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Trial record 5 of 10 for:    inflarx
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Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia (PANAMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333420
Recruitment Status : Completed
First Posted : April 3, 2020
Results First Posted : June 5, 2023
Last Update Posted : June 5, 2023
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Study Description
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Brief 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)


Condition or disease Intervention/treatment Phase
Severe COVID-19 Pneumonia Drug: IFX-1 + BSC Drug: BSC Drug: IFX-1 + SOC Drug: Placebo + SOC Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two phases with 2 parallel arms each
Masking: Double (Participant, Investigator)
Masking Description: Phase II: Open label study (30 patients), Phase III: Double- blind (360 patients)
Primary Purpose: Treatment
Official Title: A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase II: IFX-1 + BSC
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
 Drug: IFX-1 + BSC
Phase II study part: IFX-1 + BSC
Other Name: Vilobelimab + Best Supportive Care
Phase II: BSC
Phase II study part: BSC: Best supportive care
 Drug: BSC
Phase II study part: BSC
Other Name: Best Supportive Care
Experimental: Phase III: IFX-1 + SOC
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care
 Drug: IFX-1 + SOC
Phase III study part: IFX-1 + SOC
Other Name: Vilobelimab + Standard of Care
Placebo Comparator: Phase III: Placebo + SOC
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care
 Drug: Placebo + SOC
Phase III study part: Placebo + SOC
Other Name: Placebo + Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) [ Time Frame: 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)

  2. Phase III: 28-day All-cause Mortality (FAS) [ Time Frame: Day 28 ]
    Number and percentage of deaths (all-cause) until Day 28 (FAS)


Secondary Outcome Measures :
  1. Phase II: All-cause 28-day Mortality (FAS) [ Time Frame: Day 28 ]
    Number and percentage of deaths (all-cause) until Day 28 (FAS)

  2. Phase II: Early Response at Day 7 After Enrollment [ Time Frame: Day 7 ]
    Number of patients (%) achieving an early response at day 7 after enrollment (FAS)

  3. Phase II: Late Response Until Day 28 After Enrollment [ Time Frame: Baseline until Day 28 ]
    Number of patients (%) reaching a late response until day 28 (FAS)

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

  5. Phase III: 60-day All-cause Mortality (FAS) [ Time Frame: Day 60 ]
    Number and percentage of deaths (all-cause) until Day 60 (FAS)

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

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

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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months
  • Patient moribund or expected to die in next 24h according to the judgment of the investigator
  • Known severe congestive heart failure (New York Heart Association [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 investigational 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, left ventricular ejection fraction <40%)
  • Known history of chronic liver disease (Child-Pugh B or C)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333420


Locations
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Sponsors and Collaborators
InflaRx GmbH
Investigators
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Principal Investigator: A Vlaar, MD, PhD University Amsterdam
  Study Documents (Full-Text)

Documents provided by InflaRx GmbH:
Study Protocol and Statistical Analysis Plan  [PDF] May 12, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT04333420    
Other Study ID Numbers: IFX-1-P2.9
2020-001335-28 ( EudraCT Number )
First Posted: April 3, 2020    Key Record Dates
Results First Posted: June 5, 2023
Last Update Posted: June 5, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InflaRx GmbH:
COVID-19 related severe pneumonia
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vilobelimab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs