AzTrials
AzTrials

Covid19Phase 2COMET-PEAKNCT04779879

Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19

A Phase 2 study testing Sotrovimab (Gen1) and Sotrovimab (Gen2) in people with Covid19, run by Vir Biotechnology, Inc. at 31 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Covid19
What is being tested?
Sotrovimab (Gen1) and Sotrovimab (Gen2)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
31 sitesin 5 countries
Study dates
18 Feb 2021to 6 Apr 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
  • For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
  • Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from onset of symptoms

Who cannot join

  • Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
  • Symptoms consistent with severe COVID-19
  • Participants who, in the judgement of the investigator are likely to die in the next 7 days.
  • Severely immunocompromised participants
  • For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
  • For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
  • For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

United States18 sites

  • Investigative Site

    Anniston, Alabama, 36207

  • Investigative Site

    Bakersfield, California, 93301

  • Investigative Site

    Columbus, Georgia, 31904

  • Investigative Site

    Ft. Pierce, Florida, 34982

  • Investigative Site

    Gainesville, Florida, 32607

  • Investigative Site

    Hialeah, Florida, 33016

  • Investigative Site

    Houston, Texas, 77090

  • Investigative Site

    Miami, Florida, 33125

  • Investigative Site

    Miami, Florida, 33135

  • Investigative Site

    Miami, Florida, 33155

  • Investigative Site

    Miami, Florida, 33176

  • Investigative Site

    Northridge, California, 91325

  • Investigative Site

    Orlando, Florida, 32803

  • Investigative Site

    Pembroke Pines, Florida, 33024

  • Investigative Site

    Rockville, Maryland, 20850

  • Investigative Site

    Tampa, Florida, 33614

  • Investigative Site

    The Bronx, New York, 10456

  • Investigative Site

    Winfield, Illinois, 60190

Other trials in United States

Spain9 sites

  • Investigative Site

    Alicante, 03010

  • Investigative Site

    Barcelona, 08006

  • Investigative Site

    Centelles, 08540

  • Investigative Site

    Granada, 18014

  • Investigative Site

    La Roca del Vallès, 08430

  • Investigative Site

    Madrid, 28031

  • Investigative Site

    Madrid, 28040

  • Investigative Site

    Pozuelo de Alarcón, 28223

  • Investigative Site

    Vigo, 36312

Other trials in Spain

Canada2 sites

  • Investigative Site

    Sarnia, Ontario, N7T 4X3

  • Investigative Site

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Italy1 site

  • Investigative Site

    Milan, 20132

Other trials in Italy

South Korea1 site

  • Investigative Site

    Daejeon, 35015

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)

This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.

Conditions
Covid19
Being tested
Sotrovimab (Gen1), Sotrovimab (Gen2)
Keywords
SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sotrovimab (Gen1)Biological

    Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material

  • Sotrovimab (Gen2)Biological

    Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection

  • Sotrovimab (Gen2)Biological

    Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion

Study groups in NCT04779879
Study groupRoleWhat they receive
Sotrovimab (Gen1)Active comparatorPart A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material
Receives: Biological: Sotrovimab (Gen1); Biological: Sotrovimab (Gen2)
Sotrovimab (Gen2)Active comparatorPart B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection
Receives: Biological: Sotrovimab (Gen2)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

    Measured: Up to Day 29

  2. Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

    Measured: Up to Day 29

  3. Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29

    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

    Measured: Up to Day 29

  4. Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

    Measured: Up to Day 29

  5. Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8)

    AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal (NP) swab samples. Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.

    Measured: Day 1 to Day 8

  6. Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)

    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in NP swab samples. Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

    Measured: Day 1 to Day 8

Secondary outcomes (97)

  1. Part A: Number of Participants With Non-Serious AEs Through Week 12

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Adverse events which were not Serious were considered as Non-Serious adverse events.

    Measured: Up to Week 12

  2. Part A: Number of Participants With SAEs Through Week 24

    A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

    Measured: Up to Week 24

  3. Part A: Number of Participants With AESI Through Week 24

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion-related reactions (IRR) including hypersensitivity, events related to antibody-dependent enhancement, and events related to immunogenicity.

    Measured: Up to Week 24

  4. Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points

    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

    Measured: Days 1, 5, 11 and 85 (Week 12)

  5. Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24

    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

    Measured: Up to Week 24

  6. Part B: Number of Participants With All AEs and SAEs Through Day 29

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

    Measured: Up to Day 29

  7. Part B: Number of Participants With AESI Through Day 29

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity; injection site reactions (ISRs); events related to antibody-dependent enhancement; events related to immunogenicity.

    Measured: Up to Day 29

  8. Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29

    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

    Measured: Up to Day 29

  9. Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

    Measured: Up to Day 29

  10. Part C: Number of Participants With All AEs and SAEs Through Day 29

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events include both Serious and Other Adverse Events.

    Measured: Up to Day 29

  11. Part C: Number of Participants With AESI Through Day 29

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs were infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

    Measured: Up to Day 29

  12. Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29

    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented.

    Measured: Up to Day 29

  13. Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29

    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

    Measured: Up to Day 29

  14. Part B: Number of Participants With Non-Serious AEs Through Week 12

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

    Measured: Up to Week 12

  15. Part B: Number of Participants With SAEs Through Week 36

    A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

    Measured: Up to Week 36

  16. Part B: Number of Participants With AESI Through Week 36

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

    Measured: up to Week 36

  17. Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points

    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

    Measured: Days 1, 5, 11 and 85 (Week 12)

  18. Part B: Number of Participants With Disease Progression Events Through Week 36

    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

    Measured: Up to Week 36

  19. Part C: Number of Participants With Non-Serious AEs Through Week 12

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

    Measured: Up to Week 12

  20. Part C: Number of Participants With SAEs Through Week 36

    A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before.

    Measured: Up to Week 36

  21. Part C: Number of Participants With AESI Through Week 36

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs are infusion/injection-related reactions (IRR) including hypersensitivity reactions; injection site reactions (ISRs); events related to antibody-dependent enhancement, and events related to immunogenicity.

    Measured: Up to Week 36

  22. Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points

    Twelve-lead ECGs were recorded with the participant in a semi-supine position after being at rest for at least 10 minutes using an ECG machine. Clinically significant abnormal findings were determined as per clinical judgement by the investigator. Number of participants with clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented.

    Measured: Days 1, 5, 11 and 85 (Week 12)

  23. Part C: Number of Participants With Disease Progression Events Through Week 36

    AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, and considered to be not causally-related to the study agent or study procedures by the Investigator, were reported as a Disease-Related Events (DRE).

    Measured: Up to Week 36

  24. Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load

    SARS-CoV-2 viral load was based on saliva and nasal mid-turbinate swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the NEG and <2.08 results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline, Days 2, 5, 8, 11, 15, 22 and 29

  25. Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples

    Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29

  26. Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples

    Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline log10 viral load was defined as the non-missing assessment taken at Day 1 excluding the "NEG" and "<2.08" results. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29

  27. Part B: Percentage of Participants With Undetectable Viral Load

    Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

    Measured: Days 2, 3, 5, 8, 11, 15, 22 and 29

  28. Part C: Percentage of Participants With Undetectable Viral Load

    Viral load was measured by qRT-PCR from nasopharyngeal swab samples. Viral load (log10 copies/mL) values recorded as negative were considered as undetectable viral load. Percentage of participants with undetectable viral load have been presented. Percentage values are rounded off.

    Measured: Days 2, 3, 5, 8, 11, 15, 22 and 29

  29. Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)

    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

    Measured: Day 1 to Day 5

  30. Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)

    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.

    Measured: Day 1 to Day 11

  31. Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)

    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 5. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

    Measured: Day 1 to Day 5

  32. Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)

    AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 11. Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).

    Measured: Day 1 to Day 11

  33. Part B: Percentage of Participants With a Persistently High Viral Load at Day 8

    Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

    Measured: Day 8

  34. Part C: Percentage of Participants With a Persistently High Viral Load at Day 8

    Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage of participants with a persistently high viral load at Day 8 has been presented. Percentage values are rounded off.

    Measured: Day 8

  35. Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  36. Part B: Cmax of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  37. Part B: Cmax of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  38. Part C: Cmax of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  39. Part C: Cmax of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  40. Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  41. Part B: Clast of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  42. Part B: Clast of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  43. Part C: Clast of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  44. Part C: Clast of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  45. Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  46. Part B: Tmax of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  47. Part B: Tmax of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  48. Part C: Tmax of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  49. Part C: Tmax of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  50. Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  51. Part B: Tlast of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  52. Part B: Tlast of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  53. Part C: Tlast of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  54. Part C: Tlast of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  55. Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29

  56. Part B: AUCD1-29 of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

  57. Part B: AUCD1-29 of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

  58. Part C: AUCD1-29 of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

  59. Part C: AUCD1-29 of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

  60. Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  61. Part B: AUC(0-inf) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  62. Part B: AUC(0-inf) of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  63. Part C: AUC(0-inf) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  64. Part C: AUC(0-inf) of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  65. Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  66. Part B: AUClast of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  67. Part B: AUClast of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  68. Part C: AUClast of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  69. Part C: AUClast of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  70. Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  71. Part B: %AUCexp of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  72. Part B: %AUCexp of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  73. Part C: %AUCexp of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  74. Part C: %AUCexp of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  75. Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  76. Part B: t1/2 of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  77. Part B: t1/2 of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  78. Part C: t1/2 of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  79. Part C: t1/2 of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  80. Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  81. Part B: Vz of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  82. Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  83. Part C: Vz of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  84. Part C: Vz/F of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  85. Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  86. Part B: Vss of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  87. Part C: Vss of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  88. Part A: Clearance (CL) of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)

  89. Part B: CL of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  90. Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)

  91. Part C: CL of VIR-7831 After IV Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  92. Part C: CL/F of VIR-7831 After IM Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  93. Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C)

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab). Dose-normalized least square geometric mean ratio of AUCinf was derived based on collected assessments up to 169 (+/-7 days) for Part B- Sotrovimab Gen2: 500 mg IV arm, and up to 169 (+/-18 days) for Part C- Sotrovimab Gen2: 500 mg IV arm.

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  94. Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  95. Dose-normalized Least Square Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

  96. Dose-normalized Least Square Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)

  97. Dose-normalized Least Square Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B)

    Blood samples were collected at indicated time points for pharmacokinetic analysis of VIR-7831 (Sotrovimab).

    Measured: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start18 Feb 2021
  3. Primary completion20 Aug 2021
  4. Study completion6 Apr 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04779879
Sponsor's protocol ID
VIR-7831-5006
Other IDs
GSK Study 216912
Acronym
COMET-PEAK
Status last verified
Apr 2023
First submitted
1 Mar 2021
Last updated
3 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gupta A, Perez-Rodriguez MT, Gonzalez-Rojas Y, Ramgopal M, Free A, Han J, Moore J, Givens N, Yates PJ, Walker JT, Connolly MB, Schnell G, Imber V, Anselm R, Winograd L, Segal S, Harrison S, Skingsley A, Aldinger M, Peppercorn A, Moya J. Safety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild-to-Moderate COVID-19: A Randomized Clinical Trial. Drugs R D. 2025 Dec;25(4):353-365. doi: 10.1007/s40268-025-00529-2. Epub 2025 Nov 24.

    PubMed 41284195

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotrovimab (Gen1) and Sotrovimab (Gen2) in people with Covid19, run by Vir Biotechnology, Inc. at 31 sites in 5 countries.

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Spain, Canada, Italy, South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 (time frame: Up to Day 29). The study lists 6 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 NCT04779879, which also lists 2 linked publications.

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 3 May 2023.

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