A pragmatic adaptive, randomized, controlled phase II/III multicenter study of IFX-1 in patients with severe COVID-19 pneumonia
- Conditions
- Corona virus infectionCOVID19 infection10047438
- Registration Number
- NL-OMON55215
- Lead Sponsor
- InflaRx GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 125
Patients must meet all the following criteria at randomization to be enrolled
into Phase III of the study:
1. At least 18 years of age or older
2. Patient on invasive mechanical ventilation (but not more than 48h post
intubation at time point of first IMP administration)
3. Patients with a PaO2 / FiO2 ratio of < 200 and > 60 at randomization (one
representative measurement within 6h before randomization)
4. SARS-CoV-2 infection confirmation (tested positive in last 14 days before
randomization with locally available test system)
Patients who fulfill any of the following criteria at randomization are not
eligible to participate in Phase III of the study:
1. Intubated > 48h at time point of first IMP administration
2. Expected stop of invasive ventilation or expected extubation in the next 24h
without additional intervention according to judgment of the investigator
3. 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
4. Known history of progressed COPD as evidenced by use of daily maintenance
treatment with long-acting bronchodilators or inhaled/oral corticosteroids for
> 2 months
5. Treatment of COVID-19 with investigational antibody treatment(s) which are
not approved or not included in locally adopted treatment guidelines (e.g.,
World Health Organization [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.)
6. 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.)
7. Received cytokine adsorption therapy in past 3 days
8. Known hypersensitivity to IFX-1 or any other ingredient of the study
medication
9. Serum or urine pregnancy test positive before randomization (required for
women of childbearing potential)
10. Received organ or bone marrow transplantation in past 3 months
11. Known cardio-pulmonary mechanical resuscitation in past 14 days
12. Patient moribund or expected to die in next 24h according to the judgment
of the investigator
13. Known to have received anti-cancer therapy for hemato-oncological disease
in past 4 weeks OR known to have active malignant disease at time point of
randomization
14. Known severe congestive heart failure (corresponding to e.g. New York Heart
Association [NYHA] Class III IV, left ventricular ejection fraction <40%)
15. Known history of chronic liver disease (Child-Pugh B or C)
16. Participating in or has participated in other investigational
interventional studies (drug or device) within the last 7 days before
randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Criteria for Evaluation<br /><br>Primary Endpoint:<br /><br>* 28-day all-cause mortality</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints:<br /><br>* Proportion of patients free of any renal replacement therapy within 28 days<br /><br>upon randomization<br /><br>* Proportion of patients developing acute kidney failure (estimated glomerular<br /><br>filtration rate [eGFR] < 15 mL/min/1.73m², assessed by the Chronic Kidney<br /><br>Disease Epidemiology Collaboration [CKD-EPI] equation requiring race<br /><br>information) during ICU stay and at day 28<br /><br>* Proportion of patients with an improvement in the 8 point ordinal scale (day<br /><br>15, day 28)<br /><br>* Frequency, severity, and relatedness to study drug of serious and non-serious<br /><br>TEAEs</p><br>