SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
ConditionCovid19
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNew York Medical College
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard of Care
- SARS-CoV2-CTLS
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
New York Medical College
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Medical College of Wisconsin
Collaborator
Nationwide Children's Hospital
Collaborator
Source ClinicalTrials.gov