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

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptively Designed Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

NCT04397562•Biocad

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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%
+4 more criteria

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:
+8 more criteria

Locations (16)

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

Kaluga, Russia

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

Makhachkala, Russia

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

Moscow, Russia

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

Moscow, Russia

City Clinical Hospital No.52

Moscow, Russia

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

Moscow, Russia

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

Moscow, Russia

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

Moscow, Russia

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

Moscow, Russia

Pirogov Russian National Research Medical University

Moscow, Russia

Key Dates

Start Date

April 29, 2020

Primary Completion Date

July 3, 2020

Completion Date

August 3, 2020

Last Updated

November 18, 2021

Enrollment

206

ACTUAL participants

Conditions

COVID-19

Interventions

Levilimab

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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