Trial · NCT04640168
Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
NCT04640168, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2022-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adaptive COVID-19 Treatment Trial 4 (ACTT-4). Trials, record NCT04640168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04640168
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
- NCT number
- NCT04640168
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,010 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- COVID-19
- Interventions
- Baricitinib, Dexamethasone, Placebo, Remdesivir
- First posted
- 2020-11-23
- Last updated
- 2022-06-28
- Results first posted
- 2022-06-28
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Participants 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) | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| Primary | The Proportion of Participants 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) by Race | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| Primary | The Proportion of Participants 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) by Ethnicity | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| Primary | The Proportion of Participants 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) by Sex | Day 1 through Day 29 | Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates. |
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Secondary | Change From Baseline in C-reactive Protein (CRP) | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Secondary | Change From Baseline in Creatinine | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Secondary | Change From Baseline in D-dimer Concentration | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
| Secondary | Change From Baseline in Glucose | Days 1, 3, 5, 8, 11, 15 and 29 | Blood to evaluate glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Participants 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) | Day 1 through Day 29 | The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4. | Proportion of participants | NUMBER |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | Units/Liter (U/L) | MEAN |
| SECONDARY | Change From Baseline in Aspartate Aminotransferase (AST) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | U/L | MEAN |
| SECONDARY | Change From Baseline in C-reactive Protein (CRP) | Days 1, 3, 5, 8, 11, 15 and 29 | The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, the earliest post-treatment dose was used. Participants from sites reporting high sensitivity CRP were excluded. | milligrams/liter (mg/L) | MEAN |
| SECONDARY | Change From Baseline in Creatinine | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in D-dimer Concentration | Days 1, 3, 5, 8, 11, 15 and 29 | The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used. | mg/L fibrinogen-equivalent units (FEU) | MEAN |
| SECONDARY | Change From Baseline in Glucose | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | grams/deciliter (g/dL) | MEAN |
| SECONDARY | Change From Baseline in Platelets | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Prothrombin International Normalized Ratio (INR) | Days 1, 3, 5, 8, 11, 15 and 29 | The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated. | ratio | MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group420
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Proportion of Participants 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) | Remdesivir Plus Baricitinib | 0.87 | 95% Confidence Interval 0.84 to 0.90 | Proportion of participants | |
The Proportion of Participants 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) | Remdesivir Plus Dexamethasone | 0.88 | 95% Confidence Interval 0.84 to 0.90 | Proportion of participants | |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Baricitinib | Day 3 | 1.1 | 95% Confidence Interval -0.9 to 3.1 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Dexamethasone | Day 3 | 4.3 | 95% Confidence Interval 1.2 to 7.4 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Baricitinib | Day 5 | 6.0 | 95% Confidence Interval 0.8 to 11.2 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Dexamethasone | Day 5 | 15.9 | 95% Confidence Interval 11.6 to 20.1 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Baricitinib | Day 8 | 4.7 | 95% Confidence Interval -5.9 to 15.3 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Dexamethasone | Day 8 | 16.1 | 95% Confidence Interval 2.6 to 29.7 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Baricitinib | Day 11 | 5.6 | 95% Confidence Interval -2.0 to 13.2 | Units/Liter (U/L) |
| Change From Baseline in Alanine Aminotransferase (ALT) | Remdesivir Plus Dexamethasone | Day 11 | 15.5 | 95% Confidence Interval 4.1 to 26.9 | Units/Liter (U/L) |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Remdesivir Plus Baricitinib | 516 | |
| Overall Study | STARTED | Remdesivir Plus Dexamethasone | 494 | |
| Overall Study | Treated | Remdesivir Plus Baricitinib | 503 | |
| Overall Study | Treated | Remdesivir Plus Dexamethasone | 482 | |
| Overall Study | ITT and Modified ITT Population | Remdesivir Plus Baricitinib | 516 | |
| Overall Study | ITT and Modified ITT Population | Remdesivir Plus Dexamethasone | 494 | |
| Overall Study | As Treated Population | Remdesivir Plus Baricitinib | 503 | |
| Overall Study | As Treated Population | Remdesivir Plus Dexamethasone | 482 | |
| Overall Study | COMPLETED | Remdesivir Plus Baricitinib | 495 | |
| Overall Study | COMPLETED | Remdesivir Plus Dexamethasone | 475 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphocyte count decreased | Investigations | Remdesivir Plus Baricitinib | 16 | 503 | 17 |
| other | Lymphocyte count decreased | Investigations | Remdesivir Plus Dexamethasone | 34 | 482 | 38 |
| serious | Anaemia | Blood and lymphatic system disorders | Remdesivir Plus Baricitinib | 1 | 503 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Remdesivir Plus Dexamethasone | 1 | 482 | 1 |
| serious | Hypercoagulation | Blood and lymphatic system disorders | Remdesivir Plus Baricitinib | 1 | 503 | 1 |
| serious | Hypercoagulation | Blood and lymphatic system disorders | Remdesivir Plus Dexamethasone | 0 | 482 | 0 |
| serious | Lymphopenia | Blood and lymphatic system disorders | Remdesivir Plus Baricitinib | 2 | 503 | 2 |
| serious | Lymphopenia | Blood and lymphatic system disorders | Remdesivir Plus Dexamethasone | 3 | 482 | 3 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Remdesivir Plus Baricitinib | 0 | 503 | 0 |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Remdesivir Plus Dexamethasone | 1 | 482 | 1 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remdesivir Plus Baricitinib | 28 | 516 |
| Total, all-cause mortality | Remdesivir Plus Dexamethasone | 34 | 494 |
| Total, other adverse events | Remdesivir Plus Baricitinib | 16 | 503 |
| Total, other adverse events | Remdesivir Plus Dexamethasone | 34 | 482 |
| Total, serious adverse events | Remdesivir Plus Baricitinib | 95 | 503 |
| Total, serious adverse events | Remdesivir Plus Dexamethasone | 94 | 482 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Remdesivir Plus Baricitinib vs Remdesivir Plus Dexamethasone: deaths from any cause | Trial comparisons |
| Remdesivir Plus Baricitinib vs Remdesivir Plus Dexamethasone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04640168
GET https://conductscience.org/api/trials/v1/NCT04640168/registered?page=2