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Adaptive COVID-19 Treatment Trial (ACTT)

The Adaptive COVID-19 Treatment Trial (ACTT) study is a randomized, controlled clinical trial to evaluate the safety and clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19.  The secondary objectives of the study are to:

  1. evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by clinical severity, hospitalization, and mortality,
  2. evaluate the safety of different investigational therapeutics as compared to the control arm.
The study is a multicenter trial that will be conducted in up to approximately 75 sites globally and coordinated by INSIGHT research network. This study is an adaptive, randomized, double-blind, placebo-controlled trial.

The trial compares daily investigational treatment of remdesivir delivered intravenously to a placebo control. Remdesivir is an investigational broad-spectrum antiviral treatment developed by Gilead Sciences Inc.

There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. Study participants will be assessed daily while hospitalized. Discharged participants will be asked to attend study visits at Days 15 and 29. All participants will undergo a series of efficacy, safety, and laboratory assessments.

The study has received support from the Ministry of Higher Education and Science of Denmark to investigate treatment options of patients hospitalised with COVID-19 in Europe.
 

For more information about the ACTT Study, please contact Dorthe Raben dorthe.raben@regionh.dk