Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19
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ClinicalTrials.gov Identifier: NCT05982704 |
Recruitment Status :
Active, not recruiting
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Infections | Drug: tixagevimab/cilgavimab 150+150 mg Drug: tixagevimab/cilgavimab 300+300 mg Drug: regdanvimab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Study of the Efficacy of Viral Neutralizing Monoclonal Antibodies Tiksagevimab/Cilgavimab and Regdanvimab for Omicron Strain Dominance in Patients With COVID-19 |
Actual Study Start Date : | August 18, 2022 |
Actual Primary Completion Date : | September 19, 2022 |
Estimated Study Completion Date : | November 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: tixagevimab/cilgavimab (Group 1)
tixagevimab/cilgavimab at a dose of 150+150 mg
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Drug: tixagevimab/cilgavimab 150+150 mg
Administration of tixagevimab/cilgavimab at a dose of 150+150 mg in patients with moderate/severe coronavirus infection.
Other Name: EVUSHELD 150+150 mg |
Experimental: tixagevimab/cilgavimab (Group 2)
tixagevimab/cilgavimab at a dose of 300+300 mg
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Drug: tixagevimab/cilgavimab 300+300 mg
Administration of tixagevimab/cilgavimab at a dose of 300+300 mg in patients with moderate/severe coronavirus infection.
Other Name: EVUSHELD 300+300 mg |
Active Comparator: regdanvimab group
regdanvimab at a dose of 40 mg/kg body weight
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Drug: regdanvimab
Administration of regdanvimab at a dose of 40 mg/kg body weight in patients with moderate/severe coronavirus infection.
Other Name: REGKIRONA |
- 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) [ Time Frame: 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 [ Time Frame: 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.
- Adverse drug reaction [ Time Frame: 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 ]
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05982704
Russian Federation | |
Moscow City Clinical Hospital 52 | |
Moscow, Russian Federation, 123182 |
Responsible Party: | Daria Fomina, Allergologist-immunologist, Head of the c Center of Allergy and Immunology, City Clinical Hospital No.52 of Moscow Healthcare Department |
ClinicalTrials.gov Identifier: | NCT05982704 |
Other Study ID Numbers: |
05вн/0922 |
First Posted: | August 8, 2023 Key Record Dates |
Last Update Posted: | August 8, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Patient data will not be shared with other researchers due to the conditions of the study |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
viral neutralizing monoclonal antibodies Tixagevimab/Cilgavimab Regdanvimab Omicron strain |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases |
Infections Cilgavimab and tixagevimab drug combination Antiviral Agents Anti-Infective Agents |