適応型COVID-19治療試験4（ACTT-4）

基本情報

NCT ID

NCT04640168

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,010

治験依頼者名

National Institute of Allergy and Infectious Diseases (NIAID)

概要

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)