Status:
UNKNOWN
Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19
Lead Sponsor:
City Clinical Hospital No.52 of Moscow Healthcare Department
Collaborating Sponsors:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions:
Coronavirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05982704
Start Date
August 18 2022
End Date
November 1 2023
Last Update
August 8 2023
Active Locations (1)
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1
Moscow City Clinical Hospital 52
Moscow, Russia, 123182