severe disease, non-invasive ventilation or high-flow oxygen); 6 (hospitalized with severe disease, intubation and mechanical ventilation); 7 (hospitalized with severe disease, ventilation and additional organ support [pressors, renal replacement therapy, extracorporeal membrane oxygenation]); and 8 (death). Negative values indicate improvement from baseline. |
At Day 14 |
|
| Secondary |
Median Reduction in Days Spent on Supplemental Oxygen |
Days spent on supplemental oxygen was set as the date of the participant being off of supplemental oxygen minus the date of initiation of supplemental oxygen + 1 day. If a participant received more than 1 period of supplemental oxygen therapy during the study or switched from supplemental oxygen to a more intensive therapy, then the days spent on supplemental oxygen were to be calculated as the sum of all the periods where the participant was on supplemental oxygen or a more intensive therapy through Day 28. If the date of the first initiation of supplemental oxygen was before Baseline Day 1, then the days spent on supplemental oxygen were to be calculated from Baseline Day 1 to the date of the participant being off the supplemental oxygen. Time on supplemental oxygen was to be imputed to the maximum number of days on study drug (28) for all points following the death of a participant. |
Up to Day 28 |
|
| Secondary |
All-Cause Mortality at Study Days 7, 14, 21, and 28 |
The percentage of participants with mortality from any cause was recorded. |
At Study Days 7, 14, 21, and 28 |
|
| Secondary |
Percentage of Participants Experiencing Respiratory Failure or Death on Study Days 7, 14, 21, and 28 |
Respiratory failure is defined as a clinical diagnosis of respiratory failure and initiation of one of the following therapies: endotracheal intubation and mechanical ventilation; OR extracorporeal membrane oxygenation; OR high-flow nasal cannula oxygen delivery (i.e., reinforced nasal cannula delivering heated, humidified oxygen with fraction of delivered oxygen = 0.5 and flow rates of = 30 L/min), OR non-invasive positive pressure ventilation; OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation. |
At Study Days 7, 14, 21, and 28 |
|
| Secondary |
Mechanical Ventilation-Free Survival |
Mechanical ventilation-free survival is defined as the number of days from Baseline Day 1 to the date when a participant initiated mechanical ventilation or died, whichever occurred first, during the 28 days post baseline. If the specified event did not occur by Day 28, participants were to be censored. Specifically, a participant without any post-baseline assessment record was to be censored at Baseline Day 1, a participant who prematurely discontinued from study without a record of death or start of mechanical ventilation was to be censored at the earlier timepoint of the date of study discontinuation or Day 28, an ongoing participant in the study without a record of death or start of mechanical ventilation was to be censored at the earlier timepoint of the date of the last evidence that the participant is not on mechanical ventilation or Day 28. |
Up to Day 28 |
|
| Secondary |
Days on Mechanical Ventilation |
Days spent on mechanical ventilation was defined as the date of the participant being off mechanical ventilation - date of initiation of mechanical ventilation + 1 day. If a participant received more than 1 period of mechanical ventilation during the study or switched from mechanical ventilation to a more intensive therapy, then the days spent on mechanical ventilation were to be calculated as the sum of all the periods where the participant is on mechanical ventilation or a more intensive therapy through Day 28. |
Up to Day 28 |
|
| Secondary |
Median Duration of Hospitalization |
Median duration of hospitalization is defined as the hospitalization discharge date - hospitalization admission date + 1 day. If a participant was hospitalized more than once during the study then the hospitalization time was to be calculated as the sum of all the periods when the participant was hospitalized through Day 28. |
Up to Day 28 |
|
| Secondary |
Time to Discharge From Hospital |
Time to discharge from hospital is defined as the number of days from Baseline Day 1 to the date of the last evidence that a participant is last discharged from hospital, during the 28 days post baseline. If the specified event did not occur by Day 28, participants were censored. Specifically, a participant without any postbaseline assessment record was to be censored at Baseline Day 1, a participant who died was to have time to discharge from hospital censored at Day 28, a participant who prematurely discontinued from study without a record of hospitalization discharge was to be censored at the earlier timepoint of the date of study discontinuation or Day 28, an on-going participant in the study without a record of hospitalization discharge was to be censored at the earlier timepoint of the date of the last evidence that the participant is hospitalized or Day 28. |
Up to Day 28 |
|
| Secondary |
Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio |
The PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2). A PaO2/FiO2 ratio of 300 to 200 is mild, 200 to 100 moderate, and <100 is severe Adult Respiratory Distress Syndrome (ARDS). |
At Study Days 7, 14, 21, and 28 |
|
| Secondary |
Oxygenation Index |
The oxygenation index is used to assess the intensity of ventilatory support required to maintain oxygenation. An index of 0 to < 25 is predictive of a good outcome; 25 to <40 indicates a chance of death >40%; and an index of 40 to 1000 warrants consideration of extracorporeal membrane oxygenation (ECMO). |
At Study Days 7, 14, 21, and 28 |
|
| Secondary |
Number of Participants With Adverse Events |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. |
From first dose of study drug until 30 days following last dose of study drug (up to 70 days) |
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