Adaptive COVID-19 Treatment Trial (ACTT)
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ClinicalTrials.gov Identifier: NCT04280705 |
Recruitment Status :
Completed
First Posted : February 21, 2020
Results First Posted : September 25, 2020
Last Update Posted : March 14, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
COVID-19 |
Interventions |
Other: Placebo Drug: Remdesivir |
Enrollment | 1062 |
Recruitment Details | Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 21FEB2020 and 20APR2020. |
Pre-assignment Details |
Arm/Group Title | Placebo | Remdesivir |
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Arm/Group Description |
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. Placebo: The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies. |
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 days 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. |
Period Title: Overall Study | ||
Started | 521 | 541 |
Received Treatment | 517 | 531 |
Completed | 508 | 517 |
Not Completed | 13 | 24 |
Reason Not Completed | ||
Enrolled but not treated | 4 | 10 |
Physician Decision | 1 | 0 |
Withdrawal by Subject | 7 | 9 |
Adverse Event | 0 | 4 |
Transferred to another hospital | 1 | 1 |
Arm/Group Title | Placebo | Remdesivir | Total | |
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Arm/Group Description | 200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. | 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 days total course. | Total of all reporting groups | |
Overall Number of Baseline Participants | 521 | 541 | 1062 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 521 participants | 541 participants | 1062 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
324 62.2%
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354 65.4%
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678 63.8%
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>=65 years |
197 37.8%
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187 34.6%
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384 36.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 521 participants | 541 participants | 1062 participants | |
59.2 (15.4) | 58.6 (14.6) | 58.9 (15.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 521 participants | 541 participants | 1062 participants | |
Female |
189 36.3%
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189 34.9%
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378 35.6%
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Male |
332 63.7%
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352 65.1%
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684 64.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 521 participants | 541 participants | 1062 participants | |
Hispanic or Latino |
116 22.3%
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134 24.8%
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250 23.5%
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Not Hispanic or Latino |
373 71.6%
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382 70.6%
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755 71.1%
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Unknown or Not Reported |
32 6.1%
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25 4.6%
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57 5.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 521 participants | 541 participants | 1062 participants | |
American Indian or Alaska Native |
3 0.6%
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4 0.7%
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7 0.7%
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Asian |
56 10.7%
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79 14.6%
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135 12.7%
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Native Hawaiian or Other Pacific Islander |
2 0.4%
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2 0.4%
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4 0.4%
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Black or African American |
117 22.5%
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109 20.1%
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226 21.3%
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White |
287 55.1%
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279 51.6%
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566 53.3%
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More than one race |
1 0.2%
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2 0.4%
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3 0.3%
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Unknown or Not Reported |
55 10.6%
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66 12.2%
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121 11.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 521 participants | 541 participants | 1062 participants |
Greece | 19 | 14 | 33 | |
South Korea | 12 | 9 | 21 | |
Singapore | 7 | 9 | 16 | |
United States | 410 | 427 | 837 | |
Japan | 7 | 8 | 15 | |
Denmark | 21 | 22 | 43 | |
Mexico | 6 | 4 | 10 | |
United Kingdom | 21 | 25 | 46 | |
Germany | 6 | 7 | 13 | |
Spain | 12 | 16 | 28 | |
Disease severity
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 521 participants | 541 participants | 1062 participants |
Mild-to-moderate disease severity |
50 9.6%
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55 10.2%
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105 9.9%
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Severe disease severity |
471 90.4%
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486 89.8%
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957 90.1%
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[1]
Measure Description:
Mild-moderate disease: SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen. Severe disease: requiring mechanical ventilation, requiring oxygen, a SpO2 = 94% on room air, or tachypnea (respiratory rate = 24 breaths/min). |
Name/Title: | John Beigel, MD |
Organization: | Organization:NIAID |
Phone: | 3014519881 |
EMail: | jbeigel@niaid.nih.gov |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT04280705 |
Other Study ID Numbers: |
20-0006 |
First Submitted: | February 20, 2020 |
First Posted: | February 21, 2020 |
Results First Submitted: | September 16, 2020 |
Results First Posted: | September 25, 2020 |
Last Update Posted: | March 14, 2022 |