Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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 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: - Obtaining informed consent. - Collection of medical history (including previous COVID-19 history + dates; COVID-19 vaccination information + dates and type of vaccine used; revaccination data; data about co-morbidities as risk factors, etc.). - Anthropometric data (height and weight) and demographic data. - Physical exam. - Collection of data on concomitant therapy. - Assessment of vital signs: measuring blood pressure, pulse and body temperature, pulse oximetry (SpO2) and respiratory rate. - Evaluation of SARS-CoV-2 virus test (smear PCR). - CT scan of the lungs. - Clinical blood count. - Biochemical blood count. - Complete urinalysis. - ECG. - Pregnancy test. - Verification of eligibility for inclusion/inclusion. - Decision of inclusion or exclusion of the patient. Core period visits (drug prescription): Visit 1 (Day 0-1) The conduct of Visit 1 takes place only after the patient has signed an informed consent form and the doctor-researcher has checked whether the inclusion/inclusion criteria are met) - Blood sampling to determine the level of antigen-specific antibodies to SARS-CoV-2 and viral neutralizing activity of patients' blood sera against different variants of SARS-CoV-2 virus before drug using - Sampling (nasal and oropharyngeal mucosa swabs) for PCR research or sequencing and viral load analysis - Injection of the testing drug - Interviewing the patient about subjective symptoms. - Assessment of vital signs (BP, pulse and body tº measurements, pulse oximetry (SpO2) and frequency of breathing. - ADR registration. - Blood sampling to determine the level of antigen-specific antibodies to SARS-CoV-2 and viral neutralizing activity of patients' sera against different variants of SARS-CoV-2 virus immediately after administration testing drugs (Tixaghevimab/cilgavimab or Regdanvimab). Visit 2 (Day 4) - Physical exam. - Collection of data on concomitant therapy. - Assessment of vital signs: blood pressure, pulse and body tº measurements, pulse oximetry (SpO2) and frequency of breathing. - Clinical blood count. - Biochemical blood count. - Sampling (nasal and oropharyngeal swabs) for PCR screening or sequencing and viral load analysis - Blood sampling to determine the level of antigen-specific antibodies to SARS-CoV-2 and viral neutralizing activity of patients' sera against different variants of SARS-CoV-2 virus immediately after administration of the testing drugs (Tixaghevimab/cilgavimab or Regdanvimab). - ADR registration. Procedures for an unscheduled safety visit In case of clinical or laboratory signs of adverse reactions associated with the testing drug, an unscheduled visit should be scheduled. In addition to the scheduled emergency procedures and/or examinations, information on the combination therapy and adverse events is collected at the visit. Minimum list of procedures for an unscheduled visit: - Interviewing the patient about subjective symptomatology. - Assessment of vital signs (BP, pulse and body tº measurements), pulse oximetry (SpO2) and frequency of breathing. - Clinical blood count (may be ordered by the examining physician) - Biochemical blood count (may be ordered by the examining physician) - Registration and evaluation of ADR. Reporting to pharmacovigilance authorities (Roszdravnadzor) and to the pharmacovigilance department of the marketing authorization holder. After the patient monitoring procedure, the efficacy and safety endpoints of the study drugs will be evaluated. The volume of patients included in the study was formed on the basis of available resources and laboratory test capabilities related to efficacy endpoints of the investigational drugs, as well as clinical experience on the prescription of investigational drugs in scientific publications on this topic. After estimating the distribution of the sample, in the case of a non-normal distribution will be used nonparametric statistical methods for data analysis in IBM SPSS Statistics V.22. Numeric variables Numerical variables will be presented as medians and interquartile ranges (IQRs). Quantitative variables will be compared using Mann-Whitney U test and/or one-way Kruskal-Wallis analysis of variance. Fisher's exact test or χ2-square test will be used for qualitative variables. For all tests, p-value < 0,05 is considered statistically significant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05982704
Study type Interventional
Source City Clinical Hospital No.52 of Moscow Healthcare Department
Contact
Status Active, not recruiting
Phase Phase 4
Start date August 18, 2022
Completion date November 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT04553575 - CoViD-19 Patient in Reims University Hospital in March to April 2020
Active, not recruiting NCT05033847 - Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above Phase 2
Active, not recruiting NCT05548439 - Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901a Phase 1
Completed NCT05046548 - This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 Phase 1/Phase 2
Active, not recruiting NCT05726084 - Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older Phase 2/Phase 3
Recruiting NCT05069129 - Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above Phase 1/Phase 2
Enrolling by invitation NCT05054075 - Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19 Phase 2
Recruiting NCT05599516 - Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial Phase 3
Completed NCT05047900 - The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community N/A
Completed NCT04420286 - Study of the Increase in ICU Beds Capacity During COVID-19 Pandemic in France
Completed NCT04424355 - Magnetic Resonance Imaging to Detect Signs of Viral Pneumonia in Patients With Coronavirus Infection.
Completed NCT05083039 - Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
Terminated NCT04409873 - Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19) Phase 2
Enrolling by invitation NCT04327349 - Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial N/A
Completed NCT04321278 - Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II) Phase 3
Recruiting NCT04327570 - In-depth Immunological Investigation of COVID-19.
Completed NCT04326309 - Audio Data Collection for Identification and Classification of Coughing
Recruiting NCT04322344 - Escin in Patients With Covid-19 Infection Phase 2/Phase 3
Completed NCT04328129 - Household Transmission Investigation Study for COVID-19 in Tropical Regions N/A
Completed NCT04323592 - Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome