Phase 3
N=399
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Severe COVID-19 Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04333420 ↗Enrolled (actual)
399
Serious AEs
60.9%
Results posted
Jun 2023
Primary outcome: Primary: Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) — 15.5; 31.9 percentage of change — p=0.3677
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IFX-1 + BSC (Drug); BSC (Drug); IFX-1 + SOC (Drug); Placebo + SOC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- InflaRx GmbH
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS) |
15.5; 31.9 | 0.3677 |
| PRIMARY Phase III: 28-day All-cause Mortality (FAS) |
54; 77; 115; 105; 8; 9 | 0.0941 |
| SECONDARY Phase II: All-cause 28-day Mortality (FAS) |
2; 4 | 0.6494 |
| SECONDARY Phase II: Early Response at Day 7 After Enrollment |
— | — |
| SECONDARY Phase II: Late Response Until Day 28 After Enrollment |
— | — |
| SECONDARY Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS) |
7.1; 17.6; 13.1; 36.0; 20.7; 27.8 | — |
| SECONDARY Phase III: 60-day All-cause Mortality (FAS) |
62; 87; 102; 93; 13; 11 | 0.0815 |
| SECONDARY Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS) |
82; 77; 86; 104; 9; 10 | 0.1553 |
| SECONDARY Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS) |
8; 12; 158; 168; 11; 11 | 0.4105 |
| SECONDARY Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS) |
160; 161 | 0.0422 sig |
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)
Eligibility Criteria
Phase II
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
Phase III:
Inclusion Criteria
- At least 18 years of age or older
- Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP administration)
- Patients with a PaO2 / FiO2 ratio of 60 at randomization (one representative measurement within 6h before randomization)
- SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)
Exclusion Criteria
- Intubated > 48 h at time point of first IMP administration
- Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator
- Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization
- Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months
- Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health [NIH] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment[s] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)
- At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.)
- Received cytokine adsorption therapy in past 3 days
- Known severe congestive heart failure (corresponding to e.g. NYHA Class III-IV, left ventricular ejection fraction <40%)
- Known history of chronic liver disease (Child-Pugh B or C)
Data sourced from ClinicalTrials.gov (NCT04333420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.