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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397562
Recruitment Status : Completed
First Posted : May 21, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Biocad

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Levilimab Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2020
Actual Primary Completion Date : July 3, 2020
Actual Study Completion Date : August 3, 2020

Arm Intervention/treatment
Experimental: LVL group
Single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy
Drug: Levilimab
Levilimab 324 mg

Placebo Comparator: Placebo group
Single subcutaneous administration of placebo in combination with standard therapy
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of patients with sustained clinical recovery [ Time Frame: Day 14 ]
    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.


Secondary Outcome Measures :
  1. Proportion of patients reporting each category of 7-Category Ordinal Scale of Clinical Status [ Time Frame: Day 30 ]

    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

  2. Proportion of patients transferred to the ICU [ Time Frame: Day 60 ]
  3. Duration of fever [ Time Frame: Day 60 ]
  4. Duration of hospitalization [ Time Frame: Day 60 ]
  5. Change in ESR [ Time Frame: Day 30 ]
  6. Change in serum CRP level [ Time Frame: Day 30 ]
  7. Change in serum IL-6 level [ Time Frame: Day 30 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397562


Locations
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Russian Federation
State Budgetary Healthcare Institution Kaluga region "Kaluga Regional Clinical Hospital"
Kaluga, Russian Federation
State Budget Institution of the Republic of Dagestan "Republican Clinical Hospital"
Machačkala, Russian Federation
A.N. Bakulev National Medical Research Center of Cardiovascular Surgery
Moscow, Russian Federation
City Clinical Hospital No. 40 of the Department of Health of the city of Moscow
Moscow, Russian Federation
City Clinical Hospital No.52
Moscow, Russian Federation
City Clinical Hospital № 15 named. O.M. Filatov
Moscow, Russian Federation
City Clinical Hospital №1 named after N.I. Pirogov, Moscow City Health Department
Moscow, Russian Federation
Federal State Budgetary Institution "Central Clinical Hospital with Clinic", Office of the President of the Russian Federation
Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russian Federation
Pirogov Russian National Research Medical University
Moscow, Russian Federation
Railway clinical hospital named after N.A. Semashko
Moscow, Russian Federation
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation
Clinical Infectious Disease Hospital named after S.P. Botkin
Saint Petersburg, Russian Federation
North-western State Medical University named after I.I.Mechnikov
Saint Petersburg, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation
Ufa, 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)
Vladikavkaz, Russian Federation
Sponsors and Collaborators
Biocad
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT04397562    
Other Study ID Numbers: BCD-089-4
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No