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Olokizumab 64 mgWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug2914 newborns from covid 19 positive mothers Wiki 0.71
drug2005 RPH-104 80 mg Wiki 0.71
drug2172 STC-19 score Wiki 0.71
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials


1 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)

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

NCT04380519 COVID-19 Biological: RPH-104 80 mg Drug: Olokizumab 64 mg Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients, responded to the study therapy, in each of the treatment groups. The patient can be considered as the therapy responder, in case tocilizumab or sarilumab were not administered and there is an improvement of a clinical status at least by 1 point on a 6-points COVID-19 scale, where 1 point means most favorable outcome, 6 points means most undesirable outcome.

Measure: Proportion of patients, responded to the study therapy, in each of the treatment groups

Time: Day 15

Secondary Outcomes

Description: Changes of patients' clinical status on a 6 points ordinal scale over time

Measure: Changes of patients' clinical status on a 6 points ordinal scale over time

Time: from Day 2 until Day 15, Day 29

Description: Mortality rate over the follow-up period

Measure: Mortality rate over the follow-up period

Time: from Day 1 until Day 29

Description: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.

Measure: Improvement of the patient's clinical status by at least 2 points on a 6-point ordinal scale in the absence of tocilizumab or sarilumab administration.

Time: on screening and then from Day 1 until Day 29

Description: Proportion of patients received tocilizumab or sarilumab due to COVID-19

Measure: Proportion of patients received tocilizumab or sarilumab due to COVID-19

Time: from Day 1 until the Day 29

Other Outcomes

Description: Proportion of patients having National Early Warning Score 2 (NEWS2) of ≤ 4 maintained for 2 consecutive days

Measure: Proportion of patients having National Early Warning Score 2 of ≤ 4 maintained for 2 consecutive days

Time: from day 3 until day 15

Description: Time to a NEWS2 of ≤ 2 maintained for two consecutive days

Measure: Time to a NEWS2 of ≤ 2 maintained for two consecutive days

Time: from day 1 until day 15

Description: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, CRP, ferritin (if applicable), D-dimer (if applicable)

Measure: Changes from baseline of cytokine storm surrogate markers: white blood counts, lymphocyte counts, neutrophils counts, C-Reactive protein (CRP), ferritin (if applicable), D-dimer (if applicable)

Time: Day 2, Day 3, Day5, Day 7, Day 15

Description: Mortality during an ICU stay, on days 7, 15, 29 of the study

Measure: Mortality during an ICU stay, on days 7, 15, 29 of the study

Time: On Day 7, Day 15, Day 29

Description: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days

Measure: Time to increase of oxygen saturation SpO2 ≥ 94% n the absence of oxygen support maintained for two consecutive days

Time: from Day 2 until Day 15

Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period

Measure: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable) during hospitalization period

Time: On Day 1 and from Day 2 until Day 15

Description: Duration of ICU stay measured in days

Measure: Duration of ICU stay measured in days

Time: from Day 2 until Day 15

Description: Changes from baseline (if applicable) in severity of ARDS according to WHO criteria

Measure: Changes from baseline (if applicable) in severity of Acute Respiratory Distress Syndrome (ARDS) according to World Health Organization (WHO) criteria

Time: from Day 1 until Day 15

Description: Duration of mechanical ventilation and EMO (if applicable) measured in days

Measure: Duration of mechanical ventilation and Extracorporeal Membrane Oxygenation (EMO) (if applicable) measured in days

Time: from Day 2 until Day 15

Description: Duration of oxygen support (if applicable) measured in days

Measure: Duration of oxygen support (if applicable) measured in days

Time: from Day 1 until Day 15

Description: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days

Measure: Proportion of patients having National Early Warning Score 2 of ≤ 2 maintained for 2 consecutive days

Time: from day 3 until day 15

Description: Time to a NEWS2 of ≤ 4 maintained for two consecutive days

Measure: Time to a NEWS2 of ≤ 4 maintained for two consecutive days

Time: from day 1 until day 15

Description: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)

Measure: Time to improvement in severity of ARDS according to WHO criteria in one category changing from baseline (if applicable)

Time: On Day 1 and from Day 2 until Day 15

Description: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)

Measure: Time to fever resolution i.e. setting of axillary body temperature <38 °C without antipyretics when measured for 2 consecutive days (if applicable)

Time: from day 1 until day 15

Description: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale

Measure: Time to improvement of clinical status by 1 point on a 6-points COVID-19 scale

Time: from day 1 until day 29

Description: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale

Measure: Time to improvement of clinical status by 2 points on a 6-points COVID-19 scale

Time: from day 1 until day 29

Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study

Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study

Time: from Day 1 until Day 29

Description: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable

Measure: Proportion of patients with the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study, excluding the patients moved to the category 6, if applicable

Time: from Day 1 until Day 29

Description: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)

Measure: Time to the deterioration of clinical status by 1 point on a 6-points COVID-19 scale during the study (if applicable)

Time: from Day 1 until Day 29

2 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)

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.

NCT04452474 COVID-19 Drug: Olokizumab 64 mg Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: 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

Measure: 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

Time: at Day 29

Secondary Outcomes

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

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

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

Description: 28-day case fatality rates

Measure: 28-day case fatality rates

Time: from Day 1 to Day 29

Other Outcomes

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

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

Time: from Day 1 to Day 60

Description: Duration of oxygen support (if applicable)

Measure: Duration of oxygen support

Time: From Day 1 to Day 60

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

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

Time: from Day 2 to Day 60

Description: Changes of oxygenation index PaO2/FiO2 from baseline (if applicable)

Measure: Changes of oxygenation index PaO2/FiO2 from baseline

Time: from Day 2 to Day 60

Description: Duration of oxygen support (if applicable), in days

Measure: Duration of oxygen support (if applicable)

Time: from Day 1 to Day 60

Description: Duration of mechanical ventilation and/or ECMO (if applicable), in days

Measure: Duration of mechanical ventilation and/or ECMO (if applicable)

Time: from Day 1 to Day 60

Description: Duration of ICU stay (if applicable)

Measure: Duration of ICU stay (if applicable)

Time: from Day 1 to Day 60

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: white blood count

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte counts

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: lymphocyte count

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: neutrophils count

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP)

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: C-reactive protein (CRP)

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: ferritin

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker:D-dimer

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker:platelets

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides

Measure: Changes from baseline of COVID-19 cytokine storm surrogate marker: triglycerides

Time: from Day 2 and until the end of hospitalization, Day 29 as a maximum

Description: The time period until National Early Warning Score 2 (NEWS2) ≤ 2 during 2 consequent days is reached

Measure: The time period until National Early Warning Score 2 (NEWS2) ≤ 2 during 2 consequent days is reached

Time: from Day 1 and until the end of hospitalization, Day 29 as a maximum

Description: The time period until National Early Warning Score 2 (NEWS2) ≤ 4 during 2 consequent days is reached

Measure: The time period until National Early Warning Score 2 (NEWS2) ≤ 4 during 2 consequent days is reached

Time: from Day 1 and until the end of hospitalization, Day 29 as a maximum


No related HPO nodes (Using clinical trials)