Publication ACTT-4 - Wolfe CR, Lancet Respir Med (2022) (published paper)
Dates: 2020-12-01 to 2021-04-13
Funding: Public/non profit (Gilead Sciences provided remdesivir for use in this trial but did not provide any financial support. Eli Lilly provided baricitinib for use in this trial but did not provide any financial support. Employees of Gilead Sciences and Eli Lilly participated in discussions about protocol development and in weekly protocol team calls. Input from the manufacturer of baricitinib, Eli Lilly, Indianapolis, IN, USA, was considered by the investigators. The National Institute of Allergy and Infectious Diseases (NIAID) ultimately made all decisions regarding trial design and implementation. The trial was sponsored and primarily funded by the NIAID, National Institutes of Health. This trial has also been funded in part by the National Cancer Institute, US Department of Defense, Defense Health Program, the governments of Japan, Mexico, and Singapore, Seoul National University Hospital, and Seoul National University Bundang Hospital.)
Conflict of interest: No
Blinding: triple blinding
Multicenter / USA, South Korea, Mexico, Singapore, Japan |
Follow-up duration (days): 60
Baricitinib - 4 mg once a day orally or by nasogastric tube for up to 14 days ; Remdesivir initial dose 200 mg once intravenously - Maintenance dose 100 mg once a day intravenously for up to 10 days.
Dexamethasone 6 mg once a day intravenously for up to 10 days ; Remdesivir initial dose 200 mg once intravenously - Maintenance dose 100 mg once a day intravenously for up to 10 days.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=1 / Moderate: n=856 / Severe: n=153 Critical: n=0
Number of vaccinated participants: 21
|In the register|
The proportion of subjects not meeting criteria for one of the following two ordinal scale categories at any time: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) [ Time Frame: Day 1 through Day 29 ]
|In the report|
The difference in mechanical ventilation-free survival by day 29.
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The registry primary outcome reflects the reported primary outcome. The trial (n = 1010) did not achieve its target sample size (n = 1382) because a preplanned futility analysis led to early stopping as the DSMB determined that it was unlikely that the study would show a significant difference between the two study groups if the trial continued.|