Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Standard of Care

    Other intervention

    Patients will receive standard of care for COVID-19.

  • SARS-CoV2-CTLS

    Biological/Vaccine

    Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: SARS-CoV-2 CTLS + Standard of CareExperimental treatment 2 interventions
Group B: Standard of Care OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

no adverse events will occur due to CTL infusion(s)

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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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
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