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Adaptive COVID-19 Treatment Trial (ACTT)

NCT04280705COMPLETEDChecked 2026-09-21T15:03:31.075Z
11sources
16claims traced
0observed changes
0source conflicts

OVERVIEW

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Brief TitleAdaptive COVID-19 Treatment Trial (ACTT)Primary source2026-09-21T15:03:27.536Z
Official TitleA Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized AdultsPrimary source2026-09-21T15:03:27.536Z
Overall StatusCOMPLETEDPrimary source2026-09-21T15:03:27.536Z
Phase["PHASE3"]Primary source2026-09-21T15:03:27.536Z
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Primary source2026-09-21T15:03:27.536Z
CollaboratorsUNKNOWNPrimary source2026-09-21T15:03:27.536Z
Enrollment1062Primary source2026-09-21T15:03:27.536Z
Enrollment TypeACTUALPrimary source2026-09-21T15:03:27.536Z
Interventions[{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"Remdesivir"}]Primary source2026-09-21T15:03:27.536Z
Conditions["COVID-19"]Primary source2026-09-21T15:03:27.536Z
Primary Outcomes[{"measure":"Time to Recovery","timeFrame":"Day 1 through Day 29"},{"measure":"Time to Recovery by Race","timeFrame":"Day 1 through Day 29"},{"measure":"Time to Recovery by Ethnicity","timeFrame":"Day 1 through Day 29"},{"measure":"Time to Recovery by Sex","timeFrame":"Day 1 through Day 29"}]Primary source2026-09-21T15:03:27.536Z
Secondary Outcomes[{"measure":"Change From Baseline in Alanine Transaminase (ALT)","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Aspartate Transaminase (AST)","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Creatinine","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Glucose","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Hemoglobin","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Platelets","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Prothrombin Time (PT)","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Total Bilirubin","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in White Blood Cell Count (WBC)","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Neutrophils","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Lymphocytes","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Monocytes","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Basophils","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change From Baseline in Eosinophils","timeFrame":"Days 1, 3, 5, 8, 11, 15 and 29"},{"measure":"Change in National Early Warning Score (NEWS) From Baseline","timeFrame":"Days 1, 3, 5, 8, 11, 15, 22, and 29"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1","timeFrame":"Day 1"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3","timeFrame":"Day 3"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5","timeFrame":"Day 5"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8","timeFrame":"Day 8"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11","timeFrame":"Day 11"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15","timeFrame":"Day 15"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22","timeFrame":"Day 22"},{"measure":"Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29","timeFrame":"Day 29"},{"measure":"Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)","timeFrame":"Day 1 through Day 29"},{"measure":"Percentage of Participants Reporting Serious Adverse Events (SAEs)","timeFrame":"Day 1 through Day 29"},{"measure":"Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics","timeFrame":"Day 1 through Day 10"},{"measure":"Duration of Hospitalization","timeFrame":"Day 1 through Day 29"},{"measure":"Duration of New Non-invasive Ventilation or High Flow Oxygen Use","timeFrame":"Day 1 through Day 29"},{"measure":"Duration of New Oxygen Use","timeFrame":"Day 1 through Day 29"},{"measure":"Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use","timeFrame":"Day 1 through Day 29"},{"measure":"Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use","timeFrame":"Day 1 through Day 29"},{"measure":"Percentage of Participants Requiring New Oxygen Use","timeFrame":"Day 1 through Day 29"},{"measure":"Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use","timeFrame":"Day 1 through Day 29"},{"measure":"Mean Change in the Ordinal Scale","timeFrame":"Day 1, 3, 5, 8, 11, 15, 22, and 29"},{"measure":"14-day Participant Mortality","timeFrame":"Day 1 through Day 15"},{"measure":"29-day Participant Mortality","timeFrame":"Day 1 through Day 29"},{"measure":"Time to an Improvement by at Least One Category Using an Ordinal Scale","timeFrame":"Day 1 through Day 29"},{"measure":"Time to an Improvement of at Least Two Categories Using an Ordinal Scale","timeFrame":"Day 1 through Day 29"},{"measure":"Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First","timeFrame":"Day 1 through Day 29"}]Primary source2026-09-21T15:03:27.536Z
Start Date2020-02-21Primary source2026-09-21T15:03:27.536Z
Primary Completion Date2020-05-21Primary source2026-09-21T15:03:27.536Z
Study Completion Date2020-05-21Primary source2026-09-21T15:03:27.536Z
Study TypeINTERVENTIONALPrimary source2026-09-21T15:03:27.536Z

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IntegrityINTEGRITY VERIFIED

Signer identityNOT CHECKED

TimestampLOCAL SIGNED TIME ONLY

Current statusNOT CHECKED

79953862de481af42627d30238a1b84b2f8a936861c8f0c4829601ca0c41233a

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