ClinicalTrials.gg
Sign In
CompletedNCT04333420PANAMOUpdated Jun 5, 2023Results posted

Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

A Phase 2/3 interventional study of IFX-1 + BSC and BSC in Severe COVID-19 Pneumonia, sponsored by InflaRx GmbH. Completed at 48 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by InflaRx GmbH · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
399
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Phase II \& Phase III:

This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)

Read the detailed description

The phase II and Phase III portions enrolled patients subsequently.

1st patient was enrolled in the phase III portion on 1st October 2020.

02

Conditions studied

  • Severe COVID-19 Pneumonia

Keywords

  • COVID-19 related severe pneumonia
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 399 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Phase II

Inclusion Criteria:

  • At least 18 years of age or older
  • Clinically evident or otherwise confirmed severe pneumonia
  • SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)

Exclusion Criteria:

  • Known history of progressed as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral for > 2 months
  • Patient moribund or expected to die in next 24h according to the judgment of the investigator
  • Known severe congestive heart failure ( [NYHA] Class III- IV)
  • Received organ or bone marrow transplantation in past 3 months
  • Known cardio-pulmonary mechanical resuscitation in past 14 days

Phase III:

Inclusion Criteria:

  • At least 18 years of age or older
  • Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP administration)
  • Patients with a PaO2 / FiO2 ratio of \< 200 and > 60 at randomization (one representative measurement within 6h before randomization)
  • SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)

Exclusion Criteria:

  • Intubated > 48 h at time point of first IMP administration
  • Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator
  • Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization
  • Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months
  • Treatment of COVID-19 with antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health [NIH] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment[s] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)
  • At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.)
  • Received cytokine adsorption therapy in past 3 days
  • Known severe congestive heart failure (corresponding to e.g. NYHA Class III-IV, \<40%)
  • Known history of chronic liver disease ( B or C)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
399 participants (actual)

Study arms

  • Experimental
    Phase II: IFX-1 + BSC

    Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care

    Drug: IFX-1 + BSC

  • Other
    Phase II: BSC

    Phase II study part: BSC: Best supportive care

    Drug: BSC

  • Experimental
    Phase III: IFX-1 + SOC

    Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care

    Drug: IFX-1 + SOC

  • Placebo comparator
    Phase III: Placebo + SOC

    Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care

    Drug: Placebo + SOC

Interventions

  • DrugIFX-1 + BSC

    Phase II study part: IFX-1 + BSC

    Also known as: Vilobelimab + Best Supportive Care

  • DrugBSC

    Phase II study part: BSC

    Also known as: Best Supportive Care

  • DrugIFX-1 + SOC

    Drug page: Vilobelimab

    Phase III study part: IFX-1 + SOC

    Also known as: Vilobelimab + Standard of Care

  • DrugPlacebo + SOC

    Phase III study part: Placebo + SOC

    Also known as: Placebo + Standard of Care

06

What researchers measure

Primary outcomes

  1. Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)

    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)

    Time frame: Baseline and Day 5

  2. Phase III: 28-day All-cause Mortality (FAS)

    Number and percentage of deaths (all-cause) until Day 28 (FAS)

    Time frame: Day 28

Secondary outcomes

  1. Phase II: All-cause 28-day Mortality (FAS)

    Number and percentage of deaths (all-cause) until Day 28 (FAS)

    Time frame: Day 28

  2. Phase II: Early Response at Day 7 After Enrollment

    Number of patients (%) achieving an early response at day 7 after enrollment (FAS)

    Time frame: Day 7

  3. Phase II: Late Response Until Day 28 After Enrollment

    Number of patients (%) reaching a late response until day 28 (FAS)

    Time frame: Baseline until Day 28

  4. Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)

    Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS)

    Time frame: Baseline, Day 3, Day 7, Day 9, Day 11, Day 15

  5. Phase III: 60-day All-cause Mortality (FAS)

    Number and percentage of deaths (all-cause) until Day 60 (FAS)

    Time frame: Day 60

  6. Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)

    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

    Time frame: Day 15, Day 28

  7. Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)

    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)

    Time frame: Day 28

  8. Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)

    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

    Time frame: Day 28

07

Results

Posted Jun 5, 2023

Participant flow

Participant flow — Overall Study
MilestonePhase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOC
Started1515178191
Contributed to full analysis set (fas)1515177191
Contributed to safety analysis set (saf)1515175189
Completed131110393
Not completed247598

Outcome measures

PrimaryPhase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)

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)

Time frame:
Baseline and Day 5
Reported as:
Least squares mean · percentage of change
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)
percentage of changePhase II: IFX-1 + BSCPhase II: BSC
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)15.5 (-11.4 to 42.4)31.9 (6.0 to 57.9)
Statistical analysis
  • Phase II: IFX-1 + BSC vs Phase II: BSC · Linear repeated measures model · p = 0.3677 · Ls means difference: -16.4 · 95% CI -53.2 to 20.3
PrimaryPhase III: 28-day All-cause Mortality (FAS)

Number and percentage of deaths (all-cause) until Day 28 (FAS)

Time frame:
Day 28
Reported as:
Count of participants · Participants
Phase III: 28-day All-cause Mortality (FAS)
ParticipantsPhase III: IFX-1 + SOCPhase III: Placebo + SOC
Dead5477
Alive115105
Missing89
Statistical analysis
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Cox · p = 0.0941 · Hazard ratio (hr): 0.728 · 95% CI 0.502 to 1.056including stratification by site
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Cox · p = 0.0266 · Hazard ratio (hr): 0.674 · 95% CI 0.476 to 0.955Without stratification by site
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Cox · p = 0.0181 · Hazard ratio (hr): 0.648 · 95% CI 0.453 to 0.929Including random effect for site (frailty model)
  • Phase III: IFX-1 + SOC · Regression, Cox · p = 0.0067 · Hazard ratio (hr): 0.613 · 95% CI 0.430 to 0.873Including stratification by country
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Logistic · p = 0.0293 · Risk difference (rd): -11.0 · 95% CI -20.8 to -1.2Risk difference and lower/upper limit of the Confidence Interval are given in percent
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Log Rank · p = 0.0407
SecondaryPhase II: All-cause 28-day Mortality (FAS)

Number and percentage of deaths (all-cause) until Day 28 (FAS)

Time frame:
Day 28
Reported as:
Count of participants · Participants
Phase II: All-cause 28-day Mortality (FAS)
ParticipantsPhase II: IFX-1 + BSCPhase II: BSC
Phase II: All-cause 28-day Mortality (FAS)24
Statistical analysis
  • Phase II: IFX-1 + BSC vs Phase II: BSC · Regression, Cox · p = 0.6494 · Hazard ratio (hr): 0.651 · 95% CI 0.103 to 4.135Covariate: Treatment (IFX-1 + BSC)
SecondaryPhase II: Early Response at Day 7 After Enrollment

Number of patients (%) achieving an early response at day 7 after enrollment (FAS)

Time frame:
Day 7

No measurements were reported for this outcome.

SecondaryPhase II: Late Response Until Day 28 After Enrollment

Number of patients (%) reaching a late response until day 28 (FAS)

Time frame:
Baseline until Day 28

No measurements were reported for this outcome.

SecondaryPhase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)

Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS)

Time frame:
Baseline, Day 3, Day 7, Day 9, Day 11, Day 15
Reported as:
Least squares mean · percentage of change
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
percentage of changePhase II: IFX-1 + BSCPhase II: BSC
Day 37.1 (-10.3 to 24.4)17.6 (0.8 to 34.4)
Day 713.1 (-23.4 to 49.6)36.0 (0.8 to 71.2)
Day 920.7 (-15.5 to 56.9)27.8 (-7.2 to 62.8)
Day 1145.5 (2.1 to 88.9)43.5 (1.7 to 85.4)
Day 1578.5 (19.1 to 138.0)82.6 (25.2 to 140.0)
SecondaryPhase III: 60-day All-cause Mortality (FAS)

Number and percentage of deaths (all-cause) until Day 60 (FAS)

Time frame:
Day 60
Reported as:
Count of participants · Participants
Phase III: 60-day All-cause Mortality (FAS)
ParticipantsPhase III: IFX-1 + SOCPhase III: Placebo + SOC
Dead6287
Alive10293
Missing1311
Statistical analysis
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Cox · p = 0.0815 · Hazard ratio (hr): 0.735 · 95% CI 0.519 to 1.039
SecondaryPhase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)

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

Time frame:
Day 15, Day 28
Reported as:
Count of participants · Participants
Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)
ParticipantsPhase III: IFX-1 + SOCPhase III: Placebo + SOC
Improved8277
Not improved86104
Not evaluable910
Statistical analysis
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Logistic · p = 0.1553 · Risk difference (rd): 7.352 · 95% CI -2.762 to 17.465Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Logistic · p = 0.1181 · Risk difference (rd): 8.078 · 95% CI -1.968 to 18.125Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent
SecondaryPhase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)

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)

Time frame:
Day 28
Reported as:
Count of participants · Participants
Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)
ParticipantsPhase III: IFX-1 + SOCPhase III: Placebo + SOC
Acute kidney failure812
No acute kidney failure158168
Not evaluable1111
Statistical analysis
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Logistic · p = 0.4105 · Risk difference (rd): -2.081 · 95% CI -6.949 to 2.787Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent
SecondaryPhase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)

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

Time frame:
Day 28
Reported as:
Count of participants · Participants
Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)
ParticipantsPhase III: IFX-1 + SOCPhase III: Placebo + SOC
Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)160161
Statistical analysis
  • Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC · Regression, Cox · p = 0.0422 (p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.) · Hazard ratio (hr): 0.539 · 95% CI 0.297 to 0.978Covariate: Treatment (IFX-1 + SOC)

Adverse events

Collected over Phase II study part: 4 weeks; Phase III study part: 60 days;. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase II: IFX-1 + BSC2/15 (13.3%)9/15 (60%)14/15 (93.3%)
Phase II: BSC4/15 (26.7%)7/15 (46.7%)14/15 (93.3%)
Phase III: IFX-1 + SOC62/175 (35.4%)103/175 (58.9%)147/175 (84%)
Phase III: Placebo + SOC86/189 (45.5%)122/189 (64.6%)154/189 (81.5%)
Phase III: Randomized Non-treated Patients1/5 (20%)2/5 (40%)0/5 (0%)
Most frequent serious events
Showing 10 of 208
Most frequent serious events
EventPhase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCPhase III: Randomized Non-treated Patients
Pulmonary embolismRespiratory, thoracic and mediastinal disorders2/156/1512/17514/1890/5
Multiple organ dysfunction syndromeGeneral disorders0/154/1516/17521/1890/5
PneumoniaInfections and infestations1/153/1521/17516/1890/5
Cardiac failure acuteCardiac disorders0/150/151/1750/1891/5
Hypertensive emergencyVascular disorders0/150/150/1750/1891/5
Acute kidney injuryRenal and urinary disorders0/151/1516/17531/1890/5
Septic shockInfections and infestations0/150/1524/17530/1890/5
Respiratory failureRespiratory, thoracic and mediastinal disorders2/151/1520/17524/1890/5
HypoxiaRespiratory, thoracic and mediastinal disorders2/150/155/1753/1890/5
DeliriumPsychiatric disorders2/150/150/1750/1890/5
Most frequent other events
Showing 10 of 129
Most frequent other events
EventPhase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCPhase III: Randomized Non-treated Patients
Impaired gastric emptyingGastrointestinal disorders4/157/154/1753/1890/5
Decubitus ulcerSkin and subcutaneous tissue disorders4/156/154/1755/1890/5
HypernatraemiaMetabolism and nutrition disorders4/155/1511/17513/1890/5
HypophosphataemiaMetabolism and nutrition disorders4/155/152/1758/1890/5
HypokalaemiaMetabolism and nutrition disorders4/154/157/1758/1890/5
HyperglycaemiaMetabolism and nutrition disorders4/153/156/17511/1890/5
DeliriumPsychiatric disorders3/154/1514/17513/1890/5
Oedema peripheralGeneral disorders0/154/1510/1759/1890/5
ConstipationGastrointestinal disorders2/154/156/1753/1890/5
Pulmonary embolismRespiratory, thoracic and mediastinal disorders4/151/1510/1756/1890/5

Baseline characteristics

Full Analysis Set (excluding one subject who was randomized in error to group Phase III: IFX-1 + SOC)

Age, Continuous
Age, Continuous(years)Phase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCTotal
Mean57.5 ± 8.662.8 ± 8.156.7 ± 13.255.9 ± 14.556.6 ± 13.6
Sex: Female, Male
Sex: Female, Male(Participants)Phase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCTotal
Female445264124
Male1111125127274
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Phase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCTotal
Race — White811115119253
Race — Asian524516
Race — Black or African American225817
Race — American Indian or Alaskan Native00222446
Race — Native Hawaiian or other Pacific Islander00000
Race — Multiple00101
Race — Other00161935
Race — Not reported00141630
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Phase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCTotal
Ethnicity — Hispanic or Latino006068128
Ethnicity — Not Hispanic or Latino15157073173
Ethnicity — Not Reported00283563
Ethnicity — Unknown00111122
Ethnicity — Missing008412
Intubation status
Intubation status(Participants)Phase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCTotal
No750012
Yes810177191386
Oxygenation index
Oxygenation index(index)Phase II: IFX-1 + BSCPhase II: BSCPhase III: IFX-1 + SOCPhase III: Placebo + SOCTotal
Mean137.9 ± 51.1144.2 ± 41.5131.9 ± 39.2130.6 ± 44.8131.9 ± 42.5
08

Study locations

48 sites
  • InflaRx Site #1107
    Aalst, Belgium
  • InflaRx Site #1102
    Brussels, Belgium
  • InflaRx Site #1104
    Leuven, Belgium
  • InflaRx Site #1106
    Lodelinsart, Belgium
  • InflaRx Site #1101
    Yvoir, Belgium
  • InflaRx Site #0301
    Belo Horizonte, Brazil
  • InflaRx Site #0302
    Campinas, Brazil
  • InflaRx Site #0305
    Criciúma, Brazil
  • InflaRx Site #0308
    Curitiba, Brazil
  • InflaRx Site #0304
    Porto Alegre, Brazil
  • InflaRx Site #0303
    São José, Brazil
  • InflaRx Site #0306
    São Paulo, Brazil
  • InflaRx Site #1011
    Grenoble, France
  • InflaRx Site #1005
    Nantes, France
  • InflaRx Site #1009
    Nantes, France
  • InflaRx Site #1003
    Nice, France
  • InflaRx Site #1001
    Paris, France
  • InflaRx Site #1004
    Paris, France
  • InflaRx Site #1006
    Paris, France
  • InflaRx Site #1008
    Paris, France
  • InflaRx Site #1012
    Saint-Étienne, France
  • InflaRx Site #1002
    Suresnes, France
  • InflaRx Site #0201
    Aachen, Germany
  • InflaRx Site #0207
    Augsburg, Germany
  • InflaRx Site #0202
    Berlin, Germany
  • InflaRx Site #0208
    Dresden, Germany
  • InflaRx Site #0204
    Essen, Germany
  • InflaRx Site #0203
    Greifswald, Germany
  • InflaRx Site #0205
    Hannover, Germany
  • InflaRx Site #0206
    Jena, Germany
  • InflaRx Site #0502
    Chihuahua, Mexico
  • InflaRx Site #0503
    Culiacán, Mexico
  • InflaRx Site #0504
    Monterrey, Mexico
  • InflaRx Site #0506
    Mérida, Mexico
  • InflaRx Site #0501
    Nuevo León, Mexico
  • InflaRx Site #0505
    Veracruz, Mexico
  • InflaRx Site #0101
    Amsterdam, Netherlands
  • InflaRx Site #0103
    Amsterdam, Netherlands
  • InflaRx Site #0106
    Eindhoven, Netherlands
  • InflaRx Site #0104
    Enschede, Netherlands
  • InflaRx Site #0102
    Maastricht, Netherlands
  • InflaRx Site #0601
    Callao, Peru
  • InflaRx Site #0603
    Lima, Peru
  • InflaRx Site #0604
    Lima, Peru
  • InflaRx Site #0701
    Barnaul, Russian Federation
  • InflaRx Site #0704
    Moscow, Russian Federation
  • InflaRx Site #0702
    Ryazan', Russian Federation
  • InflaRx Site # 0804
    Somerset West, South Africa
09

References and documents

Publications

  • Vlaar APJ, Witzenrath M, van Paassen P, Heunks LMA, Mourvillier B, de Bruin S, Lim EHT, Brouwer MC, Tuinman PR, Saraiva JFK, Marx G, Lobo SM, Boldo R, Simon-Campos JA, Cornet AD, Grebenyuk A, Engelbrecht JM, Mukansi M, Jorens PG, Zerbib R, Ruckinger S, Pilz K, Guo R, van de Beek D, Riedemann NC; PANAMO study group. Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Dec;10(12):1137-1146. doi: 10.1016/S2213-2600(22)00297-1. Epub 2022 Sep 7. PubMed 36087611 ↗
  • Vlaar APJ, Lim EHT, de Bruin S, Ruckinger S, Pilz K, Brouwer MC, Guo RF, Heunks LMA, Busch MH, van Paassen P, Riedemann NC, van de Beek D. The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19. Clin Transl Sci. 2022 Apr;15(4):854-858. doi: 10.1111/cts.13213. Epub 2022 Jan 14. PubMed 35029045 ↗
  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. PubMed 34473343 ↗
  • Vlaar APJ, de Bruin S, Busch M, Timmermans SAMEG, van Zeggeren IE, Koning R, Ter Horst L, Bulle EB, van Baarle FEHP, van de Poll MCG, Kemper EM, van der Horst ICC, Schultz MJ, Horn J, Paulus F, Bos LD, Wiersinga WJ, Witzenrath M, Rueckinger S, Pilz K, Brouwer MC, Guo RF, Heunks L, van Paassen P, Riedemann NC, van de Beek D. Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. Lancet Rheumatol. 2020 Dec;2(12):e764-e773. doi: 10.1016/S2665-9913(20)30341-6. Epub 2020 Sep 28. PubMed 33015643 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04333420
Lead sponsor
InflaRx GmbH
Responsible party
Sponsor
First posted
Apr 3, 2020
Start date
Mar 31, 2020
Primary completion
Oct 31, 2021
Completion
Dec 1, 2021
Results posted
Jun 5, 2023
Last update
Jun 5, 2023

Study contacts

A Vlaar, MD, PhD
principal investigator · University Amsterdam

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Vilobelimab

Other studies in this condition

COVID-19 →

Other studies from this sponsor

InflaRx GmbH

Start the discussion