Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

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 < 200 and > 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)