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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
Must not have
Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of SARS-CoV-2 CTLS
Patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, and I agree to use birth control during and 6 weeks after treatment.
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I am not listed for an organ transplant nor eligible to receive one.
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I do not have stage D heart failure or symptoms when resting.
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I have severe acute or extensive chronic graft-versus-host disease.
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I do not use a ventilator or oxygen at home due to chronic respiratory failure.
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My kidney function is normal or only mildly reduced.
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My liver tests are high, but I don't have Gilbert's syndrome.
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I do not have a family member who is a suitable match for a transplant.
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I have a low ability to carry out daily activities due to my health condition.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,782 Total Patients Enrolled
Medical College of WisconsinOTHER
635 Previous Clinical Trials
1,181,652 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,227,760 Total Patients Enrolled
New York Medical CollegeLead Sponsor
71 Previous Clinical Trials
6,104 Total Patients Enrolled
Mitchell S Cairo, MDStudy ChairNew York Medical College
14 Previous Clinical Trials
1,118 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
~0 spots leftby Dec 2024
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