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New treatment option for Covid19
Official title SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
ClinicalTrials.gov ID: NCT04896606
What this study is testing
What is SARS-CoV2-CTLS?
SARS-CoV2-CTLS is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for covid19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The 2019 Severe Acute Respiratory Syndrome (SARS) is a global pandemic secondary to a novel coronavirus - SARS-CoV-2. The reported case-fatality ratio for SARS-CoV-2 in the United States is 1.8% with a current death toll of \>300,000 and climbing.4 There is no accepted standard of care or FDA approved therapies for treatment of COVID-19.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age ≥18 to 65 years. AND
- Proven infection with SARS-CoV-2, defined as detection of SARS-CoV-2 by RT-PCR from nasopharyngeal swab or lower respiratory tract specimen AND
- Hospitalized at the time of enrollment AND
- HLA Matched Family Related donor with recent SARS-CoV-2 infection is at least 10 days out from symptom onset. A negative result for COVID-19 by a...
- In Stage I or II of disease (mild or moderate) at the time of enrollment (Table 1) AND
You likely can't join if
- Stage III disease (severe) at the time of enrollment (see Table 1)
- Lack of an identified eligible HLA family related donor
- No high-risk comorbidities defined in the inclusion criteria (Section 5.1)
- Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of enrollment
- Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL Infusion
- Patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded
See the full eligibility criteria
- Age ≥18 to 65 years. AND
- Proven infection with SARS-CoV-2, defined as detection of SARS-CoV-2 by RT-PCR from nasopharyngeal swab or lower respiratory tract specimen AND
- Hospitalized at the time of enrollment AND
- HLA Matched Family Related donor with recent SARS-CoV-2 infection is at least 10 days out from symptom onset. A negative result for COVID-19 by a diagnostic test is not necessary to qualify the donor AND
- In Stage I or II of disease (mild or moderate) at the time of enrollment (Table 1) AND
- ONE of the following high-risk conditions:
- Chronic lung disease not requiring oxygen at home prior to admission (including but not limited to COPD, cystic fibrosis, asthma and sickle cell disease); Underlying heart disease (including hypertension); Patients with...
- Stage III disease (severe) at the time of enrollment (see Table 1)
- Lack of an identified eligible HLA family related donor
- No high-risk comorbidities defined in the inclusion criteria (Section 5.1)
- Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of enrollment
- Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL Infusion
- Patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded
- Patients with stage D heart failure and/or symptoms at rest are excluded
- Renal function: patients with eGFR or CrCl \<30 mL/min/1.73 m2 will be excluded from study entry.
- Liver function: Total bilirubin \> 2 mg/dl (unless Gilbert's syndrome) OR ALT/AST \> 5 x ULN
- Patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study
- Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤50%
- 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.
- Male people with female partners of childbearing age who are 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.
- Concurrent use of following medications is prohibited:
- Steroids (\>2 mg/kg/day prednisone equivalent); Immunotherapies within 4 weeks prior to CTL infusion including checkpoint blockade, ATG, Campath, CAR T cells, blinatumomab; Chemotherapy: Tyrosine kinase inhibitors and...
The study team makes the final eligibility decision.
Where it's taking place
- Valhalla, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valhalla, New York, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.