NCT05124210: COMET-PACE

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

Terminated Phase 2 Results posted Last updated 3 January 2024

What this trial tests

Phase 2 trial testing Sotrovimab in COVID-19 in 8 participants. Terminated before completion.

Timeline

16 December 2021

Primary endpoint
14 June 2023

14 June 2023

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	16 December 2021
Primary completion	14 June 2023
Estimated completion	14 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• Sotrovimab — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 0 Days to 18, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab Primary · 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0.05	± 27.6
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0.10	± 28.5

Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab Primary · 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	342.96	± NA
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	191.67	± 29.45

Time to Reach Cmax (Tmax) Following Administration of Sotrovimab Primary · 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0.000	NA – NA
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0.003	0.00 – 0.02

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

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	6023.0	± 7.91
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	4928.8	± 24.4

Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab Primary · 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	37.5	± 16.1
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	43.6	± 22.0

Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab Primary · 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	1.42	± NA
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	5.49	± 22.08

Clearance (CL) Following Administration of Sotrovimab Primary · 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	42.62	± NA
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	96.58	± 30.44

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Primary · 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.

Participants with AE

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	1
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	2

Participants with SAE

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0

Participants with AESI

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0

Number of Participants With Progression of COVID-19 Through Day 29 Secondary · Up to 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0

Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29 Secondary · Up to 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.

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0

Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) Secondary · Baseline (Day 1), at Day 5, Day 8 and Day 11

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.

Baseline (Day 1)

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	5.085	± 0.2475
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	4.712	± 1.0668

Day 5

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	-1.270	± 2.6304
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	-2.160	± 1.4053

Day 8

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	-2.640	± 0.6930
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	-2.398	± 1.6272

Day 11

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	-3.305	± 0.2475
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	-2.870	± 1.1430

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 Primary · 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.

Participants with AE

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	1
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	4

Participants with SAE

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0

Participants with AESI

Group	Value	95% CI
Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)	0
Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Upto Week 36. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A: Sotrovimab Intravenous (IV) (6 to Less Than [<] 12 Years)

Serious: 0/3 (0%)

Deaths: 0/3

Cohort A: Sotrovimab Intravenous (IV) (12 to Less Than [<] 18 Years)

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (14 terms — click to expand)

Reaction	System	Cohort A: Sotrovimab Intra…	Cohort A: Sotrovimab Intra…
Hypoplastic left heart syndrome	Congenital, familial and genetic disorders	—	—
Hepatic fibrosis	Hepatobiliary disorders	—	—
Graft versus host disease	Immune system disorders	—	—
Gastroenteritis viral	Infections and infestations	—	—
Polyomavirus viraemia	Infections and infestations	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood creatinine increased	Investigations	—	—
Haematocrit increased	Investigations	—	—
Haemoglobin increased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Platelet count decreased	Investigations	—	—
White blood cell count decreased	Investigations	—	—

Data from ClinicalTrials.gov NCT05124210 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sotrovimab: First Approval.
   Heo YA. · · 2022 · cited 37× · PMID 35286623 · DOI 10.1007/s40265-022-01690-7
2. Keeping up with the COVID's-Could siRNA-based antivirals be a part of the answer?
   Forgham H, Kakinen A, Qiao R, Davis TP. · · 2022 · cited 16× · PMID 35941991 · DOI 10.1002/exp.20220012
3. Use of Sotrovimab in 14 Children with COVID-19: A Single-center Experience.
   Butzer SK, Habbig S, Mehler K, Haumann S, et al · · 2023 · cited 3× · PMID 36730080 · DOI 10.1097/inf.0000000000003781
4. Pharmacokinetics and Safety of Single-Dose Sotrovimab in High-Risk Children and Adolescents With Mild-to-Moderate COVID-19.
   Moore J, Austin D, Aylott A, Daniluk J, et al · · 2025 · PMID 40146813 · DOI 10.1093/jpids/piaf027