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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 : Completed
First Posted : April 3, 2020
Last Update Posted : April 22, 2022
Information provided by (Responsible Party):
InflaRx GmbH

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 3, 2020
Last Update Posted Date April 22, 2022
Actual Study Start Date  ICMJE March 31, 2020
Actual Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
Mortality [ Time Frame: Day 28 ]
28-day all-cause mortality
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Change in PaO2/FiO2 [ Time Frame: Baseline to Day 5 ]
Relative change (%) from baseline in Oxygenation Index (PaO2 / FiO2) to day 5.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • Treatment Emergent Adverse Events [ Time Frame: Day1 to Day 60 ]
    Frequency, severity, and relatedness to study drug of serious and non-serious TEAEs
  • Safety Parameters [ Time Frame: Day 15, Day 28 ]
    Proportion of patients with an improvement in the 8-point ordinal scale
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Patients achieving early response [ Time Frame: Baseline to Day 7 ]
Number of patients (%) achieving an Early Response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Official Title  ICMJE A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
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)

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Severe COVID-19 Pneumonia
Intervention  ICMJE
  • Drug: SOC + IFX-1
    SOC + IFX-1
  • Drug: SOC + Placebo
    SOC + Placebo
Study Arms  ICMJE
  • Experimental: Arm A: SOC + IFX-1
    Intervention: Drug: SOC + IFX-1
  • Experimental: Arm B : SOC + Placebo
    Intervention: Drug: SOC + Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2022)
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
Actual Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   France,   Germany,   Mexico,   Netherlands,   Peru,   Russian Federation,   South Africa
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04333420
Other Study ID Numbers  ICMJE IFX-1-P2.9
2020-001335-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party InflaRx GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE InflaRx GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: A Vlaar, MD University Amsterdam
PRS Account InflaRx GmbH
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP