COVID-19NCT04351659
Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
An observational study of COVID-19, run by KK Women's and Children's Hospital at 2 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 for the treatment… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Blood donation from convalescent donor
- How many people
- 8 participants
- Where
- 2 sitesSingapore
- Study dates
- 14 Apr 2020to Sep 2022
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential donors are those who have recovered from COVID-19 and are willing to donate blood for other COVID-19 patients.
Who may be able to join
- Age 21 to 65
- Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past
- Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria
- Negative test for SARS-CoV-2 currently
Who cannot join
- Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
Lip Kun Tan
- 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 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 or specific treatment 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 aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.
A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.
- Conditions
- COVID-19
- Being tested
- Blood donation from convalescent donor
- Keywords
- SARS-CoV-2, Coronavirus disease
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood donation from convalescent donorOther
Donation of 1 unit of blood or leukapheresis
| Study group | Role | What they receive |
|---|---|---|
| Blood donors | Donors who had tested positive for SARS-CoV-2 in the past and have recovered from COVID-19 and are now suitable for blood donation. Receives: Other: Blood donation from convalescent donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
Success of SARS-CoV-2 specific T cell manufacturing is defined as production of >200,000 T cells per donor. The success rate will be summarized descriptively.
Measured: Two weeks (The expected duration of donor participation is 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start14 Apr 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wing Hang Leung, Principal investigator, KK Hospital, SingHealth, Duke-NUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351659
- Sponsor's protocol ID
- COVID-T 1.0
- Status last verified
- Mar 2022
- First submitted
- 16 Apr 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04351659
- Acronym / sponsor ID
- COVID-T 1.0
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Coronavirus disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore General Hospital, National University Hospital, Singapore
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Apr 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 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 or specific treatment 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 aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.
A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood donors | – | Other: Blood donation from convalescent donorDonors who had tested positive for SARS-CoV-2 in the past and have recovered from COVID-19 and are now suitable for blood donation. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential donors are those who have recovered from COVID-19 and are willing to donate blood for other COVID-19 patients.
Key inclusion criteria (4 listed)
- Age 21 to 65
- Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past
- Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria
- Negative test for SARS-CoV-2 currently
Key exclusion criteria (1 listed)
- Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.
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 |
|---|---|---|
| Blood donation from convalescent donorDonation of 1 unit of blood or leukapheresis | Other | Blood donors |
Primary outcome
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
Time frame: Two weeks (The expected duration of donor participation is 2 weeks)
Success of SARS-CoV-2 specific T cell manufacturing is defined as production of >200,000 T cells per donor. The success rate will be summarized descriptively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by KK Women's and Children's Hospital at 2 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 4 inclusion and 1 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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, childhoodcancer@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor (time frame: Two weeks (The expected duration of donor participation is 2 weeks)). 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 31 Mar 2022.