COVID-19 Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Adaptive, Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab vs. Placebo in Addition to Standard Treatment in Patients With Severe SARS-CoV-2 Infection (COVID-19)
Verified date | October 2021 |
Source | R-Pharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 29, 2021 |
Est. primary completion date | November 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Presence of any of the following laboratory abnormalities: absolute neutrophil counts <0,5 ? 10^9/L white blood cell count < 2 ? 10^9/L, platelet count < 50 ? 10^9/L, Alanine aminotransferase (?LT) and/or Aspartate aminotransferase (AST) =3,0 ? 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 (se?ukinumab, 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
R-Pharm | Covance, Cromos Pharma LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Case fatality rates during the intensive care unit (ICU) stay, at Days 7, 15, and 60 | Case fatality rates during the intensive care unit (ICU) stay at Days 7, 15, and 60 | from Day 1 to Day 60 | |
Other | Duration of oxygen support | Duration of oxygen support (if applicable) | From Day 1 to Day 60 | |
Other | The time period until SpO2 = 94% at ambient air during 2 consequence days is reached | The time period until SpO2 = 94% at ambient air during 2 consequence days is reached | from Day 2 to Day 60 | |
Other | Changes of oxygenation index PaO2/FiO2 from baseline | Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) | from Day 2 to Day 60 | |
Other | Duration of oxygen support (if applicable) | Duration of oxygen support (if applicable), in days | from Day 1 to Day 60 | |
Other | Duration of mechanical ventilation and/or ECMO (if applicable) | Duration of mechanical ventilation and/or ECMO (if applicable), in days | from Day 1 to Day 60 | |
Other | Duration of ICU stay (if applicable) | Duration of ICU stay (if applicable) | from Day 1 to Day 60 | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count | Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte count | Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte counts | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count | Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP) | Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP) | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin | Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer | Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets | Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides | Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides | from Day 2 and until the end of hospitalization, Day 29 as a maximum | |
Other | The time period until National Early Warning Score 2 (NEWS2) = 2 during 2 consequent days is reached | The time period until National Early Warning Score 2 (NEWS2) = 2 during 2 consequent days is reached | from Day 1 and until the end of hospitalization, Day 29 as a maximum | |
Other | The time period until National Early Warning Score 2 (NEWS2) = 4 during 2 consequent days is reached | The time period until National Early Warning Score 2 (NEWS2) = 4 during 2 consequent days is reached | from Day 1 and until the end of hospitalization, Day 29 as a maximum | |
Primary | 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 | Subjects' clinical status distribution based on 5-point clinical status scale during the study | Subjects' clinical status distribution based on 5-point clinical status scale during the study | from Day 2 t? Day 15, Day 29, Day 60 | |
Secondary | 28-day case fatality rates | 28-day case fatality rates | from Day 1 to Day 29 |
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