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Clinical 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. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.


Clinical Trial Description

The study has an adaptive design. Currently estimated sample size is 204 patients. After the enrollment of the first 100 patients (at most 130 screened), the enrollment will be suspended and an interim analysis will be carried out. After analyzing the data of the first 100 randomized patients, a decision will be made about the final sample size. 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


Related Conditions & MeSH terms


NCT number NCT05187793
Study type Interventional
Source R-Pharm
Contact
Status Recruiting
Phase Phase 3
Start date July 8, 2021
Completion date May 2022

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