CORONA: A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19
Study Details
Study Description
Brief Summary
The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Proportion of patients transferred to the ICU [Day 60]
- Duration of fever [Day 60]
- Duration of hospitalization [Day 60]
- Change in ESR [Day 30]
- Change in serum CRP level [Day 30]
- Change in serum IL-6 level [Day 30]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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:
-
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:
- 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
-
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,
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | State Budgetary Healthcare Institution Kaluga region "Kaluga Regional Clinical Hospital" | Kaluga | Russian Federation | ||
| 2 | State Budget Institution of the Republic of Dagestan "Republican Clinical Hospital" | Machačkala | Russian Federation | ||
| 3 | A.N. Bakulev National Medical Research Center of Cardiovascular Surgery | Moscow | Russian Federation | ||
| 4 | City Clinical Hospital No. 40 of the Department of Health of the city of Moscow | Moscow | Russian Federation | ||
| 5 | City Clinical Hospital No.52 | Moscow | Russian Federation | ||
| 6 | City Clinical Hospital № 15 named. O.M. Filatov | Moscow | Russian Federation | ||
| 7 | City Clinical Hospital №1 named after N.I. Pirogov, Moscow City Health Department | Moscow | Russian Federation | ||
| 8 | Federal State Budgetary Institution "Central Clinical Hospital with Clinic", Office of the President of the Russian Federation | Moscow | Russian Federation | ||
| 9 | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow | Russian Federation | ||
| 10 | Pirogov Russian National Research Medical University | Moscow | Russian Federation | ||
| 11 | Railway clinical hospital named after N.A. Semashko | Moscow | Russian Federation | ||
| 12 | Almazov National Medical Research Centre | Saint Petersburg | Russian Federation | ||
| 13 | Clinical Infectious Disease Hospital named after S.P. Botkin | Saint Petersburg | Russian Federation | ||
| 14 | North-western State Medical University named after I.I.Mechnikov | Saint Petersburg | Russian Federation | ||
| 15 | Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation | Ufa | Russian Federation | ||
| 16 | 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- BCD-089-4