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TAK-671Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug2412 TAK-671 Placebo Wiki 1.00
drug2974 questionaire to husband and wife Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Randomized, Double-blind, Placebo-Controlled Multicenter Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 2 Different Intravenous Doses of TAK-671 for the Treatment of Coronavirus Disease 2019 in Adults

The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.

NCT04464460 Coronavirus Disease Drug: TAK-671 Drug: TAK-671 Placebo
MeSH:Coronavirus Infections

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


No related HPO nodes (Using clinical trials)