COVID-19Phase 1/2NCT04457726
Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
A Phase 1/2 study testing SARS-CoV-2 Specific T Cells in people with COVID-19, run by KK Women's and Children's Hospital at 5 sites in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- SARS-CoV-2 Specific T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesSingapore
- Study dates
- 1 Jul 2020to Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Rapidly progressive disease with anticipated life-expectancy <72 hours
- Receiving steroid (>0.5mg/kg methylprednisolone equivalent)
- Pregnancy
- Breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Singapore5 sites, 5 recruiting
- Recruiting
Changi General Hospital
Singapore
Roshni Sadashiv Gokhale
- Recruiting
KK Women's and Children's Hospital
Singapore
Michaela Seng
- Recruiting
National University Hospital
Singapore
Lip Kun Tan
- Recruiting
Sengkang General Hospital
Singapore
Jiashen Loh
- Recruiting
Singapore General Hospital
Singapore
Yeh Ching Linn
About this study
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.
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 Specific T Cells
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Specific T CellsBiological
Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Recipients with severe COVID-19 | Experimental | Recipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19. Receives: Biological: SARS-CoV-2 Specific T Cells |
| Recipients with mild to moderate COVID-19 | Experimental | Recipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19. Receives: Biological: SARS-CoV-2 Specific T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities
Dose-limiting toxicities are defined as >Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.
Measured: till Day 28 after infusion of SARS-CoV-2 specific T cells
Secondary outcomes (6)
National Early Warning Score (NEWS)
Measured by change in daily NEWS score after infusion of SARS-CoV-2 specific T cells
Measured: one month
Time to improvement by one category on a WHO ordinal scale
Measured by time-to-improvement by one category on a WHO ordinal scale after infusion of SARS-CoV-2 specific T cells
Measured: one month
Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells
Measured by time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells
Measured: two months
Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation
Measured by the duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood
Measured: two months
Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion
Measured by the time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion
Measured: two months
Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells
Measured by the proportion of recipients surviving at 3 months after infusion of SARS-CoV-2 specific T cells
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Duke-NUS Graduate Medical School, National University Hospital, Singapore, Singapore General Hospital, Sengkang General Hospital, Changi General Hospital
- Responsible party
- Sponsor
- Investigators
- Wing Hang Leung, Principal investigator, KK Hospital, SingHealth Duke NUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457726
- Sponsor's protocol ID
- COVID-T 2.0
- Status last verified
- Jun 2020
- First submitted
- 2 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04457726
- Acronym / sponsor ID
- COVID-T 2.0
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Duke-NUS Graduate Medical School, National University Hospital, Singapore, Singapore General Hospital, Sengkang General Hospital, Changi General Hospital
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipients with severe COVID-19 | Experimental | Biological: SARS-CoV-2 Specific T CellsRecipients who are confirmed positive by SARS-CoV-2 testing and have severe COVID-19. |
| Recipients with mild to moderate COVID-19 | Experimental | Biological: SARS-CoV-2 Specific T CellsRecipients who are confirmed positive by SARS-CoV-2 testing and have mild to moderate COVID-19. |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Age 1 to 90 years
- Tested positive for SARS-CoV-2 <72 hours prior to enrolment
- Predicted to have high chance of mortality:
- Dyspnea
- Respiratory frequency ≥ 30/min
Key exclusion criteria (4 listed)
- Rapidly progressive disease with anticipated life-expectancy <72 hours
- Receiving steroid (>0.5mg/kg methylprednisolone equivalent)
- Pregnancy
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 Specific T CellsEligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously. | Biological | Recipients with mild to moderate COVID-19, Recipients with severe COVID-19 |
Primary outcome
Dose-Limiting Toxicities
Time frame: till Day 28 after infusion of SARS-CoV-2 specific T cells
Dose-limiting toxicities are defined as >Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.
6 secondary outcomes
National Early Warning Score (NEWS)
Time frame: one month
Time to improvement by one category on a WHO ordinal scale
Time frame: one month
Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells
Time frame: two months
Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation
Time frame: two months
Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion
Time frame: two months
Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Hang Leung principal investigator
KK Hospital, SingHealth Duke NUS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SARS-CoV-2 Specific T Cells in people with COVID-19, run by KK Women's and Children's Hospital at 5 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michaela Seng (82487085, bmtct@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (time frame: till Day 28 after infusion of SARS-CoV-2 specific T cells). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.