Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19).

Presence of any of the following laboratory abnormalities:

absolute neutrophil counts \<0,5 х 10\^9/L white blood cell count \< 2 х 10\^9/L, platelet count \< 50 х 10\^9/L, Alanine aminotransferase (АLT) and/or Aspartate aminotransferase (AST) ≥3,0 х Upper Limit of Normal (ULN)

Kidney injury with creatinine clearance \<30 mL/min.

Hypersensitivity to OKZ, and/or its components.

Septic shock (need for vasopressors to maintain mean arterial pressure ≥ 65 mm Hg and lactate ≥2 mmol / L in the absence of hypovolemia).

Estimated survival of less than 24 hours regardless of treatment.

History of perforation of the gastrointestinal tract, history of diverticulitis.

Recent (less than 5 half-lives), current or planned during the current study period use of immunosuppressive drugs:

biologics (except OKZ) with immunosuppressive effect, including, but not limited to: Interleukin-1 (IL-1) inhibitors (anakinra, rilonacept, canakinumab), IL-6 inhibitors (tocilizumab, sarilumab, siltuximab, etc.), IL-17A inhibitors (seсukinumab, etc.), Tumor Necrosis Factor-alpha (TNF-alpha) inhibitors (infliximab, adalimumab, etanercept, etc.), anti-B-cells therapy, etc.;.

other immunosuppressive drugs (excluding methotrexate in dose up to 25 mg/week), including but not limited to:

1. Glucocorticoids in high doses (\> 1 mg / kg equivalent of methylprednisolone) orally and parenterally;

2. JAK inhibitors; etc.

Concurrent participation in another clinical trial during 30 days before screening.

Pregnancy or lactation.

A history of active tuberculosis, or active tuberculosis suspected by the Investigator.

Administration of plasma from COVID-19 reconvalescent donors for 4 weeks prior to the patient's inclusion in the study and/or planned administration during the study

Patients who deteriorated into Category 4 of the 5-point clinical status scale within more than the last 24 hours.

What this study is about