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Open-label, Randomized 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333420
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Brief Summary:
This is a pragmatic, adaptive, open-label, randomized, multicenter phase II/III study consisting of two parts: Phase II and Phase III. In both study parts, patients will be randomized to two treatment arms (Arm A: best supportive care [BSC] + IFX-1; Arm B: BSC alone). After all patients are treated in Phase II, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Best supportive Care (BSC) + IFX-1 Drug: Best supportive care only Phase 2 Phase 3

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Study Type : Interventional
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic Adaptive Open Label, Randomized 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 : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Arm A: BSC + IFX-1 Drug: Best supportive Care (BSC) + IFX-1
Best supportive care [BSC] + IFX-1

Experimental: Arm B : BSC only Drug: Best supportive care only
Best supportive care only




Primary Outcome Measures :
  1. Change in PaO2/FiO2 [ Time Frame: Baseline to Day 5 ]
    Relative change (%) from baseline in Oxygenation Index (PaO2 / FiO2) to day 5.


Secondary Outcome Measures :
  1. Patients achieving early response [ Time Frame: Baseline to Day 7 ]
    Number of patients (%) achieving an Early Response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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-CoV2 infection confirmation (tested positive in last 14 days or test results to be obtained within 24h after enrollment, both with locally available test system).

Exclusion Criteria:

  • Known history of COPD
  • Received new other biologic treatment attempt for COVID-19 in the past 14 days
  • Received treatment with a viral replication inhibitor in past 3 days
  • Received organ or bone marrow transplantation in past 3 months
  • Known mechanically resuscitation in past 14 days
  • Known severe congestive heart failure (NYHA-Class III - IV)

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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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
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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: April 16, 2020
Last Verified: April 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