COVID-19 Clinical Trial
Official title:
An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)
Verified date | January 2022 |
Source | R-Pharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study.
Status | Completed |
Enrollment | 372 |
Est. completion date | July 24, 2020 |
Est. primary completion date | July 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 1. 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. 2. 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). 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. A history of hypersensitivity to the study drugs (RPH-104 and/or OKZ), and/or their components. 2. 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) 3. Severe renal failure: creatinine clearance < 30 mL/min 4. Septic shock (vasopressors are required to maintain mean arterial pressure = 65 mm Hg and lactate = 2 mmol/L in the absence of hypovolemia) 5. The disease progresses to death over the next 24 hours, regardless of treatment, according to Investigator. 6. Perforation of the gastrointestinal tract, a history of diverticulitis. 7. Administration of plasma from COVID-19 convalescent donors within 4 weeks before study enrollment and/or planned administration 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: - 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 a (TNFa) 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: 1. high doses of glucocorticoids (equivalent to prednisolone > 1 mg/kg) orally or parenterally; 2. Janus kinase (JAK) kinase inhibitors; cyclophosphamide, etc. 10. Concurrent participation in another clinical trial. 11. Pregnancy, breastfeeding. 12. A history of active tuberculosis, or active tuberculosis suspected by the Investigator. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | ?? "State Company "Medsi" based on Clinical Hospital ?1" | Moscow | |
Russian Federation | 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 | |
Russian Federation | Federal State Autonomous Education Institution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of the Russian Federation (Sechenov University) | Moscow | |
Russian Federation | Federal State Budget Institution "National Medicine Research Center on Cardiology" By Ministry of Healthcare of Russian Federation | Moscow | |
Russian Federation | Federal State Budgetary Institution "Central Clinical Hospital with Polyclinic" of Administrative Directorate of the President of the Russian Federation | Moscow | |
Russian Federation | Federal State Budgetary Institution "Federal Center for Cerebrovascular Pathology and Stroke" of the Ministry of Health of the Russian Federation | Moscow | |
Russian Federation | Moscow State Budget Institution of Healthcare "Scientific Research Institute of Emergency Medicine named after N.V. Sklifosovsky of Moscow Department of Healthcare" | Moscow | |
Russian Federation | Private healthcare institution "Clinical Hospital" Russian Railways-Medicine named after N. A. Semashko" | Moscow | |
Russian Federation | State Budget Healthcare Institution "City Clinical Hospital ? 15 named after O.M. Filatov" of Moscow City Healthcare Department | Moscow | |
Russian Federation | State Budget Institution of Healthcare "City Clinical Hospital #52", Moscow City Healthcare Department | Moscow | |
Russian Federation | State budgetary healthcare institution City Clinical Hospital named after S.I. Spasokukotsky Department of Health of the city of Moscow City Clinical Hospital No. 50 | Moscow | |
Russian Federation | Federal State Budgetary Educational Institution of Higher Education "Volga Research Medical University" of the Ministry of Health of the Russian Federation | Nizhniy Novgorod | |
Russian Federation | Saint-Petersburg State Budget Institution of Healthcare "City Hospital ?40" | Saint Petersburg | |
Russian Federation | Federal Budgetary State Healthcare Institution "National Medical Research Center named after B.A. Almazov" | Saint-Petersburg | |
Russian Federation | Budgetary Health Institution Voronezh Regional Clinical Hospital ?1 | Voronezh | |
Russian Federation | State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Hospital of War Veterans" | Yaroslavl |
Lead Sponsor | Collaborator |
---|---|
R-Pharm International, LLC | Data Management 365 LLC, K-Research, LLC |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Responders in Each Treatment Group | Proportion of patients, responded to the study therapy, in each of the treatment groups. A responder is a patient who has not received tocilizumab or sarilumab and who has a clinical status improvement of =1 point on the 6-point COVID-19 scale (where 1 is the most favorable outcome and 6 is the most undesirable outcome) 15 days after the administration of the study drug: Not hospitalized, no activity limitations. Not hospitalized, limited activity. Hospitalized, not requiring supplemental oxygen. Hospitalized, supplemental oxygen with independent breathing. Hospitalized; mechanical ventilation (invasive/non-invasive) or Extracorporeal membrane oxygenation (ECMO). Death. |
Day 15 | |
Secondary | Change Over Time in the Clinical Status of Patients Using a 6-point Ordinal Scale | Changes of patients' clinical status on a 6 points ordinal scale (where 1 was the most favorable outcome and 6 was the most undesirable outcome) over time. The 6-point ordinal scale included the following categories: Not hospitalized, no activity limitations. Not hospitalized, limited activity. Hospitalized, not requiring supplemental oxygen. Hospitalized, supplemental oxygen, with independent breathing. Hospitalized, mechanical ventilation (invasive/non-invasive) or ECMO. Death. |
from Day 2 until Day 15, Day 29 | |
Secondary | The Proportion of Patients With an Improvement in Clinical Status by 2 or More Points on the 6-point Ordinal Scale During the Study With no Use of Tocilizumab or Sarilumab | The proportion of patients with an improvement in clinical status by 2 or more points on the 6-point ordinal scale (where 1 was the most favorable outcome and 6 was the most undesirable outcome) during the study with no use of tocilizumab or sarilumab. The 6-point ordinal scale included the following categories: Not hospitalized, no activity limitations. Not hospitalized, limited activity. Hospitalized, not requiring supplemental oxygen. Hospitalized, supplemental oxygen, with independent breathing. Hospitalized, mechanical ventilation (invasive/non-invasive) or ECMO. Death. |
Day 29 | |
Secondary | The Proportion of Patients Who Received Tocilizumab or Sarilumab for COVID-19 During the Study | The proportion of patients who received tocilizumab or sarilumab for COVID-19 during the study | from Day 2 until the Day 29 | |
Secondary | Mortality Rate During the Study | Mortality rate over the follow-up period of the study | from Day 1 until Day 29 |
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