Study of the Efficacy of Viral Neutralizing Monoclonal Antibodies Tiksagevimab/Cilgavimab and Regdanvimab for Omicron Strain Dominance in Patients With COVID-19
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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).
详细描述
Description of the intervention:
Hospitalized patients with moderate to severe coronavirus infection received three types of therapy: the tixagevimab/cilgavimab group (at a dose of 150+150 mg), the regdanvimab group (at a dose of 40 mg/kg body weight), and the tixagevimab/cilgavimab group (at a dose of 300+300 mg).
Further monitoring of the patient:
Screening period The screening period in the study begins with the signing of informed consent and lasts no longer than 24 hours (Visit 1, day 0) until the patient is included in the study (randomization).
Screening procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's signature of an informed consent form.
- •Men and women aged 18 years or older.
- •Confirmed diagnosis of new coronavirus infection COVID-
- •Appearance of COVID-19 symptoms within 7 days prior to study inclusion
- •Risk factors for COVID-19 progression and severity.
排除标准
- •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.
- •Need for oxygen therapy at the time of study inclusion.
- •Pregnancy.
研究组 & 干预措施
tixagevimab/cilgavimab (Group 1)
tixagevimab/cilgavimab at a dose of 150+150 mg
干预措施: tixagevimab/cilgavimab 150+150 mg (Drug)
tixagevimab/cilgavimab (Group 2)
tixagevimab/cilgavimab at a dose of 300+300 mg
干预措施: tixagevimab/cilgavimab 300+300 mg (Drug)
regdanvimab group
regdanvimab at a dose of 40 mg/kg body weight
干预措施: regdanvimab (Drug)
结局指标
主要结局
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)
时间窗: 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
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.
Viral load in nasopharyngeal swabs of patients by real-time PCR
时间窗: On the first (0) day ; on the fourth day (4)
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.
次要结局
- 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)
研究者
Daria Fomina
Allergologist-immunologist, Head of the c Center of Allergy and Immunology
City Clinical Hospital No.52 of Moscow Healthcare Department