Trial · NCT04333420
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
NCT04333420, Phase 2, Phase 3, Completed, InflaRx GmbH; results first posted 2023-06-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia. Trials, record NCT04333420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04333420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
- NCT number
- NCT04333420
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 399 participants, actual
- Lead sponsor
- InflaRx GmbH
- Conditions
- Severe COVID-19 Pneumonia
- Interventions
- IFX-1 + BSC, BSC, IFX-1 + SOC, Placebo + SOC
- First posted
- 2020-04-03
- Last updated
- 2023-06-05
- Other registries' IDs
- eudract:2020-001335-28
- Results first posted
- 2023-06-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) | Baseline and Day 5 | Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS) |
| Primary | Phase III: 28-day All-cause Mortality (FAS) | Day 28 | Number and percentage of deaths (all-cause) until Day 28 (FAS) |
| Secondary | Phase II: All-cause 28-day Mortality (FAS) | Day 28 | Number and percentage of deaths (all-cause) until Day 28 (FAS) |
| Secondary | Phase II: Early Response at Day 7 After Enrollment | Day 7 | Number of patients (%) achieving an early response at day 7 after enrollment (FAS) |
| Secondary | Phase II: Late Response Until Day 28 After Enrollment | Baseline until Day 28 | Number of patients (%) reaching a late response until day 28 (FAS) |
| Secondary | Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS) | Baseline, Day 3, Day 7, Day 9, Day 11, Day 15 | Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS) |
| Secondary | Phase III: 60-day All-cause Mortality (FAS) | Day 60 | Number and percentage of deaths (all-cause) until Day 60 (FAS) |
| Secondary | Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS) | Day 15, Day 28 | Percentage of patients with an improvement in the 8-point ordinal scale (Day 15, Day 28), the scale ranges from 0 = 'No clinical or virological evidence of infection' to 8 = 'Death' with higher scores meaning greater limitation and ventilation/organ support |
| Secondary | Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS) | Day 28 | Percentage of patients developing acute kidney failure (estimated glomerular filtration rate \[eGFR\] \< 15 mL/min/1.73m², assessed by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation requiring race information) until Day 28 (FAS) |
| Secondary | Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS) | Day 28 | Percentage of patients free of any renal replacement therapy (RRT) within 28 days upon randomization (FAS), number of patients free of any RRT = number of patients - number of patients with RRT initiated after randomization until Day 28 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) | Baseline and Day 5 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle. | percentage of change | LEAST_SQUARES_MEAN |
| PRIMARY | Phase III: 28-day All-cause Mortality (FAS) | Day 28 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase II: All-cause 28-day Mortality (FAS) | Day 28 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase II: Early Response at Day 7 After Enrollment | Day 7 | The analysis of early response as planned in the protocol was not performed because the necessary data were not collected. | ||
| SECONDARY | Phase II: Late Response Until Day 28 After Enrollment | Baseline until Day 28 | The analysis of late response as planned in the protocol was not performed because the necessary data were not collected. | ||
| SECONDARY | Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS) | Baseline, Day 3, Day 7, Day 9, Day 11, Day 15 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Phase III: 60-day All-cause Mortality (FAS) | Day 60 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS) | Day 15, Day 28 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS) | Day 28 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS) | Day 28 | Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) | Phase II: IFX-1 + BSC | 15.5 | 95% Confidence Interval -11.4 to 42.4 | percentage of change | |
| Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) | Phase II: BSC | 31.9 | 95% Confidence Interval 6.0 to 57.9 | percentage of change | |
| Phase III: 28-day All-cause Mortality (FAS) | Phase III: IFX-1 + SOC | Dead | 54 | Participants | |
| Phase III: 28-day All-cause Mortality (FAS) | Phase III: Placebo + SOC | Dead | 77 | Participants | |
| Phase III: 28-day All-cause Mortality (FAS) | Phase III: IFX-1 + SOC | Alive | 115 | Participants | |
| Phase III: 28-day All-cause Mortality (FAS) | Phase III: Placebo + SOC | Alive | 105 | Participants | |
| Phase III: 28-day All-cause Mortality (FAS) | Phase III: IFX-1 + SOC | Missing | 8 | Participants | |
| Phase III: 28-day All-cause Mortality (FAS) | Phase III: Placebo + SOC | Missing | 9 | Participants | |
| Phase II: All-cause 28-day Mortality (FAS) | Phase II: IFX-1 + BSC | 2 | Participants | ||
| Phase II: All-cause 28-day Mortality (FAS) | Phase II: BSC | 4 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase II: IFX-1 + BSC | 15 | |
| Overall Study | STARTED | Phase II: BSC | 15 | |
| Overall Study | STARTED | Phase III: IFX-1 + SOC | 178 | |
| Overall Study | STARTED | Phase III: Placebo + SOC | 191 | |
| Overall Study | Contributed to Full Analysis Set (FAS) | Phase II: IFX-1 + BSC | 15 | |
| Overall Study | Contributed to Full Analysis Set (FAS) | Phase II: BSC | 15 | |
| Overall Study | Contributed to Full Analysis Set (FAS) | Phase III: IFX-1 + SOC | 177 | |
| Overall Study | Contributed to Full Analysis Set (FAS) | Phase III: Placebo + SOC | 191 | |
| Overall Study | Contributed to Safety Analysis Set (SAF) | Phase II: IFX-1 + BSC | 15 | |
| Overall Study | Contributed to Safety Analysis Set (SAF) | Phase II: BSC | 15 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,685
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 | Pneumonia | Infections and infestations | Phase II: IFX-1 + BSC | 1 | 15 | 1 |
| other | Pneumonia | Infections and infestations | Phase II: BSC | 2 | 15 | 2 |
| other | Pneumonia | Infections and infestations | Phase III: IFX-1 + SOC | 22 | 175 | 27 |
| other | Pneumonia | Infections and infestations | Phase III: Placebo + SOC | 12 | 189 | 16 |
| other | Pneumonia | Infections and infestations | Phase III: Randomized Non-treated Patients | 0 | 5 | 0 |
| other | Aspergillus infection | Infections and infestations | Phase II: IFX-1 + BSC | 1 | 15 | 1 |
| other | Aspergillus infection | Infections and infestations | Phase II: BSC | 0 | 15 | 0 |
| other | Aspergillus infection | Infections and infestations | Phase III: IFX-1 + SOC | 1 | 175 | 1 |
| other | Aspergillus infection | Infections and infestations | Phase III: Placebo + SOC | 0 | 189 | 0 |
| other | Aspergillus infection | Infections and infestations | Phase III: Randomized Non-treated Patients | 0 | 5 | 0 |
1 to 10 of 1,685Source ClinicalTrials.gov
See all 1,685 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II: IFX-1 + BSC | 2 | 15 |
| Total, all-cause mortality | Phase II: BSC | 4 | 15 |
| Total, all-cause mortality | Phase III: IFX-1 + SOC | 62 | 175 |
| Total, all-cause mortality | Phase III: Placebo + SOC | 86 | 189 |
| Total, all-cause mortality | Phase III: Randomized Non-treated Patients | 1 | 5 |
| Total, other adverse events | Phase II: IFX-1 + BSC | 14 | 15 |
| Total, other adverse events | Phase II: BSC | 14 | 15 |
| Total, other adverse events | Phase III: IFX-1 + SOC | 147 | 175 |
| Total, other adverse events | Phase III: Placebo + SOC | 154 | 189 |
| Total, other adverse events | Phase III: Randomized Non-treated Patients | 0 | 5 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
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 |
|---|---|
| Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC: Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS) | Trial comparisons |
| Phase II: IFX-1 + BSC vs Phase II: BSC: Phase II: All-cause 28-day Mortality (FAS) | 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/NCT04333420
GET https://conductscience.org/api/trials/v1/NCT04333420/results?page=2