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).

NCT04452474 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CL04041080
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to evaluate the efficacy of a single dose of OKZ (64 mg) vs placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 29.

Conditions

COVID-19

Keywords

SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; 2019-nCoV; 2019 novel coronavirus; Respiratory disease; lung disease; COVID-19; coronavirus

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects achieving a change in their clinical status defined as improvement for at least 2 categories of the 5-points clinical status scale relative to baseline or in the "Not hospitalized" category

  Difference between OKZ and placebo groups in the percentage of subjects with an improvement of at least 2 categories of the 5-points clinical status scale relative to baseline or in the "Not hospitalized" category. The points of the scale are: 1. Not hospitalized; 2.Hospitalized, not requiring supplemental oxygen; 3.Hospitalized, supplemental oxygen, spontaneous breathing;4. Hospitalized, mechanical ventilation (invasive/non-invasive) or extracorporeal membrane oxygenation (ECMO); 5. Death

  at Day 29

Secondary Outcomes (2)

• Subjects' clinical status distribution based on 5-point clinical status scale during the study

  from Day 2 tо Day 15, Day 29, Day 60

• 28-day case fatality rates

  from Day 1 to Day 29

Other Outcomes (17)

• Case fatality rates during the intensive care unit (ICU) stay, at Days 7, 15, and 60

  from Day 1 to Day 60

• Duration of oxygen support

  From Day 1 to Day 60

• The time period until SpO2 ≥ 94% at ambient air during 2 consequence days is reached

  from Day 2 to Day 60

Study Arms (2)

Olokizumab 64 mg

EXPERIMENTAL

Subject randomized to receive subcutaneous single injection of 0,4 ml solution of Olokizumab on Day 1, in addition to standard therapy

Drug: Olokizumab 64 mg

Placebo

PLACEBO COMPARATOR

Subject randomized to receive subcutaneous single injection of 0,4 ml solution of Placebo on Day 1, in addition to standard therapy

Drug: Placebo

Interventions

Olokizumab 64 mg DRUG

solution for subcutaneous administration 160 mg/mL

Olokizumab 64 mg

Placebo DRUG

Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 diagnosis (confirmation of the presence of SARS-CoV-2 virus by rt-PCR) OR sample collection for SARS-CoV-2 virus rt-PCR if the results of SARS-CoV-2 virus rt-PCR are not available yet.
• Dated informed consent for participation in this study signed by the patient, or by the legally acceptable representative or when prior consent of the patient is not possible, and the subject's legally acceptable representative is not available, documented approval / favorable opinion by the IRB/IEC.
• SpO2 ≤93% (room air) or respiratory rate greater than 30/min (room air) or oxygenation index PaO2/FiO2 ≤300 mmHg (or SpO2/FiO2 ≤315 in the case PaO2/FiO2 assessment is not available (supplementary oxygen)
• Computed tomography findings: features consistent with bilateral COVID-19 viral pneumonia and no alternative explanation for these findings.

You may not qualify if:

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

Sponsors & Collaborators

• R-Pharm: lead
• Cromos Pharma LLC: collaborator
• Covance: collaborator

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Lung Diseases; Coronavirus Infections

Interventions

olokizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Officials

• Mikhail Samsonov

  Chief Medical Officer, R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: June 30, 2020
• Primary Completion: November 16, 2020
• Study Completion: January 29, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10