Status:
COMPLETED
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)
Lead Sponsor:
R-Pharm International, LLC
Collaborating Sponsors:
Data Management 365
K-Research, LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of the study was 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 sever...
Detailed Description
The study consisted of two phases: * Pilot phase: the first 189 patients were randomized in three groups to receive OKZ, RPH-104 (63 patients per group), followed by an interim analysis of efficacy a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- The presence of a voluntarily signed and dated Patient Informed Consent Form for participation in this study, or a record of an Medical Consilium decision justifying patient's participation in case of patient is unable to state his/her will.
- Having either of the following COVID-associated respiratory syndromes:
- pneumonia with oxygenation saturation SpO2 ≤93% (on room air) or respiratory rate greater than 30/min;
- Acute respiratory distress syndrome (ARDS) ( PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315 if PaO2 is not available).
- 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:
- A history of hypersensitivity to the study drugs (RPH-104 and/or OKZ), and/or their components.
- The 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)
- Severe renal failure: creatinine clearance \< 30 mL/min
- Septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm Hg and lactate ≥ 2 mmol/L in the absence of hypovolemia)
- The disease progresses to death over the next 24 hours, regardless of treatment, according to Investigator.
- Perforation of the gastrointestinal tract, a history of diverticulitis.
- Administration of plasma from COVID-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study.
- Recent (less then 5 half-lives) administration of tocilizumab or sarilumab;
- Recent (less then 5 half-lives) or planned during the current study period use of the following drugs:
- biologics (except RPH-104 or OKZ) with immunosuppressive effect, including, but not limited to: Interleukin-1 (IL-1) inhibitors (anakinra, rilonacept, canakinumab), IL- 6 inhibitors (except tocilizumab and sarilumab), IL-17A inhibitors (secukinumab), tumor necrosis factor α (TNFα) inhibitors (infliximab, adalimumab, etanercept, etc.), antiB-cell drugs, etc.
- other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to:
- high doses of glucocorticoids (equivalent to prednisolone \> 1 mg/kg) orally or parenterally;
- Janus kinase (JAK) kinase inhibitors; cyclophosphamide, etc.
- Concurrent participation in another clinical trial.
- Pregnancy, breastfeeding.
- A history of active tuberculosis, or active tuberculosis suspected by the Investigator.
Exclusion
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2020
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT04380519
Start Date
April 23 2020
End Date
July 24 2020
Last Update
January 24 2022
Active Locations (16)
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1
Private healthcare institution "Clinical Hospital" Russian Railways-Medicine named after N. A. Semashko"
Moscow, Russia, 109386
2
State Budget Healthcare Institution "City Clinical Hospital № 15 named after O.M. Filatov" of Moscow City Healthcare Department
Moscow, Russia, 111539
3
Federal State Budgetary Institution "Federal Center for Cerebrovascular Pathology and Stroke" of the Ministry of Health of the Russian Federation
Moscow, Russia, 117997
4
Federal State Autonomous Education Insitution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of Russian Federation (Sechenov University)
Moscow, Russia, 119991