Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia

Inclusion Criteria:

- Male and female patients aged 18-80 years inclusive at screening.

- Clinically diagnosed with the SARS-CoV-2 virus by polymerase chain reaction (PCR) or
by other approved diagnostic methodology within 7 days prior to randomization.

- Hospitalized with COVID-19-induced pneumonia evidenced by chest X-ray, computed
tomography scan (CT scan) or magnetic resonance scan (MR scan), taken within 5 days
prior to randomization (within 24 hours in patients in the Netherlands).

- Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) ≤93% on
room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2)
<300 millimeter of mercury (mmHg) at screening. For cities located at altitudes
greater than 2500 m above sea level, these will be substituted with SpO2 <90% and
PaO2/FiO2 <250 mmHg.

- APACHE II score of ≥10 at screening.

- C-reactive protein (CRP) ≥20 mg/L and/or ferritin level ≥600 μg/L at screening.

- Body mass index of ≥18 to <40kg/m2 at screening.

Exclusion Criteria:

- Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal,
viral, or other infection (besides SARS-CoV-2).

- In the opinion of the investigator, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatment.

- Intubated prior to randomization.

- Previous treatment with anti-rejection and immunomodulatory drugs within the past 2
weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for
immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of
hydroxychloroquine, chloroquine or corticosteroids:

For COVID-19 infection, ongoing corticosteroid treatment is permitted at doses as per local
SoC.For non-COVID-19 disorders, ongoing corticosteroid treatment is permitted at doses up
to and including prednisolone 10 mg daily or equivalent.

In patients in the Netherlands only, the use of hydroxychloroquine and/or chloroquine in
the past 2 weeks are exclusionary.

- Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit
of normal detected within 24 hours at screening or at baseline (according to local
laboratory reference ranges) or other evidence if severe hepatic impairment
(Child-Pugh Class C).

- Absolute peripheral blood neutrophil count of ≤1000/mm3.

- Estimated GFR (eGFR) ≤30 mL/min/1.73m2 (based on CKD-EPI formula).

- Patients currently being treated with drugs known to be strong or moderate inducers of
isoenzyme CYP2C9 and/or strong inhibitors of CYP2C9 and/or strong inducers of
cytochrome P450, family 3, subfamily A (CYP3A) and the treatment cannot be
discontinued or switched to a different medication prior to starting study treatment.

- Patients with innate or acquired immunodeficiencies.

- Patients who have undergone solid organ or stem cell transplantation.