Trial · NCT04382924
Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
NCT04382924, Phase 2, Phase 3, Completed, Algernon Pharmaceuticals; results first posted 2021-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease. Trials, record NCT04382924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04382924
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
- NCT number
- NCT04382924
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 168 participants, actual
- Lead sponsor
- Algernon Pharmaceuticals
- Conditions
- COVID
- Interventions
- NP-120 (Ifenprodil)
- First posted
- 2020-05-11
- Last updated
- 2021-12-03
- Results first posted
- 2021-12-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Day 15 | 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death |
| Secondary | Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients | Days 1 through 28 | WHO status of subjects at timepoints from baseline to day 28 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death |
| Secondary | NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients | Days 3, 5, 8, 11, 25, 29 | National Early Warning Score assessed between baseline and Day 29 on subjects in 20, 40 mg TID NP-120 arms versus control group The National Early Warning Score (NEWS) scale is a composite of 7 physiological parameters: Respiration Rate (per minute),Oxygen Saturations (%), Any Supplemental Oxygen, Temperature (°C), Systolic BP (mmHg), Heart Rate (per minute), Level of Consciousness. The aggregate results from all 7 physiological parameters are used to obtain the NEW Score., ranging from 0 - 20. Higher values reflect a worse outcome. |
| Secondary | Rate of Mechanical Ventilation in IP Versus Control Group Patients | Up to Day 28 | Rate of mechanical ventilation in 20 and 40 mg TID NP-120 versus control group |
| Secondary | Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients | Up to day 28 | Duration of mechanical ventilation in 20 and 40 mg TID subjects versus control who experience mechanical ventilation |
| Secondary | Duration of Supplemental Oxygen in IP Versus Control Group Patients | Up to Day 29 | Duration in patients only receiving supplemental oxygen in IP versus control group up to Day 29 |
| Secondary | Time to Return to Room Pressure (SpO2 > 94%) on Room Air | Up to Day 29 | Time to return to room pressure (SpO2 \> 94%) on room air in patients in 20, 40 mg TID NP-120 groups versus control group with 94% blood oxygen levels at enrolment Time-to-event endpoints with competing risk were analysed for each dosing group using the Cumulative Incidence Function-CIF (KM) graphical display. Data represents the time (in Days) it took for all participants in the group to return to room pressure air (e.g. the time when the CIF curve hit 100%). |
| Secondary | Duration in ICU (if Applicable) in IP Versus Control Group Patients | Up to Day 29 | Duration of subject in ICU in 20 and 40 TID mg groups versus control group patients |
| Secondary | Rate of Mortality in IP Versus Control Group Patients | Up to Day 29 | Rate of Overall Mortality in 20, 40 mg TID groups versus control group |
| Secondary | Duration of Hospitalization in IP Versus Control Group Patients | Day 15, 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Day 15 | Analysis performed on the number of patients with WHO-7 data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients | Days 1 through 28 | scores on a scale | MEAN | |
| SECONDARY | NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients | Days 3, 5, 8, 11, 25, 29 | NEWS score collected on patients currently hospitalized, or returning for follow up visits | scores on a scale | MEAN |
| SECONDARY | Rate of Mechanical Ventilation in IP Versus Control Group Patients | Up to Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients | Up to day 28 | participants | NUMBER | |
| SECONDARY | Duration of Supplemental Oxygen in IP Versus Control Group Patients | Up to Day 29 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Return to Room Pressure (SpO2 > 94%) on Room Air | Up to Day 29 | Days | NUMBER | |
| SECONDARY | Duration in ICU (if Applicable) in IP Versus Control Group Patients | Up to Day 29 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Mortality in IP Versus Control Group Patients | Up to Day 29 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Hospitalization in IP Versus Control Group Patients | Day 15, 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm A | 1. Not hospitalized no limitations on activities | 10 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm B | 1. Not hospitalized no limitations on activities | 9 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Control Arm | 1. Not hospitalized no limitations on activities | 18 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm A | 2. Not hospitalized but limitations on activities | 7 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm B | 2. Not hospitalized but limitations on activities | 9 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Control Arm | 2. Not hospitalized but limitations on activities | 2 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm A | 3. Hospitalized not requiring supplemental O2 | 13 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm B | 3. Hospitalized not requiring supplemental O2 | 13 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Control Arm | 3. Hospitalized not requiring supplemental O2 | 16 | Participants | |
| Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Treatment Arm A | 4. Hospitalized and requires supplemental O2 | 13 | Participants |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm A | 52 | |
| Overall Study | STARTED | Treatment Arm B | 56 | |
| Overall Study | STARTED | Control Arm | 60 | |
| Overall Study | COMPLETED | Treatment Arm A | 44 | |
| Overall Study | COMPLETED | Treatment Arm B | 46 | |
| Overall Study | COMPLETED | Control Arm | 48 | |
| Overall Study | NOT COMPLETED | Treatment Arm A | 8 | |
| Overall Study | NOT COMPLETED | Treatment Arm B | 10 | |
| Overall Study | NOT COMPLETED | Control Arm | 12 |
Source ClinicalTrials.gov
Adverse events69
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 | Constipation | Gastrointestinal disorders | Treatment Arm A | 2 | 52 | 2 |
| other | Constipation | Gastrointestinal disorders | Treatment Arm B | 3 | 56 | 3 |
| other | Constipation | Gastrointestinal disorders | Control Arm | 3 | 60 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Treatment Arm A | 3 | 52 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Treatment Arm B | 1 | 56 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Control Arm | 3 | 60 | 3 |
| other | Flatulence | Gastrointestinal disorders | Treatment Arm A | 1 | 52 | 1 |
| other | Flatulence | Gastrointestinal disorders | Treatment Arm B | 3 | 56 | 3 |
| other | Flatulence | Gastrointestinal disorders | Control Arm | 1 | 60 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment Arm A | 3 | 52 | 3 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm A | 2 | 52 |
| Total, all-cause mortality | Treatment Arm B | 5 | 56 |
| Total, all-cause mortality | Control Arm | 4 | 60 |
| Total, other adverse events | Treatment Arm A | 36 | 52 |
| Total, other adverse events | Treatment Arm B | 35 | 56 |
| Total, other adverse events | Control Arm | 30 | 60 |
| Total, serious adverse events | Treatment Arm A | 2 | 52 |
| Total, serious adverse events | Treatment Arm B | 6 | 56 |
| Total, serious adverse events | Control Arm | 5 | 60 |
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/NCT04382924
GET https://conductscience.org/api/trials/v1/NCT04382924/results?page=2