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COVID-19Phase 3CORONANCT04397562

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

A Phase 3 study testing Levilimab in people with COVID-19, run by Biocad at 16 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19. 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?
Levilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
16 sitesRussia
Study dates
29 Apr 2020to 3 Aug 2020
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 (subject; legally authorized representative) or signed conclusion of panel of independent medical doctors
  • Males and non-pregnant females aged 18 years or older at the IC date
  • Positive test for SARS-CoV2 nucleic acid (RNA) at the IC date
  • Admitted as inpatient to a hospital with radiologically confirmed pneumonia
  • Severe form of COVID-19.
  • Subjects meeting any of the following criteria:
Show all 14Show fewer
  • 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)

Who cannot join

  • Critical COVID-19. Subjects meeting any of the following:
  • Respiratory failure and requiring invasive mechanical ventilation (tracheal intubation)
  • Septic shock
  • Multiple organ failure
  • Life expectancy < 24h, in the opinion of the investigator,
  • Unlikely to remain at the investigational site beyond 48 hours
Show all 18Show fewer
  • Use of other monoclonal antibodies for COVID-19 treatment
  • Current treatment with immunosuppressive agents (including corticosteroids)
  • 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)
  • Laboratory values:
  • ALT / AST > 10 ULN at screening
  • Platelets < 50х109/l at screening
  • Absolute Neutrophil Count < 1х109/l at screening
  • Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
  • Confirmed active tuberculosis
  • History of allergic reaction to monoclonal antibodies
  • Pregnancy or breastfeeding
  • 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,

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Russia16 sites

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

    Kaluga

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

    Makhachkala

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

    Moscow

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

    Moscow

  • City Clinical Hospital No.52

    Moscow

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

    Moscow

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

    Moscow

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

    Moscow

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

    Moscow

  • Pirogov Russian National Research Medical University

    Moscow

  • Railway clinical hospital named after N.A. Semashko

    Moscow

  • Almazov National Medical Research Centre

    Saint Petersburg

  • Clinical Infectious Disease Hospital named after S.P. Botkin

    Saint Petersburg

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

    Saint Petersburg

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

    Ufa

  • 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)

    Vladikavkaz

Other trials in Russia

About this study

Official title: 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

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

Read the 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.

Conditions
COVID-19
Being tested
Levilimab, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevilimabDrug

    Levilimab 324 mg

  • PlaceboDrug

    Placebo

Study groups in NCT04397562
Study groupRoleWhat they receive
LVL groupExperimentalSingle subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy
Receives: Drug: Levilimab
Placebo groupPlacebo comparatorSingle subcutaneous administration of placebo in combination with standard therapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with sustained clinical recovery

    Sustained clinical recovery is defined as either an improvement of at least 2 categories relative to baseline on a 7-Category Ordinal Scale of Clinical Status or reaching categories "Discharged" / "Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care" at day 14.

    Measured: Day 14

Secondary outcomes (7)

  1. Proportion of patients reporting each category of 7-Category Ordinal Scale of Clinical Status

    7-Category Ordinal Scale of Clinical Status:

    1. Not hospitalized / Discharged
    2. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    3. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices
    6. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    7. Death

    Measured: Day 30

  2. Proportion of patients transferred to the ICU

    Measured: Day 60

  3. Duration of fever

    Measured: Day 60

  4. Duration of hospitalization

    Measured: Day 60

  5. Change in ESR

    Measured: Day 30

  6. Change in serum CRP level

    Measured: Day 30

  7. Change in serum IL-6 level

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start29 Apr 2020
  3. Primary completion3 Jul 2020
  4. Study completion3 Aug 2020

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04397562
Sponsor's protocol ID
BCD-089-4
Acronym
CORONA
Status last verified
Nov 2020
First submitted
19 May 2020
Last updated
18 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34586459

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levilimab in people with COVID-19, run by Biocad at 16 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 14 inclusion and 18 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: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of patients with sustained clinical recovery (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397562, which also lists 1 linked publication.

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 18 Nov 2021.

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