A PRAGMATIC ADAPTIVE RANDOMIZED CONTROLLED PHASE II/III MULTICENTER STUDY OF IFX-1 IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA --- PANAMO”
- Conditions
- -J22 Unspecified acute lower respiratory infectionUnspecified acute lower respiratory infectionJ22
- Registration Number
- PER-081-20
- Lead Sponsor
- InflaRx GmbH,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
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 randomization)
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 randomization
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., 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. Known hypersensitivity to IFX-1 or any other ingredient of the study medication
8. Serum or urine pregnancy test positive before randomization (required for women of childbearing potential)
9. Received organ or bone marrow transplantation in past 3 months
10. Known cardio-pulmonary mechanical resuscitation in past 14 days
11. Received cytokine adsorption therapy in past 3 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 (NYHA Class III-IV; see Appendix 8)
15. Known history of chronic liver disease (Child-Pugh B or C; see Appendix 9)
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 <br>Outcome name:Survival status will be assessed during the conduct of the study.<br>Measure:28-day all-cause mortality<br>Timepoints:28-days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:1. Renal replacement therapy, extracorporeal membrane oxygenation (ECMO), mechanical ventilation<br>2. Assessed by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation).<br>3. Ordinal scale score will be documented at the visits specified in the SoA, including the Date.<br>Measure:1. Patients free of renal replacement therapy<br>2. Patients developing acute kidney failure<br>3. Patients with an improvement in the 8-point ordinal scale.<br>Timepoints:1. Within 28 days upon randomization.<br>2. During ICU stay and at day 28.<br>3. Day 15, Day 28<br>