Participant flow

Adaptive COVID-19 Treatment Trial 2 (ACTT-2) · Source last updated 2022-03-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide. Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

   id

   FG000

   title

   Remdesivir Plus Baricitinib

2. description

   200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course. Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide. Placebo: The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet

   id

   FG001

   title

   Remdesivir Plus Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         36

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         41

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         16

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Became ineligible after enrollment

   6. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         9

      type

      Enrolled but treatment not administered

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Scheduling error

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Transferred to another hospital

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         515

      2. group Id

         FG001

         num Subjects

         518

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         507

      2. group Id

         FG001

         num Subjects

         509

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         431

      2. group Id

         FG001

         num Subjects

         408

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         84

      2. group Id

         FG001

         num Subjects

         110

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 08May2020 and 01Jul2020.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice