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OpenTrials
Completed

NCT Number: NCT04779879

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Sarnia, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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

Primary outcomes

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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).

  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)

    Time frame: Day 1 to Day 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.

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

    Time frame: Day 1 to Day 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).

Secondary outcomes

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

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

    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.

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

    Time frame: Up to 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).

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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).

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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).

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: up to 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.

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

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

    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.

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

    Time frame: Up to 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).

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

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

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

    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.

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

    Time frame: Up to 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).

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: Day 1 to Day 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.

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

    Time frame: Day 1 to Day 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.

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

    Time frame: Day 1 to Day 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).

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

    Time frame: Day 1 to Day 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).

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

  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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

    Time frame: 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)

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

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

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

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

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

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

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

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

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

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

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

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

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

  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)

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

    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.

  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)

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

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

  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)

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

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

  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)

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

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

  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)

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

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

Other outcomes

  1. Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

    Time frame: Up to Day 28

    Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  2. Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

    Time frame: Up to Day 28

    Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  3. Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

    Time frame: Up to Day 28

    Number of participants with presence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  4. Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

    Time frame: Up to Day 28

    Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  5. Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

    Time frame: Up to Day 28

    Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  6. Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831

    Time frame: Up to Day 28

    Number of participants with emergence of SARS-CoV-2 viral resistance mutants against VIR-7831 was planned to be evaluated. The results for this outcome measure will never be posted.

  7. Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody

    Time frame: Up to Week 24

    Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

  8. Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody

    Time frame: Up to Week 24

    Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

  9. Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody

    Time frame: Up to Week 24

    Number of participants with the presence of anti-VIR-7831 antibody was planned to be evaluated. The results for this outcome measure will never be posted.

  10. Part A: Titers of Anti-drug Antibody to VIR-7831

    Time frame: Up to Week 24

    Serum samples were planned to be collected for the determination of anti-drug antibody using a validated electrochemiluminescent (ECL) immunoassay. The results for this outcome measure will never be posted.

  11. Part B: Titers of Anti-drug Antibody to VIR-7831

    Time frame: Up to Week 24

    Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  12. Part C: Titers of Anti-drug Antibody to VIR-7831

    Time frame: Up to Week 24

    Serum samples were planned to be collected for the determination of anti-drug antibody using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  13. Part A: Number of Participants With the Presence of Anti-nucleocapsid (Anti-N), Anti-spike (Anti-S) and Anti-Receptor Binding Domain (Anti-RBD) SARS-CoV-2 Antibodies at Baseline

    Time frame: Baseline (Day 1)

    Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  14. Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

    Time frame: Baseline (Day 1)

    Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  15. Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

    Time frame: Baseline (Day 1)

    Number of participants with the presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  16. Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

    Time frame: Baseline (Day 1)

    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  17. Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

    Time frame: Baseline (Day 1)

    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  18. Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline

    Time frame: Baseline (Day 1)

    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  19. Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29

    Time frame: Day 29

    Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  20. Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29

    Time frame: Day 29

    Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  21. Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29

    Time frame: Day 29

    Number of participants with the presence of Anti-N SARS-CoV-2 antibodies were planned to be evaluated. The results for this outcome measure will never be posted.

  22. Part A: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29

    Time frame: Day 29

    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  23. Part B: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29

    Time frame: Day 29

    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

  24. Part C: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29

    Time frame: Day 29

    Serum samples were planned to be collected for the determination of anti-drug antibodies using a validated ECL immunoassay. The results for this outcome measure will never be posted.

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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)

Acronym: COMET-PEAK

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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