Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19

NCT05982704 | Unknown Phase 4

• 1 other identifier: 05вн/0922
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Study hypothesis: the viral neutralizing monoclonal antibodies Tiksagevimab/Cilgavimab and Regdanvimab have high neutralizing activity against SARS-CoV-2 coronavirus, including Omicron strain, and may be effective in treating patients with moderate to severe COVID-19. Description of the clinical study: Administration of monoclonal antibodies as antiviral therapy to patients with covid-19 and further Assesment of viral neutralizing monoclonal antibodies (Tiksagevimab/Cilgavimab and Regdanvimab) efficacy for treatment of new coronavirus infection (COVID-19) in adult patients. Participation of patients of both sexes aged 18 years or older with COVID-19 of moderate to severe course, hospitalized. Inclusion of 82 patients in the study: 38 in the tixagevimab/cilgavimab group (at a dose of 150+150 mg), 24 patients in the regdanvimab group (at a dose of 40 mg/kg body weight) and 20 patients in the tixagevimab/cilgavimab group (at a dose of 300+300 mg).

Conditions

Coronavirus Infections

Keywords

viral neutralizing monoclonal antibodies; Tixagevimab/Cilgavimab; Regdanvimab; Omicron strain

Outcome Measures

Primary Outcomes (2)

• Viral neutralizing activity of patients' blood serum against different variants of SARS-CoV-2 virus (Wuhan and Omicron/ sublines BA.1, BA.2, BA.5)

  Preparation of serum samples for viral neutralizing activity analysis and determination of the level of viral neutralizing antibodies. Blood serum samples were inactivated at 56°C for 30 minutes in a solid-state thermostat. The neutralization reaction was performed in the constant dose-virus-serum dilution variant. Serum dilutions in DMEM culture medium with 2% inactivated fetal bovine serum were prepared, then 50 µl of serum dilutions were mixed with 100 TCID50 of SARS-CoV-2 virus (50 µl), incubated for 1 hour at 37°C and added to Vero E6 cells. The cells were incubated at 37ºC in 5% CO2, after 96 hours the cytopathic effect of the virus on the cell culture was recorded visually by assessing the disruption of the cell monolayer. The highest dilution of the tested serum, at which the cytopathic effect was suppressed, was taken as the viral neutralizing activity titer of the serum under study.

  On the first (0) day before the drug is administered; on the first day after the drug is administered; on the fourth day (4) after the drug is administered

• Viral load in nasopharyngeal swabs of patients by real-time PCR

  Virus production, determination of infectious titer, and confirmation by PCR. Virus accumulation was performed in Vero E6 cells in DMEM medium with 2% inactivated FBS. The culture fluid containing the virus was aliquoted, frozen, and stored at -80C. The infectious virus titer was determined on Vero E6 cells by TCID50 determination. TCID50 titer was calculated using the Reed-Muench method.

  On the first (0) day ; on the fourth day (4)

Secondary Outcomes (1)

• Adverse drug reaction

  On the first day after the drug is administered; on the fourth day after the drug is administered; an unscheduled visit in event of an ADR

Study Arms (3)

tixagevimab/cilgavimab (Group 1)

EXPERIMENTAL

tixagevimab/cilgavimab at a dose of 150+150 mg

Drug: tixagevimab/cilgavimab 150+150 mg

tixagevimab/cilgavimab (Group 2)

EXPERIMENTAL

tixagevimab/cilgavimab at a dose of 300+300 mg

Drug: tixagevimab/cilgavimab 300+300 mg

regdanvimab group

ACTIVE COMPARATOR

regdanvimab at a dose of 40 mg/kg body weight

Drug: regdanvimab

Interventions

tixagevimab/cilgavimab 150+150 mg DRUG

Administration of tixagevimab/cilgavimab at a dose of 150+150 mg in patients with moderate/severe coronavirus infection.

Also known as: EVUSHELD 150+150 mg

tixagevimab/cilgavimab (Group 1)

tixagevimab/cilgavimab 300+300 mg DRUG

Administration of tixagevimab/cilgavimab at a dose of 300+300 mg in patients with moderate/severe coronavirus infection.

Also known as: EVUSHELD 300+300 mg

tixagevimab/cilgavimab (Group 2)

regdanvimab DRUG

Administration of regdanvimab at a dose of 40 mg/kg body weight in patients with moderate/severe coronavirus infection.

Also known as: REGKIRONA

regdanvimab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's signature of an informed consent form.
• Men and women aged 18 years or older.
• Confirmed diagnosis of new coronavirus infection COVID-19.
• Risk factors for COVID-19 progression and severity.

You may not qualify if:

• Patients with hypersensitivity to the active substance or other excipients (for the "Evusheld" product group: histidine, histidine hydrochloride monohydrate, sucrose, polysorbate 80, methionine; for the "Regkiron" product group: L-histidine, L-histidine monohydrate, polysorbate 80, L-arginine monohydrate)
• Patients with a history of anaphylactic reactions to drugs of monoclonal antibody class.
• Pregnancy.

Sponsors & Collaborators

• City Clinical Hospital No.52 of Moscow Healthcare Department: lead
• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: collaborator

Study Sites (1)

Moscow City Clinical Hospital 52

Moscow, 123182, Russia

Location

Related Publications (1)

• Fomina DS, Lebedkina MS, Iliukhina AA, Kovyrshina AV, Shelkov AY, Andreev SS, Chernov AA, Dolzhikova IV, Kruglova TS, Andrenova GV, Tukhvatulin AI, Shcheblyakov DV, Karaulov AV, Lysenko MA, Logunov DY, Gintsburg AL. Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period. Front Immunol. 2023 Oct 20;14:1259725. doi: 10.3389/fimmu.2023.1259725. eCollection 2023.

  PMID: 37928549 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

tixagevimab; regdanvimab

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allergologist-immunologist, Head of the c Center of Allergy and Immunology

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 8, 2023
• Study Start: August 18, 2022
• Primary Completion: September 19, 2022
• Study Completion: November 1, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)