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

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ClinicalTrials.gov Identifier: NCT04333420
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : December 7, 2020
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 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
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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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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


Contacts
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Contact: Korinna Pilz, MD +49 89 4141 89 78 ext 0 korinna.pilz@inflarx.de

Locations
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Germany
University of Aachen Recruiting
Aachen, Germany
Contact: Prof. Marx         
Netherlands
University Amsterdam Recruiting
Amsterdam, Netherlands, 1105
Contact: Alexander Vlaar, MD, PhD         
University Amsterdam Recruiting
Amsterdam, Netherlands
Contact: L.M.A Heunks, MD, PhD         
University Maastricht Recruiting
Maastricht, Netherlands
Contact: Pieter van Paassen, MD         
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
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
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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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections