Coronavirus Infections Clinical Trial
Official title:
Study of the Efficacy of Viral Neutralizing Monoclonal Antibodies Tiksagevimab/Cilgavimab and Regdanvimab for Omicron Strain Dominance in Patients With COVID-19
Verified date | August 2023 |
Source | City Clinical Hospital No.52 of Moscow Healthcare Department |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 82 |
Est. completion date | November 1, 2023 |
Est. primary completion date | September 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient's signature of an informed consent form. - Men and women aged 18 years or older. - Confirmed diagnosis of new coronavirus infection COVID-19. - Appearance of COVID-19 symptoms within 7 days prior to study inclusion - Risk factors for COVID-19 progression and severity. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Moscow City Clinical Hospital 52 | Moscow |
Lead Sponsor | Collaborator |
---|---|
City Clinical Hospital No.52 of Moscow Healthcare Department | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Adverse drug reaction | Any medically adverse event detected in a patient or clinical trial subject after the use of a drug, which may or may not have a causal relationship to its use.
The following information is given at the time of registration: exact time of occurrence and resolution of the disorder nature of the adverse event severity (mild, moderate, severe) Causal relationship to the study drug Whether the adverse event is serious Action taken (if ADR required treatment) outcome degree of expression |
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 |
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