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:
- evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by clinical severity, hospitalization, and mortality,
- 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.
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
ACTT1
The trial compared daily investigational treatment of remdesivir delivered intravenously to a placebo control. Remdesivir is an investigational broad-spectrum antiviral treatment developed by Gilead Sciences Inc. Enrollment for ACTT-1 began on February 21, 2020 and ended on April 19, 2020. A total of 1063 patients across 73 sites underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group.
Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.
Find our more abour the study results here.
ACTT2
The clinical trial is the next iteration of Adaptive COVID-19 Treatment Trial (ACTT), called ACTT 2. It will evaluate the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19).
The trial is expected to open at approximately 100 sites around the word and investigators aim to enroll more than 1,000 participants. In this next trial all participants will receive remdesivir or remdesivir with baricitinib. Baricitinib, a product licensed to Eli Lilly and Company by Incyte and marketed under the brand name Olumiant, is approved in the U.S. and in more than 65 additional countries as a treatment for adults with moderately to severely active rheumatoid arthritis.
Participants in the trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation. Individuals with confirmed infection who have mild symptoms, or no apparent symptoms, will not be included in the study. Eligible study participants will be randomly assigned 1:1 to a treatment arm:
Arm 1: participants receive baricitinib tablets orally and intravenous (IV) remdesivir.
Arm 2: participants receive placebo tablets orally and IV remdesivir.