Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
NCT ID: NCT04457726
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2020-07-01
2022-12-31
Brief Summary
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Detailed Description
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The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections. Part Two of this project is to assess the safety and efficacy of these T cells in patients with COVID-19.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Recipients with severe COVID-19
Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19.
SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.
Recipients with mild to moderate COVID-19
Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19.
SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.
Interventions
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SARS-CoV-2 Specific T Cells
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.
Eligibility Criteria
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Inclusion Criteria
* Tested positive for SARS-CoV-2 \<72 hours prior to enrolment
* Predicted to have high chance of mortality:
Group 1: Severe disease, defined by one or more of the following:
* Dyspnea
* Respiratory frequency ≥ 30/min
* Blood oxygen saturation ≤ 93%
* Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
* Lung infiltrates \> 50% within 24 to 48 hours
* Respiratory failure
* Septic shock
* Multiple organ dysfunction or failure
Group 2: Mild to moderate disease, at high risk of progression to severe disease. For example,
* Age \> 65 years
* Chronic health conditions such as chronic lung disease, cardiovascular disease, diabetes mellitus, obesity, end-stage renal disease or liver disease
Exclusion Criteria
* Receiving steroid (\>0.5mg/kg methylprednisolone equivalent)
* Pregnancy
* Breastfeeding
1 Year
90 Years
ALL
No
Sponsors
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Duke-NUS Graduate Medical School
OTHER
National University Hospital, Singapore
OTHER
Singapore General Hospital
OTHER
Sengkang General Hospital
OTHER
Changi General Hospital
OTHER
KK Women's and Children's Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Wing Hang Leung
Role: PRINCIPAL_INVESTIGATOR
KK Hospital, SingHealth Duke NUS
Locations
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Changi General Hospital
Singapore, , Singapore
KK Women's and Children's Hospital
Singapore, , Singapore
National University Hospital
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Roshni Sadashiv Gokhale
Role: primary
Michaela Seng
Role: primary
Lip Kun Tan
Role: primary
Jiashen Loh
Role: primary
Yeh Ching Linn
Role: primary
Other Identifiers
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COVID-T 2.0
Identifier Type: -
Identifier Source: org_study_id
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