COVID-19Phase 3RESETNCT05187793
Study of Efficacy of Different Treatment Regimens of Olokizumab
A Phase 3 study testing Olokizumab and Standard therapy in people with COVID-19, run by R-Pharm at 5 sites in Russia.
Trial summary
The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Olokizumab and Standard therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 5 sitesRussia
- Study dates
- 8 Jul 2021to Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent for participation in this study.
- Hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus (COVID-19).
- Moderate COVID-19. Moderate course of the disease is characterized by pneumonia on chest computed tomography (CT) (CT-1,2 stages) and body temperature > 38 °C, in combination with 1 or more of the following:
- SpO2 <95%,
- respiratory rate > 22,
- dyspnea on exertion,
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- C-reactive protein (CRP) level> 10 mg / l,
- one of the following risk factors: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years.
- The presence of signs of hyperinflammation. Signs of hyperinflammation are body temperature ≥ 38 °C for 2 days or more, combined with 1 or more of the following:
- CRP level > 3 Upper Normal Limit (UNL),
- White blood cell count - 2.0-3.5 × 10^9 / l,
- Absolute lymphocyte count - 1.0-1.5 × 10^9 / l
- Infection caused by the SARS-CoV-2 confirmed by of Polymerase chain reaction (PCR) test or an express test for antigen / antibodies to SARS-CoV-2 framework of the protocol.
- Ability to follow protocol requirements and perform all clinical trial procedures.
- The willingness of the participants and their sexual partners to use reliable methods of contraception, during the entire study and at least 3 months after the treatment completion. This requirement does not apply to participants who have undergone surgical sterilization as well as to women with permanent cessation of menstruation, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status (eg, appropriate age). Reliable methods of contraception involve the use of one barrier method in combination with one of the following: spermicides, intrauterine spiral/oral contraceptives in a sexual partner.
- Willingness not to drink alcohol during the entire study.
- Additional inclusion criteria for the pharmacokinetics (PK) subgroup:
- Signed informed consent to participate in the additional study of pharmacokinetics.
- Body mass index 18.5 - 35.0 kg/m2.
- The ability of the patient, by the opinion of the investigator, to participate in the additional study of pharmacokinetics and to provide the required number of blood samples.
Who cannot join
- Hypersensitivity to olokizumab and / or other components of the study drug.
- Contraindications to favipiravir or glucocorticosteroids or Janus kinase inhibitors (baricitinib).
- Signs of a severe or extremely severe course of COVID-19, such as:
- altered level of consciousness, agitation,
- the need for / use of Non-invasive ventilation (NIV) / Adaptive lung ventilation (ALV) / Extracorporeal membrane oxygenation (ECMO) at screening,
- hemodynamic instability eg systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg and urine output less than 20 ml / hour,
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- CT-3,4 stage on chest CT, signs of Acute respiratory distress syndrome (ARDS),
- arterial blood lactate > 2 mmol / l,
- quick Sequential Organ Failure Assessment (qSOFA) > 2 points.
- Any of the following laboratory abnormalities:
- Hemoglobin <80 g / l,
- Absolute neutrophil count <0.5 x 10^9 / l,
- White blood cell count <2.0 x 10^9 / l,
- Platelet count <50 x 10^9 / l,
- Alanine transaminase (ALT) and / or Aspartate aminotransferase (AST) ≥ 3.0 x UNL.
- Severe renal failure: creatinine clearance < 30 ml / min.
- Confirmed sepsis with non-COVID-19 pathogens and procalcitonin levels > 0.5 ng / ml.
- Prior hepatitis B and / or C virus infection.
- High probability of disease progression to death within the next 24 hours, regardless of therapy, by the opinion of the investigator.
- Concomitant diseases associated with a poor prognosis (with the exception of those listed in inclusion criteria No. 3: diabetes mellitus, severe cardiovascular disease, chronic renal failure, cancer, obesity, or age ≥ 65 years).
- Immunosuppressive therapy for organ transplantation.
- Recent (less than 5 half-lives) or prescribed at screening:
- Olokizumab (use or prescription prior to study randomization);
- Biological drugs with immunosuppressive effects, including, but not limited to:Interleukin 1 (IL-1) inhibitors (anakinra, canakinumab), IL-6 receptor inhibitors (tocilizumab, sarilumab, levilimab), IL-17 (secukinumab, netakimab), tumor necrosis factor α inhibitors (TNFα) (infliximab, adalimumab, etanercept, etc.), anti-B-cell drugs, and others;
- Immunosuppressive drugs (including, but not limited to):
- glucocorticoids in high doses (> 1 mg / kg prednisolone equivalent) orally or parenterally;
- Janus kinase (JAK) kinase inhibitors;
- cyclophosphamide, etc.
- History of active tuberculosis or suspected active tuberculosis.
- Simultaneous participation in another clinical trial.
- Pregnancy or breastfeeding at screening; planning pregnancy during the entire study and within 3 months after the completion of treatment.
- Any information from anamnesis that may lead to a complicated interpretation of the study results or create additional risk for the patient as a result of participation in the study.
- Known (from history) or suspected abuse of alcohol, psychotropic drugs; drug addiction.
- Subjects with a history or presence of any psychiatric disorder(s).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department"
Moscow, 105187
Federal State Budgetary Institution "Central Clinical Hospital with a Polyclinic" of Presidential Administration of the Russian Federation
Moscow, 121359
State Budgetary Healthcare Institution "City Clinical Hospital № 52 of Moscow Healthcare Department"
Moscow, 123182
State Budgetary Healthcare Institution "Infectious Diseases Hospital No. 1 of Moscow Healthcare Department"
Moscow, 125367
State Budgetary healthcare Institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh, 394066
About this study
Official title: A Multicenter, Open-label, Randomized Study of the Efficacy and Safety of Artlegia (INN: Olokizumab) New Dosing Regimen in Patients With Coronavirus Infection (COVID-19) With Signs of Hyperinflammation
The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation.
This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
Read the detailed description
The study has an adaptive design. According to the initial calculation of the sample size it was planned to include about 204 patients in the study. After interim analyzing of the data of the first 100 randomized patients a decision about the final sample size was made. The size of the intent-to-treat (ITT) population for the final efficacy analysis at the primary endpoint is 180 patients. Taking into account the probability of dropping out up to 10% of patients, 198 patients were planned to be randomized into the study, no more than 220 patients were planned to be screened.
The study will include the following periods:
- Screening period lasting up to 2 days (days -1-0). During this period patient's eligibility assessment will be performed;
- Treatment period: up to 10 days. Treatment period starts from the end of the screening (days 1-10) and includes randomization following by a 10 days of standard therapy with or without olokizumab and patient monitoring (laboratory tests, electrocardiogram (ECG), chest computed tomography (CT));
- Short-term follow-up period up to 28 days (days 11 through 28). It includes procedures of patient monitoring (laboratory tests, ECG, chest CT) on days 14 (± 2) and 28 (± 2).
- Long-term follow-up period: up to 180 days (days 29 through 180). Includes telephone contacts with the patient on days 45, 60, 90 and 180.
Eligible patients will be randomized to one of 2 treatment groups to receive olokizumab (OKZ) 128 mg i.v. infusion (one or two single doses) against the background of standard therapy, or standard therapy alone.
In OKZ group study drug olokizumab 128 mg is administered as a single intravenous infusion. A comprehensive assessment of the clinical and laboratory response is performed daily within 5 days (120 hours) after the first injection. If there is no response to therapy or the response is insufficient, the repeated dose of OKZ, 128 mg, is administered.
As standard anti-inflammatory therapy, patients in both groups will receive baricitinib (at the standard recommended dose of 4 mg / 1 time per day, for 7 days) and low doses of glucocorticosteroids (dexamethasone at doses of 4-20 mg / day or methylprednisolone at a dose of 1 mg / kg / intravenous injection every 12 hours).
With an observed clinical deterioration (fever increase, dyspnea, oxygen saturation decrease, the appearance / increase in the need for oxygen support) after repeated infusion of OKZ in the main group (at least 24 hours from the first infusion started), or after 24 hours or more from the start of therapy in the comparison group, the patient is considered "not responding" to therapy and requiring another anti-inflammatory treatment regimens.
Standard therapy also includes etiotropic therapy for COVID-19, as well as symptomatic and anticoagulant therapy.
Etiotropic therapy. Favipiravir will be used in recommended dosage regimens according to temporary guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" of the Ministry of Health of Russian Federation.
Patients who have started etiotropic therapy with favipiravir or remdesivir prior to randomization will continue the initiated treatment.
Сlinical status will be assessed daily in the first 10 days, then on days 14, 21, 28, 45, 60, 90 and 180, vital signs - three times daily in the first 5 days, once daily on days 6-10, then on days 14 and 28, chest CT - on days 7, 14 and 28; laboratory parameters - on days 1 - 5, 10, 14, 28.
On day 7 primary endpoint of patient's clinical recovery (defined as score of 3 or less on a 10-point ordinal scale of clinical improvement) will be assessed. The last patient's visit to the study site will be the visit on Day 28. On Days 45, 60, 90 and 180 the phone follow-up will be performed.
In olokizumab group, eligible subjects will be selected to participate in pharmacokinetic analysis. Blood samples for the evaluation of olokizumab pharmacokinetics will be taken before the infusion of olokizumab and in 2 h, 4 h, 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 192 h, 216 h, 240 h, 336 h and 672 h after the first administration of the drug (since the start of infusion).
Expected study duration for each patient will be 182 (± 2) days, including screening periods (2 days), therapy and short-term follow-up (28 (± 2) days), and long-term extended follow-up (152 (± 2) 2 days).
- Conditions
- COVID-19
- Being tested
- Olokizumab, Standard therapy
- Keywords
- SARS-CoV-2, 2019-nCoV, Severe acute respiratory syndrome coronavirus 2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlokizumabDrug
Olokizumab, 128 mg, solution for subcutaneous administration 160 mg/mL
Standard therapyDrug
Standard treatment including:
- Baricitinib, 4 mg, film coated tablets
- Favipiravir, 200 mg, film coated tablets
- Dexamethasone IV or IM OR Methylprednisolone IV
| Study group | Role | What they receive |
|---|---|---|
| Olokizumab | Experimental | Subject randomized to receive intravenous infusion of 0,8 ml solution of Olokizumab, one (128 mg), or two (256 mg) doses, in addition to standard therapy in line with the current temporary guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" of the Ministry of Health of Russian Federation.
Standard therapy includes:
* Baricitinib, p.o., 4 mg once daily for 7 days
* Favipiravir, p.o.,
* for patients weighing <75 kg: 1600 mg twice daily on Day 1, then 600 mg twice daily from the 2nd to the 10th day;
* for patients weighing ≥ 75 kg: 1800 mg twice daily on Day 1, then 800 mg twice daily from the 2nd to the 10th day; (Patients who have started etiotropic therapy with favipiravir or remdesivir prior to randomization will continue the initiated treatment.)
* dexamethasone at doses of 4 - 20 mg / day or methylprednisolone at a dose of 1 mg / kg / intravenous injection every 12 hours. Receives: Drug: Olokizumab; Drug: Standard therapy |
| Standard therapy | Active comparator | Standard therapy in line with the current temporary guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" of the Ministry of Health of Russian Federation including:
* Baricitinib, p.o., 4 mg once daily for 7 days
* Favipiravir, p.o.,
* for patients weighing <75 kg: 1600 mg twice daily on Day 1, then 600 mg twice daily from the 2nd to the 10th day;
* for patients weighing ≥ 75 kg: 1800 mg twice daily on Day 1, then 800 mg twice daily from the 2nd to the 10th day; (Patients who have started etiotropic therapy with favipiravir or remdesivir prior to randomization will continue the initiated treatment.)
* dexamethasone at doses of 4 - 20 mg / day or methylprednisolone at a dose of 1 mg / kg / intravenous injection every 12 hours. Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical recovery rate at day 7
Clinical recovery defined as score of 3 or less on a 10-point ordinal scale of clinical improvement.
(From 0 "Healthy - no clinical manifestations, no viral RNA detected" to 10 "Death".) 7 days are counted from the day of the first administration / intake of study therapy / comparison therapy, depending on study group.
Criteria for transition from category "4" to category "3" (criteria for potential discharge): body temperature < 37 °C; respiratory rate ≤ 20 per minute; SpO2 ≥ 95% without oxygen support, CRP < 10 mg/l. If any emergency procedures should be prescribed and/or signs of progression on CT are detected, the patient cannot be discharged/transferred to category "3".
(In the case of the "rescue" therapy use or the development of clinical deterioration (an increase in the score by 1 point or more) during the follow-up period in a previously recovered patient, the patient is not considered as a "responder", i.e., who has reached the primary endpoint.)
Measured: Up to day 7
Secondary outcomes (8)
Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 28, depending on study group
Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 28, depending on study group
Measured: Up to day 28
CRP normalization rate
Normalization is defined as CRP blood level within normal range (< 10 mg/l), assessed on days 5, 10, 14, 28, depending on study group.
Measured: Up to Day 28
Ferritin normalization rate
Normalization is defined as ferritin blood level within normal range, assessed on days 5, 10, 14, 28, depending on study group.
Measured: Up to Day 28
D-dimer normalization rate
Normalization is defined as D-dimer blood level within normal range, assessed on days 5, 10, 14, 28, depending on study group.
Measured: Up to Day 28
Mean CRP levels
Mean CRP levels assessed on days 5, 10, 14, 28, depending on study group
Measured: Up to Day 28
Mean ferritin levels
Mean ferritin levels assessed on days 5, 10, 14, 28, depending on study group
Measured: Up to Day 28
Mean D-dimer levels
Mean D-dimer levels assessed on days 5, 10, 14, 28, depending on study group
Measured: Up to Day 28
Rate of prescribing other anti-inflammatory therapy regimens (rescue therapy), depending on study group
Rate of prescribing other anti-inflammatory therapy regimens (rescue therapy), depending on study group
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start8 Jul 2021
- Primary completion31 Oct 2022
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor, Group of companies Medsi, JSС
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187793
- Sponsor's protocol ID
- CL04041094
- Acronym
- RESET
- Status last verified
- Feb 2023
- First submitted
- 24 Dec 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Study of the Efficacy and Safety of Artlegia (INN: Olokizumab) New Dosing Regimen in Patients With Coronavirus Infection (COVID-19) With Signs of Hyperinflammation
- ClinicalTrials.gov ID
- NCT05187793
- Acronym / sponsor ID
- RESET / CL04041094
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, 2019-nCoV, Severe acute respiratory syndrome coronavirus 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor, Group of companies Medsi, JSС
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation.
This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.
Detailed description
The study has an adaptive design. According to the initial calculation of the sample size it was planned to include about 204 patients in the study. After interim analyzing of the data of the first 100 randomized patients a decision about the final sample size was made. The size of the intent-to-treat (ITT) population for the final efficacy analysis at the primary endpoint is 180 patients. Taking into account the probability of dropping out up to 10% of patients, 198 patients were planned to be randomized into the study, no more than 220 patients were planned to be screened.
The study will include the following periods:
- Screening period lasting up to 2 days (days -1-0). During this period patient's eligibility assessment will be performed;
- Treatment period: up to 10 days. Treatment period starts from the end of the screening (days 1-10) and includes randomization following by a 10 days of standard therapy with or without olokizumab and patient monitoring (laboratory tests, electrocardiogram (ECG), chest computed tomography (CT));
- Short-term follow-up period up to 28 days (days 11 through 28). It includes procedures of patient monitoring (laboratory tests, ECG, chest CT) on days 14 (± 2) and 28 (± 2).
- Long-term follow-up period: up to 180 days (days 29 through 180). Includes telephone contacts with the patient on days 45, 60, 90 and 180.
Eligible patients will be randomized to one of 2 treatment groups to receive olokizumab (OKZ) 128 mg i.v. infusion (one or two single doses) against the background of standard therapy, or standard therapy alone.
In OKZ group study drug olokizumab 128 mg is administered as a single intravenous infusion. A comprehensive assessment of the clinical and laboratory response is performed daily within 5 days (120 hours) after the first injection. If there is no response to therapy or the response is insufficient, the repeated dose of OKZ, 128 mg, is administered.
As standard anti-inflammatory therapy, patients in both groups will receive baricitinib (at the standard recommended dose of 4 mg / 1 time per day, for 7 days) and low doses of glucocorticosteroids (dexamethasone at doses of 4-20 mg / day or methylprednisolone at a dose of 1 mg / kg / intravenous injection every 12 hours).
With an observed clinical deterioration (fever increase, dyspnea, oxygen saturation decrease, the appearance / increase in the need for oxygen support) after repeated infusion of OKZ in the main group (at least 24 hours from the first infusion started), or after 24 hours or more from the start of therapy in the comparison group, the patient is considered "not responding" to therapy and requiring another anti-inflammatory treatment regimens.
Standard therapy also includes etiotropic therapy for COVID-19, as well as symptomatic and anticoagulant therapy.
Etiotropic therapy. Favipiravir will be used in recommended dosage regimens according to temporary guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" of the Ministry of Health of Russian Federation.
Patients who have started etiotropic therapy with favipiravir or remdesivir prior to randomization will continue the initiated treatment.
Сlinical status will be assessed daily in the first 10 days, then on days 14, 21, 28, 45, 60, 90 and 180, vital signs - three times daily in the first 5 days, once daily on days 6-10, then on days 14 and 28, chest CT - on days 7, 14 and 28; laboratory parameters - on days 1 - 5, 10, 14, 28.
On day 7 primary endpoint of patient's clinical recovery (defined as score of 3 or less on a 10-point ordinal scale of clinical improvement) will be assessed. The last patient's visit to the study site will be the visit on Day 28. On Days 45, 60, 90 and 180 the phone follow-up will be performed.
In olokizumab group, eligible subjects will be selected to participate in pharmacokinetic analysis. Blood samples for the evaluation of olokizumab pharmacokinetics will be taken before the infusion of olokizumab and in 2 h, 4 h, 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 192 h, 216 h, 240 h, 336 h and 672 h after the first administration of the drug (since the start of infusion).
Expected study duration for each patient will be 182 (± 2) days, including screening periods (2 days), therapy and short-term follow-up (28 (± 2) days), and long-term extended follow-up (152 (± 2) 2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olokizumab | Experimental | Drug: Olokizumab, Drug: Standard therapySubject randomized to receive intravenous infusion of 0,8 ml solution of Olokizumab, one (128 mg), or two (256 mg) doses, in addition to standard therapy in line with the current temporary guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" of the Ministry of Health of Russian Federation. Standard therapy includes: * Baricitinib, p.o., 4 mg once daily for 7 days * Favipiravir, p.o., * for patients weighing <75 kg: 1600 mg twice daily on Day 1, then 600 mg twice daily from the 2nd to the 10th day; * for patients weighing ≥ 75 kg: 1800 mg twice daily on Day 1, then 800 mg twice daily from the 2nd to the 10th day; (Patients who have started etiotropic therapy with favipiravir or remdesivir prior to randomization will continue the initiated treatment.) * dexamethasone at doses of 4 - 20 mg / day or methylprednisolone at a dose of 1 mg / kg / intravenous injection every 12 hours. |
| Standard therapy | Active comparator | Drug: Standard therapyStandard therapy in line with the current temporary guidelines "Prevention, diagnosis and treatment of new coronavirus infection (COVID-19)" of the Ministry of Health of Russian Federation including: * Baricitinib, p.o., 4 mg once daily for 7 days * Favipiravir, p.o., * for patients weighing <75 kg: 1600 mg twice daily on Day 1, then 600 mg twice daily from the 2nd to the 10th day; * for patients weighing ≥ 75 kg: 1800 mg twice daily on Day 1, then 800 mg twice daily from the 2nd to the 10th day; (Patients who have started etiotropic therapy with favipiravir or remdesivir prior to randomization will continue the initiated treatment.) * dexamethasone at doses of 4 - 20 mg / day or methylprednisolone at a dose of 1 mg / kg / intravenous injection every 12 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed Informed Consent for participation in this study.
- Hospitalization (no more than 72 hours prior to randomization) with a diagnosis of coronavirus infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus (COVID-19).
- Moderate COVID-19. Moderate course of the disease is characterized by pneumonia on chest computed tomography (CT) (CT-1,2 stages) and body temperature > 38 °C, in combination with 1 or more of the following:
- The presence of signs of hyperinflammation. Signs of hyperinflammation are body temperature ≥ 38 °C for 2 days or more, combined with 1 or more of the following:
- Infection caused by the SARS-CoV-2 confirmed by of Polymerase chain reaction (PCR) test or an express test for antigen / antibodies to SARS-CoV-2 framework of the protocol.
Key exclusion criteria (34 listed)
- Hypersensitivity to olokizumab and / or other components of the study drug.
- Contraindications to favipiravir or glucocorticosteroids or Janus kinase inhibitors (baricitinib).
- Signs of a severe or extremely severe course of COVID-19, such as:
- Any of the following laboratory abnormalities:
- Severe renal failure: creatinine clearance < 30 ml / min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlokizumabOlokizumab, 128 mg, solution for subcutaneous administration 160 mg/mL | Drug | Olokizumab |
| Standard therapyStandard treatment including: * Baricitinib, 4 mg, film coated tablets * Favipiravir, 200 mg, film coated tablets * Dexamethasone IV or IM OR Methylprednisolone IV | Drug | Olokizumab, Standard therapy |
Primary outcome
Clinical recovery rate at day 7
Time frame: Up to day 7
Clinical recovery defined as score of 3 or less on a 10-point ordinal scale of clinical improvement. (From 0 "Healthy - no clinical manifestations, no viral RNA detected" to 10 "Death".) 7 days are counted from the day of the first administration / intake of study therapy / comparison therapy, depending on study group. Criteria for transition from category "4" to category "3" (criteria for potential discharge): body temperature < 37 °C; respiratory rate ≤ 20 per minute; SpO2 ≥ 95% without oxygen support, CRP < 10 mg/l. If any emergency procedures should be prescribed and/or signs of progression on CT are detected, the patient cannot be discharged/transferred to category "3". (In the case of the "rescue" therapy use or the development of clinical deterioration (an increase in the score by 1 point or more) during the follow-up period in a previously recovered patient, the patient is not considered as a "responder", i.e., who has reached the primary endpoint.)
8 secondary outcomes
Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 28, depending on study group
Time frame: Up to day 28
CRP normalization rate
Time frame: Up to Day 28
Ferritin normalization rate
Time frame: Up to Day 28
D-dimer normalization rate
Time frame: Up to Day 28
Mean CRP levels
Time frame: Up to Day 28
Mean ferritin levels
Time frame: Up to Day 28
Mean D-dimer levels
Time frame: Up to Day 28
Rate of prescribing other anti-inflammatory therapy regimens (rescue therapy), depending on study group
Time frame: Up to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olokizumab and Standard therapy in people with COVID-19, run by R-Pharm at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical recovery rate at day 7 (time frame: Up to day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.