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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.
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Inclusion and exclusion 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:
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
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 subjects 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:
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
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Central trial contact
Mitchell S Cairo, MD; Lauren Harrison, RN, MSN
Data sourced from clinicaltrials.gov
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