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Virus Therapy

SARS-CoV-2 CTLS for COVID-19

Phase 1 & 2

Recruiting

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Proven infection with SARS-CoV-2, defined as detection of SARS-CoV-2 by RT-PCR from nasopharyngeal swab or lower respiratory tract specimen

In Stage I or II of disease (mild or moderate) at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial is testing whether a person's previous infection with the coronavirus can help treat other family members with the virus.

Who is the study for?

This trial is for adults aged 18 to 65 with mild to moderate COVID-19 and certain high-risk conditions like chronic lung disease, heart disease, diabetes, obesity, or a weakened immune system. They must be hospitalized but not on oxygen at home prior to admission. A family member who's recently recovered from COVID-19 will donate T cells for the treatment.Check my eligibility

What is being tested?

The study is testing if virus-specific T cells (CTLs) from a family donor can treat COVID-19 in patients with mild to moderate symptoms. Participants will receive standard care plus these CTLs and their effectiveness and safety will be evaluated.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions related to immune therapies such as infusion reactions, increased risk of infections due to immunosuppression, or possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested positive for COVID-19 through a swab test.

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My condition is in the early or middle stage.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SARS-CoV-2 CTLS + Standard of CareExperimental Treatment2 Interventions

Patients will get family donor derived SARS-CoV-2 cytotoxic t-lymphocytes up to 5 times every 2 weeks along with Standard of care of COVID-19.

Group II: Standard of Care OnlyActive Control1 Intervention

Patients will NOT received COVID CTLs but will get standard of care.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,225 Total Patients Enrolled

Medical College of WisconsinOTHER

609 Previous Clinical Trials

1,162,533 Total Patients Enrolled

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,453 Total Patients Enrolled

Media Library

SARS-CoV2-CTLS (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04896606 — Phase 1 & 2

Coronavirus Research Study Groups: SARS-CoV-2 CTLS + Standard of Care, Standard of Care Only

Coronavirus Clinical Trial 2023: SARS-CoV2-CTLS Highlights & Side Effects. Trial Name: NCT04896606 — Phase 1 & 2

SARS-CoV2-CTLS (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04896606 — Phase 1 & 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease

2021. "SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04896606.

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