A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2020-08-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is multicenter, comparative, randomized, double-blind, placebo controlled clinical trial with adaptive design. Females and males, aged 18 years and older, admitted to hospital with severe COVID-19 pneumonia on SOC therapy will receive either levilimab 324 mg s/c or placebo s/c. In case of no clinical improvement is observed, investigator can administer a rescue therapy - open label LVL 324 mg s/c. The outcomes will be assessed up to day 60. Results of interim analysis of safety and efficacy data of first 60 enrolled subjects will be submitted for independent DMC review and decision about changes to the protocol.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LVL group

Single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy

Group Type EXPERIMENTAL

Levilimab

Intervention Type DRUG

Levilimab 324 mg

Placebo group

Single subcutaneous administration of placebo in combination with standard therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levilimab

Levilimab 324 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed informed consent (subject; legally authorized representative) or signed conclusion of panel of independent medical doctors
2. Males and non-pregnant females aged 18 years or older at the IC date
3. Positive test for SARS-CoV2 nucleic acid (RNA) at the IC date
4. Admitted as inpatient to a hospital with radiologically confirmed pneumonia
5. Severe form of COVID-19.
6. Subjects meeting any of the following criteria:

* Total respiratory rate \> 30 breaths per minute
* SpO2 ≤ 93%
* PaO2 /FiO2 ≤ 300 mmHg
* Chest imaging (X-ray, CT, US) showed lesion progression within 24-48 hours \>50%
* Decrease of consciousness level, Psychomotor agitation/irritability
* Hemodynamically unstable (systolic blood pressure \<90 mmHg or diastolic blood pressure \< 60 mmHg or urine output \< 20 ml/h)
* Arterial lactate \> 2 mmol/l
* qSOFA (quick sequential organ failure assessment score) \> 2. Subjects meeting three following criteria: Low blood pressure (SBP ≤ 100 mmHg); High respiratory rate (≥ 22 breaths/min); Altered mentation (Glasgow Coma Scale ≤ 14)

Exclusion Criteria

1. Critical COVID-19. Subjects meeting any of the following:

* Respiratory failure and requiring invasive mechanical ventilation (tracheal intubation)
* Septic shock
* Multiple organ failure
2. Life expectancy \< 24h, in the opinion of the investigator,
3. Unlikely to remain at the investigational site beyond 48 hours
4. Use of other monoclonal antibodies for COVID-19 treatment
5. Current treatment with immunosuppressive agents (including corticosteroids)
6. Participating in other drug clinical trials at the IC date or within 60 days after randomization (participation in COVID-19 anti-viral trials may be permitted if approved by Sponsor)
7. Laboratory values:

* ALT / AST \> 10 ULN at screening
* Platelets \< 50х109/l at screening
* Absolute Neutrophil Count \< 1х109/l at screening
8. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
9. Confirmed active tuberculosis
10. History of allergic reaction to monoclonal antibodies
11. Pregnancy or breastfeeding
12. Any illness or laboratory findings that, in the opinion of the study investigator, might pose an additional risk to the patient by their participation in the study,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Explore related publications, articles, or registry entries linked to this study.

Lomakin NV, Bakirov BA, Protsenko DN, Mazurov VI, Musaev GH, Moiseeva OM, Pasechnik ES, Popov VV, Smolyarchuk EA, Gordeev IG, Gilyarov MY, Fomina DS, Seleznev AI, Linkova YN, Dokukina EA, Eremeeva AV, Pukhtinskaia PS, Morozova MA, Zinkina-Orikhan AV, Lutckii AA. The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study. Inflamm Res. 2021 Dec;70(10-12):1233-1246. doi: 10.1007/s00011-021-01507-5. Epub 2021 Sep 29.

Reference Type BACKGROUND

PMID: 34586459 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BCD-089-4

Identifier Type: -

Identifier Source: org_study_id

A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

LVL group

Levilimab

Placebo group

Placebo

Interventions

Levilimab

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Biocad

Responsible Party

Locations

State Budgetary Healthcare Institution Kaluga region "Kaluga Regional Clinical Hospital"

State Budget Institution of the Republic of Dagestan "Republican Clinical Hospital"

A.N. Bakulev National Medical Research Center of Cardiovascular Surgery

City Clinical Hospital No. 40 of the Department of Health of the city of Moscow

City Clinical Hospital No.52

City Clinical Hospital № 15 named. O.M. Filatov

City Clinical Hospital №1 named after N.I. Pirogov, Moscow City Health Department

Federal State Budgetary Institution "Central Clinical Hospital with Clinic", Office of the President of the Russian Federation

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Pirogov Russian National Research Medical University

Railway clinical hospital named after N.A. Semashko

Almazov National Medical Research Centre

Clinical Infectious Disease Hospital named after S.P. Botkin

North-western State Medical University named after I.I.Mechnikov

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation

Federal State Budgetary Educational Institution of Higher Education "North Ossetian State Medical Academy" of the Ministry of Health of the Russian Federation (FSBEI HE SOGMA of the Ministry of Health of Russia)

Countries

References

Related Links

Other Identifiers

BCD-089-4