Trial · NCT04575038
CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19
NCT04575038, Phase 2, Completed, Clear Creek Bio, Inc.; results first posted 2022-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19. Trials, record NCT04575038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04575038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19
- NCT number
- NCT04575038
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 115 participants, actual
- Lead sponsor
- Clear Creek Bio, Inc.
- Conditions
- COVID-19 Infection
- Interventions
- Brequinar, Placebo
- First posted
- 2020-10-05
- Last updated
- 2022-04-19
- Results first posted
- 2022-04-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Log10 SARS-CoV-2 Viral Load | Days 4, 8, 12, 15, 22, and 29 | Median Change from Baseline in Quantitative Log10 SARS-CoV-2 viral load at Days 4, 8, 12, 15, 22, and 29. |
| Secondary | Rates of AEs and SAEs Including Laboratory Assessments | Through Day 29 | Safety measured by number of participants with AEs and SAEs including laboratory assessments. |
| Secondary | Viral Shedding Duration | Through Day 36 | Duration of viral shedding was defined as the time to viral clearance (two consecutive negative test results) for the Microbiology Evaluable Set population. |
| Secondary | Hospital Admission | Day 29 | Percentage of subjects requiring admission as an inpatient for \>24 hours |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Log10 SARS-CoV-2 Viral Load | Days 4, 8, 12, 15, 22, and 29 | Microbiology Evaluable Set (MES) consisted of all randomized subjects with detectable Log10 SARS-CoV-2 viral load at baseline and at least one non-missing postbaseline viral load assessment. Microbiology evaluable subjects were analyzed according to their randomized treatment. SARS-CoV-2 viral load (log 10 copies/mL) was reported as below.~* Number of copies/mL;~* \<Number of copies/mL, if detected but under the lower limit of quantification (LLOQ);~* No SARS-CoV-2 detected, if not detected. | Log 10 SARS-CoV-2 Viral Load Copies/mL | MEDIAN |
| SECONDARY | Rates of AEs and SAEs Including Laboratory Assessments | Through Day 29 | The Safety Analysis Set (Safety) consisted of all subjects who received at least one dose of study drug. Safety analysis subjects were analyzed according to their actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Viral Shedding Duration | Through Day 36 | Microbiology Evaluable Set (MES) consisted of all randomized subjects with detectable Log10 SARS-CoV-2 viral load at baseline and at least one non-missing postbaseline viral load assessment. Microbiology evaluable subjects were analyzed according to their randomized treatment. | Days | MEDIAN |
| SECONDARY | Hospital Admission | Day 29 | Intent-to-treat population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Brequinar 100 mg | Baseline | 5.056 | Full Range 3.14 to 7.96 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Placebo | Baseline | 5.110 | Full Range 3.14 to 8.22 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Brequinar 100 mg | Day 4 Change from Baseline | -1.651 | Full Range -7.94 to 0.87 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Placebo | Day 4 Change from Baseline | -1.881 | Full Range -7.21 to 0.93 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Brequinar 100 mg | Day 8 Change from Baseline | -2.413 | Full Range -7.94 to 1.85 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Placebo | Day 8 Change from Baseline | -3.231 | Full Range -7.78 to 0.12 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Brequinar 100 mg | Day 12 Change from Baseline | -3.907 | Full Range -7.94 to 0.45 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Placebo | Day 12 Change from Baseline | -3.514 | Full Range -7.78 to 0.00 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Brequinar 100 mg | Day 15 Change from Baseline | -4.140 | Full Range -7.94 to 0.20 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
| Log10 SARS-CoV-2 Viral Load | Standard of Care + Placebo | Day 15 Change from Baseline | -3.143 | Full Range -7.78 to 1.40 | Log 10 SARS-CoV-2 Viral Load Copies/mL |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care + Brequinar 100 mg | 56 | |
| Overall Study | STARTED | Standard of Care + Placebo | 59 | |
| Overall Study | COMPLETED | Standard of Care + Brequinar 100 mg | 55 | |
| Overall Study | COMPLETED | Standard of Care + Placebo | 58 | |
| Overall Study | NOT COMPLETED | Standard of Care + Brequinar 100 mg | 1 | |
| Overall Study | NOT COMPLETED | Standard of Care + Placebo | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | Nausea | Gastrointestinal disorders | Standard of Care + Brequinar 100 mg | 2 | 56 | 2 |
| other | Nausea | Gastrointestinal disorders | Standard of Care + Placebo | 2 | 59 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Standard of Care + Brequinar 100 mg | 1 | 56 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Standard of Care + Placebo | 2 | 59 | 2 |
| serious | COVID-19 Pneumonia | Infections and infestations | Standard of Care + Brequinar 100 mg | 1 | 56 | 1 |
| serious | COVID-19 Pneumonia | Infections and infestations | Standard of Care + Placebo | 0 | 59 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care + Brequinar 100 mg | 0 | 56 |
| Total, all-cause mortality | Standard of Care + Placebo | 0 | 59 |
| Total, other adverse events | Standard of Care + Brequinar 100 mg | 3 | 56 |
| Total, other adverse events | Standard of Care + Placebo | 4 | 59 |
| Total, serious adverse events | Standard of Care + Brequinar 100 mg | 1 | 56 |
| Total, serious adverse events | Standard of Care + Placebo | 0 | 59 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard of Care + Brequinar 100 mg vs Standard of Care + Placebo: deaths from any cause | Trial comparisons |
| Standard of Care + Brequinar 100 mg vs Standard of Care + Placebo: Hospital Admission | Trial comparisons |
| Standard of Care + Brequinar 100 mg vs Standard of Care + Placebo: 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/NCT04575038
GET https://conductscience.org/api/trials/v1/NCT04575038/results?page=2