COVID-19Phase 2COMET-PACENCT05124210

Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19

A Phase 2 study testing Sotrovimab in people with COVID-19, run by GlaxoSmithKline at 2 sites in United States.

Terminated

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

Trial summary

This Phase 2b study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of sotrovimab in pediatric participants from birth to less than (<)18 years old with mild-to-moderate Coronavirus Disease-2019 (COVID-19) at high risk of disease progression. Read more about this study

Who is it for?: Ages 0 days to 18 years
Conditions the study is for: COVID-19
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: 8 participants
Where: 2 sitesUnited States
Study dates: 16 Dec 2021to 14 Jun 2023
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 0 days to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Participant must be 32 weeks estimated gestational age (EGA), day of life (DOL) 0 to <18 years of age inclusive, at either the time of participant's signed assent (if age-appropriate) or parent(s)/legally authorized representative signing the informed consent.
Participants with mild-moderate COVID-19.
Participants at risk of disease progression with at least one of the following criteria: Age <1 year; Diabetes mellitus; Genetic or metabolic diseases; Obesity ); Cardiovascular disease; Sickle cell disease; Pulmonary disease; Neurologic disease; Immunosuppressed ; Baseline medical complexity (gastrostomy- or jejunostomy-dependence, parenteral nutrition dependence, tracheostomy-dependence, Baseline oxygen requirement, use of Continuous positive airway pressure [CPAP]/ Bilevel positive airway pressure [BiPAP]/ventilator support).

Who cannot join

Participant is pregnant or breastfeeding.
Participant is currently hospitalized, or judged by the investigator as likely to require hospitalization in the next 24 hours, due to severe or critical COVID-19.
Multisystem inflammatory syndrome in children (MIS-C).
Prior, current, or planned future use of any of the following treatments during the study period: COVID-19 convalescent plasma, Monoclonal antibodies (mAbs) against Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (for example [e.g.], casirivimab/imdevimab), intravenous immunoglobulin (IVIG) for any indication, or dexamethasone specifically for treatment of COVID-19.
Current use of COVID-19 treatment (authorized, approved, or investigational).
The following exclusions related to use of an authorized or approved vaccine for SARS-CoV-2 are applicable:

Show all 11Show fewer

Receipt of any authorized or approved vaccine for SARS-CoV-2 within 48 hours prior to dosing.
Planned use of any authorized or approved vaccine for SARS-CoV-2 within 90 days of study drug administration per current Centers for Disease Control and Prevention (CDC) recommendations.
Receipt of any non-SARS-CoV-2 vaccines within 14 days (for non-live vaccines) or 28 days (for live vaccine) of screening.
Currently enrolled in another clinical study.
Infants <24 weeks of age: maternal receipt of IVIG, SARS-CoV-2-directed convalescent plasma or SARS-CoV-2-directed mAb(s) within 3 months prior to birth or within 5 half-lives of the investigational product (whichever is longer).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

GSK Investigational Site
Cullman, Alabama, 35055-1921
GSK Investigational Site
Mesa, Arizona, 85210

Other trials in United States

About this study

Official title: An Open-label, Non-comparator, Multicenter Study to Describe the Pharmacokinetics (PK), Pharmacodynamics (PD; Viral Load) and Safety Following a Single Intravenous or Intramuscular Dose of Sotrovimab in Pediatric Participants With Mild to Moderate COVID-19 at High Risk of Disease Progression

Conditions: COVID-19
Being tested: Sotrovimab
Keywords: COVID-19, Pharmacokinetics, Safety, Pharmacodynamics, Sotrovimab, Pediatric, Intravenous, Intramuscular
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
Sotrovimab will be administered.

Study groups in NCT05124210
Study group	Role	What they receive
Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years)	Experimental	Participants in the age group 6 to < 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1 Receives: Biological: Sotrovimab
Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years)	Experimental	Participants in the age group 12 to < 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1 Receives: Biological: Sotrovimab

What is being measured

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

Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods using Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Time to Reach Cmax (Tmax) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Clearance (CL) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Relative Bioavailability (F) Following Administration of Sotrovimab
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Measured: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
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 any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Measured: Up to Day 29
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36
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 any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Measured: Up to Week 36

Secondary outcomes (3)

Number of Participants With Progression of COVID-19 Through Day 29
Progression of COVID-19 is defined as need for attended medical visit (including the visit to a hospital emergency room for management of illness or hospitalization for acute management of illness) or escalation to higher level of medical care or death.
Measured: Up to Day 29
Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29
Severe and/or critical respiratory COVID-19 as manifested by requirement for supplemental oxygen through Day 29. For participants who required oxygen or respiratory support for premorbid conditions, disease progression was defined as any sustained (greater than [>]24 hours) increase in the level or method of oxygen support required.
Measured: Up to Day 29
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
The viral load change from baseline in nasal secretions was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) at Day 5, Day 8, and Day 11.
Measured: Baseline (Day 1), at Day 5, Day 8 and Day 11

Timeline

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

16 Dec 202114 Jun 2023

First posted17 Nov 2021
Study start16 Dec 2021
Primary completion14 Jun 2023
Study completion14 Jun 2023

Why it stopped: Decrease in in-vitro neutralization of study drug against circulating SARS-CoV-2 variants

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05124210
Sponsor's protocol ID: 215226
Acronym: COMET-PACE
Status last verified: Dec 2023
First submitted: 16 Nov 2021
Last updated: 3 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Non-comparator, Multicenter Study to Describe the Pharmacokinetics (PK), Pharmacodynamics (PD; Viral Load) and Safety Following a Single Intravenous or Intramuscular Dose of Sotrovimab in Pediatric Participants With Mild to Moderate COVID-19 at High Risk of Disease Progression
ClinicalTrials.gov ID: NCT05124210
Acronym / sponsor ID: COMET-PACE / 215226
Conditions: COVID-19
Keywords: COVID-19, Pharmacokinetics, Safety, Pharmacodynamics, Sotrovimab, Pediatric, Intravenous, Intramuscular
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Decrease in in-vitro neutralization of study drug against circulating SARS-CoV-2 variants
Enrolment: 8 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Vir Biotechnology, Inc.
Study start: 16 Dec 2021 (actual)
Primary completion: 14 Jun 2023 (actual)
Study completion: 14 Jun 2023 (actual)
First posted: 17 Nov 2021 (actual)
Results: Posted 3 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years)	Experimental	Biological: SotrovimabParticipants in the age group 6 to < 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years)	Experimental	Biological: SotrovimabParticipants in the age group 12 to < 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1

Who may qualify

Ages: 0 days to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Participant must be 32 weeks estimated gestational age (EGA), day of life (DOL) 0 to <18 years of age inclusive, at either the time of participant's signed assent (if age-appropriate) or parent(s)/legally authorized representative signing the informed consent.
Participants with mild-moderate COVID-19.
Participants at risk of disease progression with at least one of the following criteria: Age <1 year; Diabetes mellitus; Genetic or metabolic diseases; Obesity ); Cardiovascular disease; Sickle cell disease; Pulmonary disease; Neurologic disease; Immunosuppressed ; Baseline medical complexity (gastrostomy- or jejunostomy-dependence, parenteral nutrition dependence, tracheostomy-dependence, Baseline oxygen requirement, use of Continuous positive airway pressure [CPAP]/ Bilevel positive airway pressure [BiPAP]/ventilator support).

Key exclusion criteria (11 listed)

Participant is pregnant or breastfeeding.
Participant is currently hospitalized, or judged by the investigator as likely to require hospitalization in the next 24 hours, due to severe or critical COVID-19.
Multisystem inflammatory syndrome in children (MIS-C).
Prior, current, or planned future use of any of the following treatments during the study period: COVID-19 convalescent plasma, Monoclonal antibodies (mAbs) against Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (for example [e.g.], casirivimab/imdevimab), intravenous immunoglobulin (IVIG) for any indication, or dexamethasone specifically for treatment of COVID-19.
Current use of COVID-19 treatment (authorized, approved, or investigational).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SotrovimabSotrovimab will be administered.	Biological	Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years), Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years)

Primary outcome

Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab.
Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods using Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Time to Reach Cmax (Tmax) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.
Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Clearance (CL) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.
Relative Bioavailability (F) Following Administration of Sotrovimab
Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
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 any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36
Time frame: Up to Week 36
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 any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.

3 secondary outcomes

Number of Participants With Progression of COVID-19 Through Day 29
Time frame: Up to Day 29
Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29
Time frame: Up to Day 29
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Time frame: Baseline (Day 1), at Day 5, Day 8 and Day 11

Results and safety

Results posted to the registry on 3 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	3	1
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	5	5

Primary outcome: Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab

Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12. Geometric mean (Geometric Coefficient of Variation). Unit: Liter per day (L/day)

Measure	Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) n = 3	Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) n = 5
Value	0.05 (27.6)	0.10 (28.5)

Population analysed: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.

Primary outcome: Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab

Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12. Geometric mean (Geometric Coefficient of Variation). Unit: microgram per milliliter (µg/mL)

Measure	Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) n = 1	Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) n = 5
Value	342.96 (NA)	191.67 (29.45)

Population analysed: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Primary outcome: Time to Reach Cmax (Tmax) Following Administration of Sotrovimab

Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12. Median (Full Range). Unit: Day

Measure	Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) n = 1	Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) n = 5
Value	0.000 (NA to NA)	0.003 (0.00 to 0.02)

Primary outcome: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab

Time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12. Geometric mean (Geometric Coefficient of Variation). Unit: Day*microgram per milliliter (day*ug/mL)

Measure	Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years) n = 3	Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years) n = 5
Value	6023.0 (7.91)	4928.8 (24.4)

Population analysed: The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Upto Week 36. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0 of 5 (0%)	4 of 5 (80%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotrovimab in people with COVID-19, run by GlaxoSmithKline at 2 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 3 inclusion and 11 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 3 Jan 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?

Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab (time frame: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12). The study lists 10 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 NCT05124210.

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 Jan 2024.