Trial · NCT04803227
Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19
NCT04803227, Phase 1, Terminated, Histogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19. Trials, record NCT04803227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04803227
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19
- NCT number
- NCT04803227
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Histogen
- Conditions
- Covid19
- Interventions
- Emricasan, Placebo
- First posted
- 2021-03-17
- Last updated
- 2022-01-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 14 Days | Incidence rate of related treatment-emergent adverse events |
| Secondary | Patient reported outcomes as assessed by COVID-19 assessment tool | At screening/randomization, daily televisits (Day 2 - Day 13), Day 14, Day 30 and Day 45 | The 2020 FDA Guidance for Industry Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment is the PRO that will be used for the study. |
| Secondary | Number of participants that experience death during the study. | 45 Days | Rate of mortality events |
| Secondary | Number of participants the experience a related serious adverse event as assessed by CTCAE v5.0. | 45 Days | Cumulative incidence rate of related serious adverse events |
| Secondary | Number of participants that experiences a Grade 3 and 4 adverse event as assessed by CTCAE v5.0 | 45 Days | Cumulative incidence rate of Grade 3 and 4 adverse events |
| Secondary | Number of participants with a discontinuation or temporary suspension of study drug | 45 days | Each participant that discontinues or temporarily suspends study drug for any reason. |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Day 1, Day 14, Day 30 and Day 45 | Each participant will be assessed via performance of standard of care hematology and biochemistry labs. The results of the labs will be assessed against a set of normal ranges for the CLIA certified laboratory. |
| Secondary | Each participant will be tested for SARS-CoV-2 viral eradication via a sample from the nasopharynx and the sample will be tested via RT- PCR. | Days 14, 30 and 45 | SARS-CoV-2 viral eradication from nasopharynx at end of treatment. |
| Secondary | Each participant will perform a 6 minute walk test (6MWD) for distance (400-700m) walked. | Days 14, 30 and 45 | Perform 6 Minute Walk Test |
| Secondary | Each participant will be assessed for COVID-19 severity via an 8-point ordinal scale | Days 14, 30 and 45 | COVID-19 severity score on the 8-point COVID-19 Severity Scale. Scores are from 1 to 8, where 1 = uninfected and 8 = death |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04803227
GET https://conductscience.org/api/trials/v1/NCT04803227/registered