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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
Last Update Posted : April 22, 2022
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: SOC + IFX-1 Drug: SOC + Placebo Phase 2 Phase 3

Detailed Description:

The phase II and Phase III portions enrolls 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
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 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: SOC + IFX-1 Drug: SOC + IFX-1
SOC + IFX-1
Experimental: Arm B : SOC + Placebo Drug: SOC + Placebo
SOC + Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: Day 28 ]
    28-day all-cause mortality


Secondary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: Day1 to Day 60 ]
    Frequency, severity, and relatedness to study drug of serious and non-serious TEAEs

  2. Safety Parameters [ Time Frame: Day 15, Day 28 ]
    Proportion of patients with an improvement in the 8-point ordinal scale


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

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
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 University Amsterdam
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
Last Update Posted: April 22, 2022
Last Verified: October 2021
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
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases