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Sotrovimab Injection for COVID-19 (COSMIC Trial)

Phase 1
Recruiting
Research Sponsored by Vir Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Capable of giving signed informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 35
Awards & highlights

COSMIC Trial Summary

This trial will test two different concentrations of sotrovimab injections to see which is more effective and has fewer side effects. The study will be conducted in two parts with male and female participants aged 18 to 65 years old.

Who is the study for?
Healthy adults aged 18-65 with a BMI of 18-30 kg/m^2 can join this study. They must not have significant health issues, drug allergies, or a history of severe reactions to COVID-19 vaccines. Participants cannot be on certain medications or have had recent treatments that could affect the trial results.Check my eligibility
What is being tested?
The COSMIC trial is testing how the body absorbs sotrovimab injections at different concentrations and sites. It's divided into three parts and includes healthy participants, focusing also on those of Japanese ancestry for specific analysis.See study design
What are the potential side effects?
While specific side effects are not listed, sotrovimab may cause reactions at injection sites, allergic responses, and other common medication-related side effects which will be monitored for safety and tolerability.

COSMIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy based on recent medical exams, lab tests, and heart checks.
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I am able to understand and sign the consent form.
Select...
I am between 18 and 65 years old.

COSMIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29
+1 more
Secondary outcome measures
Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
+14 more

COSMIC Trial Design

8Treatment groups
Experimental Treatment
Group I: Part C Cohort 8: Concentration 2 of sotrovimabExperimental Treatment1 Intervention
administered by IV infusion
Group II: Part C Cohort 7: Concentration 2 of sotrovimabExperimental Treatment1 Intervention
administered by intravenous (IV) infusion
Group III: Part B Cohort 6: Concentration 2 of sotrovimabExperimental Treatment1 Intervention
administered at potential injection site 1,2,3 or other
Group IV: Part B Cohort 5: Concentration 1 of sotrovimabExperimental Treatment1 Intervention
administered at potential injection site 1,2,3 or other
Group V: Part A Cohort 4: Concentration 2 of sotrovimabExperimental Treatment1 Intervention
administered at injection site 3
Group VI: Part A Cohort 3: Concentration 2 of sotrovimabExperimental Treatment1 Intervention
administered at injection site 2
Group VII: Part A Cohort 2: Concentration 2 of sotrovimabExperimental Treatment1 Intervention
administered at injection site 1
Group VIII: Part A Cohort 1: Concentration 1 of sotrovimabExperimental Treatment1 Intervention
administered at injection site 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sotrovimab
2021
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vir Biotechnology, Inc.Lead Sponsor
27 Previous Clinical Trials
12,754 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,748 Previous Clinical Trials
8,067,008 Total Patients Enrolled

Media Library

sotrovimab Clinical Trial Eligibility Overview. Trial Name: NCT05280717 — Phase 1
Coronavirus Research Study Groups: Part C Cohort 7: Concentration 2 of sotrovimab, Part C Cohort 8: Concentration 2 of sotrovimab, Part A Cohort 2: Concentration 2 of sotrovimab, Part A Cohort 3: Concentration 2 of sotrovimab, Part A Cohort 1: Concentration 1 of sotrovimab, Part B Cohort 5: Concentration 1 of sotrovimab, Part B Cohort 6: Concentration 2 of sotrovimab, Part A Cohort 4: Concentration 2 of sotrovimab
Coronavirus Clinical Trial 2023: sotrovimab Highlights & Side Effects. Trial Name: NCT05280717 — Phase 1
sotrovimab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280717 — Phase 1

Frequently Asked Questions

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

Is enrollment still in progress for this medical study?

"Affirmative. According to clinicaltrials.gov, the medical trial is still accepting participants since its original posting on March 28th 2022 and has been recently updated on November 2nd 2022. A total of 504 patients are needed from 10 different medical centres for this study."

Answered by AI

Is the cutoff age for this trial below 30 years old?

"As per the specified criteria for this medical experiment, patients must be aged 18-65. 138 studies are available to those under the age of majority and 905 trials have been designed with seniors in mind."

Answered by AI

What is the geographic distribution of this study's sites?

"Currently, 10 locations are hosting this trial. These spots include Saint Louis, Austin and Riverside as well as 7 other cities. It is highly encouraged to select the closest clinic in order to minimize commuting challenges should you choose to participate."

Answered by AI

Do I meet the eligibility criteria for this research trial?

"This medical trial seeks 504 individuals of ages 18-65 who have contracted covid19. Criteria for inclusion are as such: gender no barring; a healthy lifestyle, per medical examination and lab results; Japanese heritage with 4 ethnic grandparents and 2 parents being Japanese nationals; BMI between 18-30 kg/m^2; willing to sign an informed consent document."

Answered by AI

Has sotrovimab been officially sanctioned by the FDA?

"There is limited evidence to suggest the safety and efficacy of sotrovimab, so it was given a score of 1."

Answered by AI

How many participants are presently being treated as part of this experiment?

"Affirmative. The publically available data on clinicaltrials.gov indicates that this medical study is currently in recruitment mode, with the first posting taking place on March 28th 2022 and its latest update released November 2nd of the same year. This trial needs to recruit 504 participants at 10 different sites."

Answered by AI
~168 spots leftby Mar 2025