Phase 3
Completed N=372
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)
Source: ClinicalTrials.gov NCT04380519 ↗Enrolled (actual)
372
Serious AEs
8.9%
Results posted
Jan 2022
Primary outcomePrimary: Proportion of Responders in Each Treatment Group — 88; 98; 87 Participants — p=0.434
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Responders in Each Treatment Group |
88; 98; 87 | 0.434 |
| SECONDARY Change Over Time in the Clinical Status of Patients Using a 6-point Ordinal Scale |
88; 99; 96; 13; 8; 7 | — |
| 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 |
94; 103; 94 | 0.393 |
| SECONDARY The Proportion of Patients Who Received Tocilizumab or Sarilumab for COVID-19 During the Study |
10; 5; 15 | — |
| SECONDARY Mortality Rate During the Study |
14; 9; 6 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04380519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.