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SARS-CoV-2 CTLS for COVID-19
Study Summary
This trial is testing whether a person's previous infection with the coronavirus can help treat other family members with the virus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant, breastfeeding, and I agree to use birth control during and 6 weeks after treatment.I am not currently using certain medications or therapies as specified.I am not listed for an organ transplant nor eligible to receive one.I have a high-risk condition like lung disease, heart disease, diabetes, obesity, or I am immunosuppressed.I do not have stage D heart failure or symptoms when resting.I have tested positive for COVID-19 through a swab test.I have severe acute or extensive chronic graft-versus-host disease.I do not use a ventilator or oxygen at home due to chronic respiratory failure.I am a man and will use birth control during and 6 weeks after treatment.My donor had COVID-19 symptoms starting over 10 days ago but doesn't need a negative test now.My kidney function is normal or only mildly reduced.My liver tests are high, but I don't have Gilbert's syndrome.My condition is in the early or middle stage.I do not have a family member who is a suitable match for a transplant.My condition is classified as severe.I do not have any severe health conditions besides my current diagnosis.I received a donor lymphocyte infusion within the last 4 weeks.I am between 18 and 65 years old.I have a low ability to carry out daily activities due to my health condition.
- Group 1: SARS-CoV-2 CTLS + Standard of Care
- Group 2: Standard of Care Only
- 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
Are any additional volunteers being taken on for this research project?
"Correct. The clinical trial is recruiting as indicated on the clinicaltrials.gov website, which was initially published in September 2021 and revised most recently in January 2022. Approximately 50 participants are required from 4 different medical sites."
How many participants have enrolled in this empirical investigation?
"Affirmative. Clinicaltrials.gov's records show that the research project, initially made available on September 20th 2021, is actively recruiting patients. This trial hopes to find 50 individuals from 4 medical centres for participation."
Does this clinical trial have an age limit, and if so what is it?
"This clinical trial is seeking patients between the ages of 18 to 65. However, there are 138 studies for those below 18 and 905 dedicated to people above 65 years old."
How many locales in Canada are engaging with this experiment?
"Presently, this clinical study is running at 4 sites located in Milwaukee, Philadelphia and Columbus as well as one other undisclosed city. To reduce travel needs should you choose to partake in the trial, it would be beneficial to select a medical centre closest to your area of residence."
Are there eligibility criteria which would allow me to participate in this trial?
"This clinical trial is looking for 50 participants aged 18-65 who are presently suffering from Covid-19. Selected patients must meet the following criteria: hospitalization at time of enrollment, chronic respiratory disorders (e.g., COPD, cystic fibrosis), underlying heart disease (including hypertension); recent myocardial infarction requiring cardiology clearance; diabetes mellitus type I/II; obesity with a BMI ≥30; immunosuppression based on medical assessment; HLA matched family donor that has recently contracted SARS-CoV-2 and is 10 days out from symptom onset without needing to pass a negative COVID"
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