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Sotrovimab Injection for COVID-19 (COSMIC Trial)
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.
COSMIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOSMIC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COSMIC Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I do not have liver disease, except for Gilbert's syndrome or harmless gallstones.You regularly use illegal drugs.I have not received any vaccines in the last 48 hours.I was diagnosed with breast cancer in the last 10 years.Your blood pressure is not within the normal range during the screening.I have received COVID-19 convalescent plasma or a monoclonal antibody in the last 3 months.You are allergic to any ingredient in the study drug, or you had a severe allergic reaction after getting a COVID-19 vaccine.I only use medications allowed by my trial or approved by my doctor.I haven't had cancer, except for certain skin cancers, in the last 5 years.You have severe allergies to multiple drugs or have had bad reactions to corticosteroid creams.Your body mass index (BMI) is between 18 and 30.I am healthy based on recent medical exams, lab tests, and heart checks.You have tested positive for hepatitis B or hepatitis C in the past 3 months.I don't have conditions that prevent me from getting injections.I am able to understand and sign the consent form.I haven't taken any biologic agents in the last 3 months.I have a health condition that could affect how my body handles medication.I am between 18 and 65 years old.You have tested positive for HIV.You have been drinking alcohol regularly in the 6 months before the study.You have tested positive for drugs or alcohol before the study.You have taken more than 4 new medications in the last year before starting the study.To be included in the Japanese subgroup analysis, you must have Japanese ancestry, meaning all of your grandparents and parents are of Japanese descent.I started my COVID-19 vaccination but haven't finished all doses over 28 days ago.
- Group 1: Part C Cohort 7: Concentration 2 of sotrovimab
- Group 2: Part C Cohort 8: Concentration 2 of sotrovimab
- Group 3: Part A Cohort 2: Concentration 2 of sotrovimab
- Group 4: Part A Cohort 3: Concentration 2 of sotrovimab
- Group 5: Part A Cohort 1: Concentration 1 of sotrovimab
- Group 6: Part B Cohort 5: Concentration 1 of sotrovimab
- Group 7: Part B Cohort 6: Concentration 2 of sotrovimab
- Group 8: Part A Cohort 4: Concentration 2 of sotrovimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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