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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will receive standard of care for COVID-19.
Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.
New York Medical College
Valhalla, New York, United States
RECRUITINGNationwide Children's Hosptial
Columbus, Ohio, United States
NOT_YET_RECRUITINGChildren's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGMedical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGIncidence of adverse events
no adverse events will occur due to CTL infusion(s)
Time frame: 12 weeks
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