NCT04397562

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

May 19, 2020

Last Update Submit

November 15, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (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.

    Day 14

Secondary Outcomes (7)

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

    Day 30

  • Proportion of patients transferred to the ICU

    Day 60

  • Duration of fever

    Day 60

  • Duration of hospitalization

    Day 60

  • Change in ESR

    Day 30

  • +2 more secondary outcomes

Study Arms (2)

LVL group

EXPERIMENTAL

Single subcutaneous administration of levilimab at a dose of 324 mg in combination with standard therapy

Drug: Levilimab

Placebo group

PLACEBO COMPARATOR

Single subcutaneous administration of placebo in combination with standard therapy

Drug: Placebo

Interventions

LevilimabDRUG

Levilimab 324 mg

LVL group
PlaceboDRUG

Placebo

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

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

Kaluga, Russia

Location

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

Makhachkala, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

City Clinical Hospital No.52

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

Pirogov Russian National Research Medical University

Moscow, Russia

Location

Railway clinical hospital named after N.A. Semashko

Moscow, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, Russia

Location

Clinical Infectious Disease Hospital named after S.P. Botkin

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Ufa, Russia

Location

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, Russia

Location

Related Publications (1)

  • 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.

    PMID: 34586459BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

levilimab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 21, 2020

Study Start

April 29, 2020

Primary Completion

July 3, 2020

Study Completion

August 3, 2020

Last Updated

November 18, 2021

Record last verified: 2020-11

Locations

RU(16)