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Covid19Phase 1COSMICNCT05280717

Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)

A Phase 1 study testing sotrovimab in people with Covid19, run by Vir Biotechnology, Inc. at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
sotrovimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
10 sitesUnited States
Study dates
28 Mar 2022to 6 Nov 2023
Phase
Phase 1
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female participants, aged 18 to 65 years, inclusive.
  • Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • For Part C, inclusion in the Japanese subgroup analysis, a participant must meet all of the following criteria: Japanese ancestry, defined as being a descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents.
  • Body Mass Index (BMI) within the range of 18 to 30 kilogram per square meter (kg/m^2).
  • Capable of giving signed informed consent

Who cannot join

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Breast cancer within the past 10 years
  • Abnormal blood pressure at Screening.
  • Known hypersensitivity to any constituent present in the investigational product or history of severe hypersensitivity or anaphylaxis after receiving a COVID-19 vaccine
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
Show all 22Show fewer
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Use of any over the counter or prescription medications unless permitted by the protocol or approved by the Investigator in conjunction with the GSK medical monitor.
  • For Part A and Part B, any condition that would prohibit receipt of injections in the investigator's opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia.
  • Treatment with biologic agents (such as) within 3 months or 5 half-lives
  • Receipt of convalescent plasma from a recovered COVID-19 participant or anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) monoclonal antibody (mAb) within the last 3 months.
  • Receipt of any vaccine within 48 hours prior to enrollment.
  • Has received a SARS-CoV-2 vaccine but has not completed all doses in the series more than 28 days prior to Screening.
  • Exposure to more than 4 new chemical entities (e.g., investigational pharmaceuticals) within 12 months prior to the first dosing day.
  • Enrolment in any investigational vaccine study within the last 180 days or enrollment in any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives
  • Current enrolment or past participation in this clinical study.
  • A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to dosing.
  • Positive pre-study drug/alcohol screen.
  • Positive human immunodeficiency virus (HIV) antibody test.
  • History of regular alcohol consumption within 6 months prior to the study.
  • Regular use of known drugs of abuse.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Investigative Site

    Atlantis, Florida, 33462

  • Investigative Site

    Austin, Texas, 78745

  • Investigative Site

    Binghamton, New York, 13901

  • Investigative Site

    Edgewater, Florida, 32132

  • Investigative Site

    Houston, Texas, 77065

  • Investigative Site

    Medford, Oregon, 97504

  • Investigative Site

    Riverside, California, 92503

  • Investigative Site

    St Louis, Missouri, 63141

  • Investigative Site

    West Jordan, Utah, 84088

  • Investigative Site

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years

This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years. The study will be conducted in three parts (Part A, an optional Part B and Part C). Part B and Part C (cohort 2) were optional so they were not initiated. Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Conditions
Covid19
Being tested
sotrovimab
Keywords
COVID-19, Pharmacokinetics, Safety, Sotrovimab, Relative bioavailability, Healthy participants
Medical subject headings
COVID-19

What participants receive

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

  • sotrovimabBiological

    via IM injection

  • sotrovimabBiological

    via IM injection

  • sotrovimabBiological

    via IM injection

  • sotrovimabBiological

    via IM injection

  • sotrovimabBiological

    via IM injection

  • sotrovimabBiological

    via IV injection

  • sotrovimabBiological

    via IV infusion

Study groups in NCT05280717
Study groupRoleWhat they receive
Part A: Treatment arm 1- Sotrovimab 62.5 mg/mL (Dorsogluteal)ExperimentalParticipants will receive a single 500 milligram (mg) of 62.5 milligram per milliliter (mg/mL) sotrovimab administered via two injections intramuscularly into the dorsogluteal muscle on Day 1.
Receives: Biological: sotrovimab
Part A: Treatment arm 2- Sotrovimab 100 mg/mL (Dorsogluteal)ExperimentalParticipants will receive a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the dorsogluteal muscle on Day 1.
Receives: Biological: sotrovimab
Part A: Treatment arm 3- Sotrovimab 100 mg/mL (Anterolateral Thigh)ExperimentalParticipants will receive a single 500 mg of 100 mg/mL sotrovimab administered intramuscularly into the anterolateral thigh muscles on Day 1.
Receives: Biological: sotrovimab
Part A: Treatment arm 4- Sotrovimab 100 mg/mL (Deltoid)ExperimentalParticipants will receive a single 500 mg of 100 mg/mL sotrovimab administered two injections intramuscularly into the deltoid muscles on Day 1.
Receives: Biological: sotrovimab
Part B: SotrovimabExperimentalParticipants will receive 500 mg of 100 mg/mL and/or 62.5 mg/mL sotrovimab on Day 1.
Receives: Biological: sotrovimab
Part C: Cohort 1-SotrovimabExperimentalParticipants will receive a single 3000 mg of sotrovimab intravenous (IV) infusion over 60 minutes on Day 1.
Receives: Biological: sotrovimab
Part C: Cohort 2-SotrovimabExperimentalParticipants are planned to receive up to 3000 mg of sotrovimab intravenously on Day 1.
Receives: Biological: sotrovimab

What is being measured

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

  1. Part A (Treatment Arms 1 and 2): Area Under the Serum Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC[D1 to 29]) Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. Pharmacokinetic (PK) parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  2. Part A (Treatment Arms 1 and 2): Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  3. Part A (Treatment Arms 1 and 2): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and Common (>=5%) Non-serious Adverse Events (Non-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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

    Measured: Up to Day 29

  4. Part C (Cohorts 1 and 2): Number of Participants With SAEs, AESIs and Common (>=5%) Non-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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESI included hypersensitivity reaction based on a predefined list of terms.

    Measured: Up to Day 29

Secondary outcomes (14)

  1. Part A (Treatment Arms 1, 3 and 4): AUC(D1 to 29) Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  2. Part A (Treatment Arms 1, 3 and 4): Cmax Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  3. Part B: AUC(D1-29) Following Administration of Sotrovimab

    Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  4. Part B: Cmax Following Administration of Sotrovimab

    Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  5. Part C (Cohorts 1 and 2): AUC(D1-29) Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. PK parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  6. Part C (Cohorts 1 and 2): Cmax Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1. PK parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose

  7. Part A (Treatment Arms 1, 2, 3 and 4): Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) Following Administration of Sotrovimab at 3 Injection Sites

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab. PK parameters were calculated using standard non-compartmental analysis.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 (Week 24) post-dose

  8. Part B: AUCinf Following Administration of Sotrovimab at up to 2 Injection Sites

    Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 (Week 24) post-dose

  9. Part A (Treatment Arms 1, 2, 3 and 4): Serum Concentration Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

  10. Part B: Serum Concentration Following Administration of Sotrovimab

    Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of sotrovimab.

    Measured: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

  11. Part C: Serum Concentration Following Administration of Sotrovimab

    Blood samples were collected at indicated time points for pharmacokinetic analysis of sotrovimab in Cohort 1.

    Measured: Day 1: Pre-dose, end of infusion, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 140, 168 post-dose

  12. Part A (Treatment Arms 1, 2, 3 and 4): Number of Participants With SAEs, AESI and Common (>=5%) Non-SAEs Through Day 29 and Week 35

    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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

    Measured: Up to Day 29 and Up to Week 35

  13. Part B: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Day 29 and Week 35

    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. An SAE is defined as any untoward medical occurrence 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. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

    Measured: Up to Day 29 and Up to Week 35

  14. Part C: Number of Participants With SAEs, AESIs and Common (>=5%) Non-SAEs Through Week 35

    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. An SAE is defined as any untoward medical occurrence 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 which were not Serious were considered as non-serious adverse events. Number of participants who had common (>=5%) non-SAEs and SAEs are presented. AESIs included hypersensitivity reactions and injection site reactions based on a predefined list of terms.

    Measured: Up to Week 35

Timeline

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

  1. First posted15 Mar 2022
  2. Study start28 Mar 2022
  3. Primary completion5 Apr 2023
  4. Study completion6 Nov 2023

Why it stopped: Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280717
Sponsor's protocol ID
VIR-7831-5012
Other IDs
GSK Study 218128
Acronym
COSMIC
Status last verified
Apr 2024
First submitted
4 Mar 2022
Last updated
19 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sanchez-Pearson Y, Moore J, Daniluk J, Bhangu S, Parra S, El Zailik A, Sarkar P, Aylott A, Moyo F, Peppercorn A, Skingsley A. Safety, Tolerability and Pharmacokinetics of a High-Dose, Rapid-Infusion Monoclonal Antibody: Phase I Results for Intravenous Sotrovimab 3000 mg. Drugs R D. 2025 Dec;25(4):367-376. doi: 10.1007/s40268-025-00530-9. Epub 2025 Dec 1.

    PubMed 41324898

  • Moore J, Aylott A, Chen WH, Daniluk J, Hawes IA, Parra S, Sarkar P, Sanchez-Pearson Y, Turner M, Peppercorn A, Skingsley A. Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study. MAbs. 2025 Dec;17(1):2456467. doi: 10.1080/19420862.2025.2456467. Epub 2025 Jan 29.

    PubMed 39881564

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sotrovimab in people with Covid19, run by Vir Biotechnology, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 19 Sep 2024). 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 (Treatment Arms 1 and 2): Area Under the Serum Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC[D1 to 29]) Following Administration of Sotrovimab (time frame: Day 1: Pre-dose, 1, 2, 6 and 8 hours post-dose; Days 2, 3, 5, 8, 15 and 29 post-dose). The study lists 4 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 NCT05280717, 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 19 Sep 2024.

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