A Pilot Study of SARS-CoV-2 Specific Cytotoxic T Lymphocytes (SARS-CoV-2-CTLs) for Treatment of Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Overview
- Phase
- Phase 1
- Intervention
- Standard of Care
- Conditions
- Covid19
- Sponsor
- New York Medical College
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Incidence of adverse events
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
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. Virus specific cytotoxic T lymphocytes (CTLs) have become an important part of the treatment landscape for viral reactivation post hematopoietic and solid organ transplantation. Donor derived CTLs have been shown to be safe and effective against a variety of viruses including CMV, EBV, BK and adenovirus. We hypothesize that SARS-CoV-2 specific CTLs generated from a previously infected family donor will be safe and effective for treatment of COVID-19 in family members with mild to moderate disease.
Investigators
Eligibility Criteria
Inclusion 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 an acute myocardial infarction within the last 3 months will require cardiology clearance prior to enrollment; Diabetes mellitus (type I or II) ; Obesity (BMI ≥ 30); Immunosuppressed, based on investigator's assessment.
Exclusion Criteria
- •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
Arms & Interventions
SARS-CoV-2 CTLS + Standard of Care
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.
Intervention: Standard of Care
Standard of Care Only
Patients will NOT received COVID CTLs but will get standard of care.
Intervention: Standard of Care
SARS-CoV-2 CTLS + Standard of Care
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.
Intervention: SARS-CoV2-CTLS
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: 12 weeks
no adverse events will occur due to CTL infusion(s)