A Pragmatic Adaptive Open Label, Randomized Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

At a glance

Drugs IFX 1 (Primary)
Indications COVID 2019 infections; Pneumonia
Focus Registrational; Therapeutic Use
Acronyms PANAMO
Sponsors InflaRx

Most Recent Events

29 Apr 2020 According to an InflaRx media release, after all patients have been treated in the first part of the trial, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters in order to potentially adapt the confirmatory second part of the study. Part 1 is fully enrolled with 30 patients as of April 24, 2020. Additional centers have been opened in the Netherlands, since March 2020.
08 Apr 2020 New source identified and integrated (European Clinical Trials Database; EudraCT2020-001335-28)
07 Apr 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

Change in PaO2/FiO2

description: Relative change (%) from baseline in Oxygenation Index (PaO2 / FiO2) to day 5.
time_frame: Baseline to Day 5

Other Endpoints

Patients achieving early response

description: Number of patients (%) achieving an Early Response
time_frame: Baseline to Day 7^[1]

Diseases Treated

Indication	Qualifiers	Patient Segments
COVID 2019 infections	treatment	-
Pneumonia	treatment	severe

Subjects

Subject Type patients
Number
Planned: 130
Sex male & female
Age Group ≥ 18 years; adult; elderly

Patient 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).

Patient 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)

Trial Details

Identifiers

Identifier	Owner
NCT04333420	ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001335-28	European Clinical Trials Database
IFX1P2-9	-

Organisations

Sponsors InflaRx
Affiliations InflaRx

Trial Dates

Initiation Dates
Actual : 31 Mar 2020
Primary Completion Dates
Planned : 31 Oct 2020
End Dates
Planned : 31 Dec 2020

Other Details

Design multicentre; open; parallel; prospective; randomised
Phase of Trial Phase II/III
Location Netherlands
Focus Registrational; Therapeutic Use

Drug Name	Highest Phase	Originator
IFX 1	Phase II/III	Beijing Mabworks Biotech, InflaRx

Interventions

Drugs	Route	Formulation
IFX 1Primary Drug	Intravenous	Infusion

Arm A: BSC + IFX-1

Drug: Best supportive Care (BSC) + IFX-1 (Best supportive care [BSC] + IFX-1)

Arm B : BSC only

Drug: Best supportive care only (Best supportive care only)

Trial Centres

Investigators

Download Data (CSV)

Investigator	Centre Name	Trial Centre Country
A Vlaar, MD	University Amsterdam	Netherlands
Alexander Vlaar, MD, PhD	University Amsterdam	Netherlands
Clinical Research and Development Winzerlaer Strasse 2 Jena Postcode: 07745 Germany Telephone: +4989414 1897897 korinna.pilz@inflarx.de show details	InflaRX GmbH	Germany
Korinna Pilz, MD +49 89 4141 89 78 Ext: 0 korinna.pilz@inflarx.de show details	, InflaRx GmbH	-
L.M.A Heunks, MD, PhD	University Amsterdam	Netherlands
Pieter van Paassen, MD	University Maastricht	Netherlands

Centres

Download Data (CSV)

Centre Name	Location	Trial Centre Country
-	-	-
InflaRx GmbH	-	-
InflaRX GmbH	Jena	Germany
University Amsterdam	Amsterdam	Netherlands
University Maastricht	Maastricht	Netherlands

Trial History

Event Date	Event Type	Comment
10 May 2020	Other trial event	Last checked against Eudra record. European Clinical Trials Database Updated 10 May 2020
29 Apr 2020	Other trial event	According to an InflaRx media release, after all patients have been treated in the first part of the trial, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters in order to potentially adapt the confirmatory second part of the study. Part 1 is fully enrolled with 30 patients as of April 24, 2020. Additional centers have been opened in the Netherlands, since March 2020. Updated 04 May 2020
17 Apr 2020	Other trial event	Last checked against the ClinicalTrials.gov record. ClinicalTrials.gov: US National Institutes of Health Updated 17 Apr 2020
08 Apr 2020	Other trial event	New source identified and integrated (European Clinical Trials Database; EudraCT2020-001335-28) European Clinical Trials Database Updated 08 Apr 2020
07 Apr 2020	New trial record	New trial record ClinicalTrials.gov: US National Institutes of Health Updated 07 Apr 2020
31 Mar 2020	Other trial event	According to an InflaRx media release, InflaRx has dosed the first patient this study. Updated 07 Apr 2020

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