None listed
Conditions
Interventions
Arm A and Arm B in accordance to the protocol. Type of group
Arm A : Experimental, 180 subjects, IFX-1 + SoC, IFX-1 (or placebo) concentrate solution for infusion, concentration 10 mg/ml, intravenous use, 22 days treatment with 800 mg IV at days 1,2,4,8,15 and 22.
Arm B: Control, 180 subjects, placebo + SoC, as above.
Sponsors
InflaRx GmbH,
Eligibility
Inclusion criteria
Inclusion criteria: 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 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Survival status will be assessed during the conduct of the study. Measure:28-day all-cause mortality Timepoints:28-days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1. Renal replacement therapy, extracorporeal membrane oxygenation (ECMO), mechanical ventilation 2. Assessed by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation). 3. Ordinal scale score will be documented at the visits specified in the SoA, including the Date. Measure:1. Patients free of renal replacement therapy 2. Patients developing acute kidney failure 3. Patients with an improvement in the 8-point ordinal scale. Timepoints:1. Within 28 days upon randomization. 2. During ICU stay and at day 28. 3. Day 15, Day 28 | — |
Countries
Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, United Kindgdom
Contacts
Public ContactRosmery Osorio
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed