Trial · NCT04750278
A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
NCT04750278, Phase 2, Phase 3, Terminated, Foresee Pharmaceuticals Co., Ltd.; results first posted 2024-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19. Trials, record NCT04750278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04750278
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
- NCT number
- NCT04750278
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Conditions
- Severe to Critical COVID 19 With Associated ARDS
- Interventions
- FP-025 100 mg, FP-025 300 mg, Placebo
- First posted
- 2021-02-11
- Last updated
- 2024-01-05
- Results first posted
- 2024-01-05
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | Day 28 | Percentage of patients alive and not requiring non-invasive or invasive ventilation at Day 28 |
| Secondary | Percentage of Patients on Invasive Mechanical Ventilation | Day 28 | Percentage of patients on invasive mechanical ventilation at Day 28 |
| Secondary | Percentage of Patients Alive | Day 28 | Percentage of patients who are alive at the time of the assessment, day 28. |
| Secondary | Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | Day 60 | (ie, not receiving high flow nasal cannula, non-invasive positive pressure ventilation, invasive mechanical ventilation, or ECMO) |
| Secondary | Percentage of Patients on Invasive Mechanical Ventilation | Day 60 | Percentage of patients receiving high flow nasal cannula, non-invasive positive pressure ventilation, invasive mechanical ventilation, or ECMO at day 60 |
| Secondary | Percentage of Patients Alive | Day 60 | Percentage of patients who continue to be alive at day 60. |
| Other | Quantitative Assessment of Lung Fibrosis | Day 28 and Day 60 | Percentage of patients having lung fibrosis using high resolution, non-contrast CT scan, at days 28 and 60 |
| Other | Percentage of Patients Who Were Randomized on Invasive Mechanical Ventilation Who Are Free of Invasive Mechanical Ventilation | Day 28 and at Day 60 | Percentage of patients at days 28 and 60 who improved to breathing on their own, after having been on mechanical ventilation at some point during their treatment. |
| Other | Number of Ventilator Free Days (ie, Days Free of Invasive Mechanical Ventilation) | Day 28 and Day 60 | Number of days (out of 28 and 60, respectively) that patient is off of mechanical ventilation. |
| Other | Number of ICU Free Days | Day 28 and Day 60 | Number of days (out of 28 and 60, respectively) that the patient is not in the ICU |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients on Invasive Mechanical Ventilation | Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Alive | Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients on Invasive Mechanical Ventilation | Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Alive | Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Quantitative Assessment of Lung Fibrosis | Day 28 and Day 60 | |||
| OTHER_PRE_SPECIFIED | Percentage of Patients Who Were Randomized on Invasive Mechanical Ventilation Who Are Free of Invasive Mechanical Ventilation | Day 28 and at Day 60 | |||
| OTHER_PRE_SPECIFIED | Number of Ventilator Free Days (ie, Days Free of Invasive Mechanical Ventilation) | Day 28 and Day 60 | |||
| OTHER_PRE_SPECIFIED | Number of ICU Free Days | Day 28 and Day 60 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | FP-025 300 mg | Meeting the primary efficacy endpoint | 15 | Participants | |
| The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | FP-025 100 mg | Meeting the primary efficacy endpoint | 10 | Participants | |
| The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | Placebo | Meeting the primary efficacy endpoint | 18 | Participants | |
| The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | FP-025 300 mg | Not meeting the primary efficacy endpoint | 15 | Participants | |
| The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | FP-025 100 mg | Not meeting the primary efficacy endpoint | 19 | Participants | |
| The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation | Placebo | Not meeting the primary efficacy endpoint | 13 | Participants | |
| Percentage of Patients on Invasive Mechanical Ventilation | FP-025 300 mg | Percentage of patients on invasive mechanical ventilation at Day 28 | 10 | Participants | |
| Percentage of Patients on Invasive Mechanical Ventilation | FP-025 100 mg | Percentage of patients on invasive mechanical ventilation at Day 28 | 14 | Participants | |
| Percentage of Patients on Invasive Mechanical Ventilation | Placebo | Percentage of patients on invasive mechanical ventilation at Day 28 | 11 | Participants | |
| Percentage of Patients on Invasive Mechanical Ventilation | FP-025 300 mg | Percentage of patients not on invasive mechanical ventilation at Day 28 | 20 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FP-025 300 mg | 30 | |
| Overall Study | STARTED | FP-025 100 mg | 29 | |
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | Completed D28 Visit | FP-025 300 mg | 16 | |
| Overall Study | Completed D28 Visit | FP-025 100 mg | 16 | |
| Overall Study | Completed D28 Visit | Placebo | 18 | |
| Overall Study | COMPLETED | FP-025 300 mg | 15 | |
| Overall Study | COMPLETED | FP-025 100 mg | 13 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | FP-025 300 mg | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events51
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 | Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | FP-025 300 mg | 8 | 30 | 8 |
| other | Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | FP-025 100 mg | 7 | 28 | 10 |
| other | Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Placebo | 5 | 30 | 5 |
| other | Infections and infestations | Infections and infestations | FP-025 300 mg | 5 | 30 | 6 |
| other | Infections and infestations | Infections and infestations | FP-025 100 mg | 7 | 28 | 13 |
| other | Infections and infestations | Infections and infestations | Placebo | 7 | 30 | 9 |
| other | Cardiac disorders | Cardiac disorders | FP-025 300 mg | 5 | 30 | 6 |
| other | Cardiac disorders | Cardiac disorders | FP-025 100 mg | 6 | 28 | 9 |
| other | Cardiac disorders | Cardiac disorders | Placebo | 5 | 30 | 9 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | FP-025 300 mg | 5 | 30 | 8 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FP-025 300 mg | 9 | 30 |
| Total, all-cause mortality | FP-025 100 mg | 10 | 29 |
| Total, all-cause mortality | Placebo | 10 | 31 |
| Total, other adverse events | FP-025 300 mg | 17 | 30 |
| Total, other adverse events | FP-025 100 mg | 21 | 28 |
| Total, other adverse events | Placebo | 19 | 30 |
| Total, serious adverse events | FP-025 300 mg | 11 | 30 |
| Total, serious adverse events | FP-025 100 mg | 12 | 28 |
| Total, serious adverse events | Placebo | 11 | 30 |
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 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/NCT04750278
GET https://conductscience.org/api/trials/v1/NCT04750278/registered?page=2