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

NCT05982704 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-08-08

No results posted yet for this study

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

Interventions

DRUG

tixagevimab/cilgavimab 150+150 mg

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

DRUG

tixagevimab/cilgavimab 300+300 mg

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

DRUG

regdanvimab

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

Sponsors & Collaborators

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    collaborator OTHER

  • City Clinical Hospital No.52 of Moscow Healthcare Department

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2022-09-19
Completion
2023-11-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05982704 on ClinicalTrials.gov