Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)

• Status: Completed
• Trial end date: 2020-07-24
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm International, LLC
• Collaborators: Data Management 365 LLC; K-Research, LLC

Criteria

Inclusion criteria:

• 1. Signed and dated patient's Informed consent for participation in this study, or record of a medical board decision justifying patient's participation in case of patient is unable to state his/her will.

• 2. Having either of the following COVID-associated respiratory syndromes:

• pneumonia with oxygenation parameters SpO2 ≤93% (on room air) or respiratory rate greater than 30/min;

• ARDS ( PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315 if PaO2 is not available).

• 3. COVID-19 diagnosis based on:

• laboratory-confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction method (PCR).

OR

• Bilateral changes in the lungs typical for COVID-19, based on chest computed tomography results.

Exclusion criteria:

• 1. Hypersensitivity to the study drugs (RPH-104 and/or OKZ), and/or its components.

• 2. Presence of any of the following laboratory abnormalities:

• absolute neutrophil counts < 0.5 x 10^9 L

• white blood cell count < 2 x 10^9 L

• platelet count <50 x 10^9 L

• Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) ≥ 3.0 x Upper Limit of Normal (ULN)

• 3. Severe renal failure: creatinine clearance < 30 mL/min

• 4. Septic shock (to maintain mean arterial pressure ≥ 65 mm Hg and lactate ≥ 2 mmol/L in the absence of hypovolemia, vasopressors are necessary)

• 5. Progression of disease up to the death in the following 24 hours regardless of treatment, as per Investigator's opinion

• 6. History of perforation of gastrointestinal tract, history of diverticulitis

• 7. Plasma infusion from convalescent COVID-19 donors within 4 weeks prior to patient inclusion and/or planned infusion during the study

• 8.Recent (less then 5 half-lives) administration of tocilizumab or sarilumab;

• 9. Recent (less then 5 half-lives) or planned during the current study period use of the following drugs:

• immunosuppressive biologics over than OKZ or RPH-104, including but not limited, Interleukin-1 (IL-1) inhibitors (rilonacept, anakinra, canakinumab) , IL-6 inhibitors (except tocilizumab and sarilumab), IL-17A inhibitors (secukinumab),tumor necrosis factor α (TNFα) inhibitors (adalimumab, infliximab, etanercept), anti-B-cell therapy and others

• other immunosuppressors except methotrexate dosed up to 25 mg per week, including but not limited:

1. high-dose glucocorticoids ( > 1mg/kg of prednisolone equivalent), oral and parental;

2. JAK inhibitors, cyclophosphamide, and others

• 10. Concurrent participation in another clinical trial.

• 11. Pregnancy or lactation

• 12. History of active tuberculosis, active tuberculosis suspected by Investigator