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Monoclonal Antibodies

Sotrovimab for COVID-19 (COMET-PACE Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (end of infusion), day 5, 8 and 12, week 12
Awards & highlights

COMET-PACE Trial Summary

This trial will study how well sotrovimab works in young people with mild to moderate COVID-19 who are at risk of disease progression.

Eligible Conditions
  • COVID-19
  • Coronavirus

COMET-PACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (end of infusion), day 5, 8 and 12, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (end of infusion), day 5, 8 and 12, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab
Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab
+7 more
Secondary outcome measures
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29
Number of Participants With Progression of COVID-19 Through Day 29

COMET-PACE Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years)Experimental Treatment1 Intervention
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
Group II: Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years)Experimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotrovimab
2022
Completed Phase 3
~540

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,464 Total Patients Enrolled
22 Trials studying COVID-19
24,761 Patients Enrolled for COVID-19
Vir Biotechnology, Inc.Industry Sponsor
27 Previous Clinical Trials
13,250 Total Patients Enrolled
11 Trials studying COVID-19
8,770 Patients Enrolled for COVID-19
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,922 Total Patients Enrolled
2 Trials studying COVID-19
1,656 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are medical professionals currently seeking participants for this research endeavor?

"Per the clinicaltrials.gov database, this clinical trial is actively recruiting participants at present and was initially posted on December 16th 2021 with a recent update of November 4th 2022."

Answered by AI

Is the scope of this medical trial open to participants 55 and over?

"This clinical trial has stringent age requirements, with participants needing to be no younger than 0 days and no older than 18 years of age."

Answered by AI

What is the scope of participants for this clinical research?

"Affirmative. According to the data accessible on clinicaltrials.gov, this medical study, that was inaugurated on December 16th 2021 is currently recruiting participants. For completion of the trial 72 patients must be recruited from 7 distinct facilities."

Answered by AI

What medical conditions does Sotrovimab usually address?

"Sotrovimab is a medication utilized in cases of positive results from direct sarscov-2 viral testing, proclivity to progress towards severe Covid-19 and/or hospitalization, weight 40kg or more, as well as mild to moderate Covid-19."

Answered by AI

Are there multiple locations where this experimentation is taking place?

"At present, this medical trial is recruiting participants from 7 different sites. Locations include Idaho Falls, Houston and Cullman amongst other centres. To alleviate the burden of travel for patients that choose to enroll in the study, it's recommended they select a clinic near them."

Answered by AI

What criteria must a person fulfill to be eligible for this medical experiment?

"This research requires 72 subjects aged 0 Days to 18 years that have been confirmed with covid-19. Additionally, participants must meet one of the following criteria: be under 1 year old; suffer from diabetes mellitus; possess a genetic or metabolic disorder; obesity, cardiovascular disease, sickle cell anemia, pulmonary illness, neurological condition; immunocompromised state or baseline medical complexity (i.e. gastrostomy/jejunostomy dependence and usage of CPAP/BiPAP)."

Answered by AI

Are there any other investigations that have utilized Sotrovimab?

"Presently, there are 4 clinical trials involving Sotrovimab that are in progress with two of them currently at Phase 3. Most of the experiments for this medication are based in Pretoria, Gauteng; however, it is also possible to participate across 270 other locations worldwide."

Answered by AI

Has Sotrovimab gained the endorsement of the Food and Drug Administration?

"The safety profile of Sotrovimab was rated a 2, as it has been tested to some degree but there is no evidence demonstrating its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
2021. "Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05124210.
~2 spots leftby Apr 2025
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