Correlated Drug Terms (2)

---

	Name (Synonyms)	Correlation
drug2799	TAK-671 Placebo Wiki	1.00
drug3177	anti-SARS-CoV-2 convalescent plasma Wiki	0.50

Correlated MeSH Terms (1)

---

	Name (Synonyms)	Correlation
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

---

	Name (Synonyms)	Correlation

Primary Outcomes

Measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

Time: Baseline up to Day 28

---

Measure: Number of Participants With Markedly Abnormal Laboratory Values

Time: Baseline up to Day 28

---

Measure: Number of Participants With Markedly Abnormal Values of Vital Signs

Time: Baseline up to Day 28

---

Measure: Number of Participants With Markedly Abnormal 12-lead Electrocardiograms

Time: Baseline up to Day 28

---

Measure: Number of Participants With Adverse Events (AEs) Related to Physical Examination Findings

Time: Baseline up to Day 28

---

Measure: Ceoi: Serum Concentration at the end of Infusion for TAK-671

Time: Day 14: at the end of infusion (at 336 hours post infusion)

---

Measure: T1/2z: Terminal Disposition Serum Half-life for TAK-671

Time: Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion

---

Measure: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-671

Time: Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion

---

Measure: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-671

Time: Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion

---

Secondary Outcomes

Description: Sustained clinical improvement is defined as a 2-point improvement on the 8-point ordinal scale for clinical improvement, that is at least 2 points increase from the lowest score recorded since randomization and no worsening of the score afterwards by Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).

Measure: Percentage of Participants With Sustained Clinical Improvement or Live Discharge at Day 28

Time: Day 28

---

Description: Sustained clinical recovery is defined as achieving score 6, 7, or 8 based on the ordinal scale and maintained the clinical recovery until Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).

Measure: Percentage of Participants With Sustained Clinical Recovery

Time: Up to 28 days

---

Description: Sustained remission of respiratory symptoms is defined as independence from supplemental oxygen therapy in order to maintain oxygen saturation (SpO2) greater than 94 percent (%) and is maintained up to Day 28.

Measure: Percentage of Participants With Sustained Remission of Respiratory Symptoms

Time: Up to 28 days

---

Measure: Mortality Rate

Time: Up to 28 days

---

Description: Sustained clinical improvement is defined as a 2-point improvement on the 8-point ordinal scale for clinical improvement, that is at least 2 points increase from the lowest score recorded since randomization and no worsening of the score afterwards by Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).

Measure: Time to Sustained Clinical Improvement or Discharge From Hospital

Time: Up to 28 days

---

Description: Sustained clinical recovery is defined as achieving score 6, 7, or 8 based on the ordinal scale and maintained the clinical recovery until Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).

Measure: Time to Sustained Clinical Recovery

Time: Up to 28 days

---

Measure: Percentage of Participants With Any Form of New Ventilation Use

Time: Up to 28 days

---

Measure: Number of Days of New Ventilation Use

Time: Up to 28 days

---

Measure: Number of Ventilation-free Days

Time: Up to 28 days

---

Measure: Number of Days Free of Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)

Time: Up to 28 days

---

Description: Remission of respiratory symptoms is defined as independence from supplemental oxygen therapy in order to maintain SpO2 greater than 94%.

Measure: Time to Sustained Remission of Respiratory Symptoms

Time: Up to 28 days

---

Measure: Percentage of Participants Admitted to Intensive Care Unit (ICU)

Time: Up to 28 days

---

Measure: Number of Days of ICU Stay

Time: Up to 28 days

---

Description: The SOFA score is a scale for describing multiple organ failure in the critical care setting. It is calculated using the functional status of several organ systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and renal. Each of these organ systems is rated on a scale of 1 to 4, based on objective, testable criteria, chiefly laboratory values. The ratings of each of these systems (worse observed value during that 24-hour period) are then summed to create the total score. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.

Measure: Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Days 7, 14, and 28

Time: Baseline, Days 7, 14, and 28

---