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
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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 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 |

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 |
- Mortality [ Time Frame: Day 28 ]28-day all-cause mortality
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | A Vlaar, MD | University Amsterdam |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 related severe pneumonia |
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 |