Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

KK Women's and Children's Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Biological: SARS-CoV-2 Specific T Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04457726

COVID-T 2.0

Details and patient eligibility

About

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.

Full description

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 1 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 1 to 90 years
• 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

• Rapidly progressive disease with anticipated life-expectancy <72 hours
• Receiving steroid (>0.5mg/kg methylprednisolone equivalent)
• Pregnancy
• Breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Recipients with severe COVID-19

Experimental group

Description:

Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19.

Treatment:

Biological: SARS-CoV-2 Specific T Cells

Recipients with mild to moderate COVID-19

Experimental group

Description:

Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19.

Treatment:

Biological: SARS-CoV-2 Specific T Cells