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

Sponsor
Biocad (Industry)
Overall Status
Completed
CT.gov ID
NCT04397562
Collaborator
(none)
206
Enrollment
16
Locations
2
Arms
3.2
Actual Duration (Months)
12.9
Patients Per Site
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
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.

Study Design

Study Type:
Interventional
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 :
Apr 29, 2020
Actual Primary Completion Date :
Jul 3, 2020
Actual Study Completion Date :
Aug 3, 2020

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with sustained clinical recovery [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 [Day 30]

    7-Category Ordinal Scale of Clinical Status: Not hospitalized / Discharged Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, requiring supplemental oxygen Hospitalized, requiring non-invasive ventilation or high flow oxygen devices Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Death

  2. Proportion of patients transferred to the ICU [Day 60]

  3. Duration of fever [Day 60]

  4. Duration of hospitalization [Day 60]

  5. Change in ESR [Day 30]

  6. Change in serum CRP level [Day 30]

  7. Change in serum IL-6 level [Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Life expectancy < 24h, in the opinion of the investigator,

  2. Unlikely to remain at the investigational site beyond 48 hours

  3. Use of other monoclonal antibodies for COVID-19 treatment

  4. Current treatment with immunosuppressive agents (including corticosteroids)

  5. 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)

  6. Laboratory values:

  • ALT / AST > 10 ULN at screening

  • Platelets < 50х109/l at screening

  • Absolute Neutrophil Count < 1х109/l at screening

  1. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)

  2. Confirmed active tuberculosis

  3. History of allergic reaction to monoclonal antibodies

  4. Pregnancy or breastfeeding

  5. 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,

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1State Budgetary Healthcare Institution Kaluga region "Kaluga Regional Clinical Hospital"KalugaRussian Federation
2State Budget Institution of the Republic of Dagestan "Republican Clinical Hospital"MachačkalaRussian Federation
3A.N. Bakulev National Medical Research Center of Cardiovascular SurgeryMoscowRussian Federation
4City Clinical Hospital No. 40 of the Department of Health of the city of MoscowMoscowRussian Federation
5City Clinical Hospital No.52MoscowRussian Federation
6City Clinical Hospital № 15 named. O.M. FilatovMoscowRussian Federation
7City Clinical Hospital №1 named after N.I. Pirogov, Moscow City Health DepartmentMoscowRussian Federation
8Federal State Budgetary Institution "Central Clinical Hospital with Clinic", Office of the President of the Russian FederationMoscowRussian Federation
9I.M. Sechenov First Moscow State Medical University (Sechenov University)MoscowRussian Federation
10Pirogov Russian National Research Medical UniversityMoscowRussian Federation
11Railway clinical hospital named after N.A. SemashkoMoscowRussian Federation
12Almazov National Medical Research CentreSaint PetersburgRussian Federation
13Clinical Infectious Disease Hospital named after S.P. BotkinSaint PetersburgRussian Federation
14North-western State Medical University named after I.I.MechnikovSaint PetersburgRussian Federation
15Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian FederationUfaRussian Federation
16Federal 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)VladikavkazRussian Federation

Sponsors and Collaborators

  • Biocad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Biocad
ClinicalTrials.gov Identifier:
NCT04397562
Other Study ID Numbers:
  • BCD-089-4
First Posted:
May 21, 2020
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021