Coronavirus InfectionsPhase 4NCT05982704
Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19
A Phase 4 study testing tixagevimab/cilgavimab 150+150 mg, tixagevimab/cilgavimab 300+300 mg and regdanvimab in people with Coronavirus Infections, run by City Clinical Hospital No.52 of Moscow Healthcare Department at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- tixagevimab/cilgavimab 150+150 mg, tixagevimab/cilgavimab 300+300 mg and regdanvimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteRussia
- Study dates
- 18 Aug 2022to 1 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy of Viral Neutralizing Monoclonal Antibodies Tiksagevimab/Cilgavimab and Regdanvimab for Omicron Strain Dominance in Patients With COVID-19
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).
Read the 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 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.
- Conditions
- Coronavirus Infections
- Being tested
- tixagevimab/cilgavimab 150+150 mg, tixagevimab/cilgavimab 300+300 mg, regdanvimab
- Keywords
- viral neutralizing monoclonal antibodies, Tixagevimab/Cilgavimab, Regdanvimab, Omicron strain
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tixagevimab/cilgavimab 150+150 mgDrug
Also called EVUSHELD 150+150 mg
Administration of tixagevimab/cilgavimab at a dose of 150+150 mg in patients with moderate/severe coronavirus infection.
tixagevimab/cilgavimab 300+300 mgDrug
Also called EVUSHELD 300+300 mg
Administration of tixagevimab/cilgavimab at a dose of 300+300 mg in patients with moderate/severe coronavirus infection.
regdanvimabDrug
Also called REGKIRONA
Administration of regdanvimab at a dose of 40 mg/kg body weight in patients with moderate/severe coronavirus infection.
| Study group | Role | What they receive |
|---|---|---|
| tixagevimab/cilgavimab (Group 1) | Experimental | tixagevimab/cilgavimab at a dose of 150+150 mg Receives: Drug: tixagevimab/cilgavimab 150+150 mg |
| tixagevimab/cilgavimab (Group 2) | Experimental | tixagevimab/cilgavimab at a dose of 300+300 mg Receives: Drug: tixagevimab/cilgavimab 300+300 mg |
| regdanvimab group | Active comparator | regdanvimab at a dose of 40 mg/kg body weight Receives: Drug: regdanvimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: On the first (0) day ; on the fourth day (4)
Secondary outcomes (1)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start18 Aug 2022
- Primary completion19 Sep 2022
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- City Clinical Hospital No.52 of Moscow Healthcare Department
- Sponsor type
- University, hospital or other
- Collaborators
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Responsible party
- Principal investigator, Daria Fomina, City Clinical Hospital No.52 of Moscow Healthcare Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982704
- Sponsor's protocol ID
- 05вн/0922
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will not be shared with other researchers due to the conditions of the study
Publications
Fomina DS, Lebedkina MS, Iliukhina AA, Kovyrshina AV, Shelkov AY, Andreev SS, Chernov AA, Dolzhikova IV, Kruglova TS, Andrenova GV, Tukhvatulin AI, Shcheblyakov DV, Karaulov AV, Lysenko MA, Logunov DY, Gintsburg AL. Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period. Front Immunol. 2023 Oct 20;14:1259725. doi: 10.3389/fimmu.2023.1259725. eCollection 2023.
PubMed 37928549
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Viral Neutralizing Monoclonal Antibodies Tiksagevimab/Cilgavimab and Regdanvimab for Omicron Strain Dominance in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05982704
- Acronym / sponsor ID
- 05вн/0922
- Conditions
- Coronavirus Infections
- Keywords
- viral neutralizing monoclonal antibodies, Tixagevimab/Cilgavimab, Regdanvimab, Omicron strain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- City Clinical Hospital No.52 of Moscow Healthcare DepartmentUniversity, hospital or other
- Collaborators
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tixagevimab/cilgavimab (Group 1) | Experimental | Drug: tixagevimab/cilgavimab 150+150 mgtixagevimab/cilgavimab at a dose of 150+150 mg |
| tixagevimab/cilgavimab (Group 2) | Experimental | Drug: tixagevimab/cilgavimab 300+300 mgtixagevimab/cilgavimab at a dose of 300+300 mg |
| regdanvimab group | Active comparator | Drug: regdanvimabregdanvimab at a dose of 40 mg/kg body weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tixagevimab/cilgavimab 150+150 mgAlso: EVUSHELD 150+150 mgAdministration of tixagevimab/cilgavimab at a dose of 150+150 mg in patients with moderate/severe coronavirus infection. | Drug | tixagevimab/cilgavimab (Group 1) |
| tixagevimab/cilgavimab 300+300 mgAlso: EVUSHELD 300+300 mgAdministration of tixagevimab/cilgavimab at a dose of 300+300 mg in patients with moderate/severe coronavirus infection. | Drug | tixagevimab/cilgavimab (Group 2) |
| regdanvimabAlso: REGKIRONAAdministration of regdanvimab at a dose of 40 mg/kg body weight in patients with moderate/severe coronavirus infection. | Drug | regdanvimab group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 37928549Fomina DS, Lebedkina MS, Iliukhina AA, Kovyrshina AV, Shelkov AY, Andreev SS, Chernov AA, Dolzhikova IV, Kruglova TS, Andrenova GV, Tukhvatulin AI, Shcheblyakov DV, Karaulov AV, Lysenko MA, Logunov DY, Gintsburg AL. Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period. Front Immunol. 2023 Oct 20;14:1259725. doi: 10.3389/fimmu.2023.1259725. eCollection 2023.
- Individual participant dataSharing planned: No. Patient data will not be shared with other researchers due to the conditions of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tixagevimab/cilgavimab 150+150 mg, tixagevimab/cilgavimab 300+300 mg and regdanvimab in people with Coronavirus Infections, run by City Clinical Hospital No.52 of Moscow Healthcare Department at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.