COVID-19NCT05675826
The Impact of Donor COVID-19 Infection Status on the Recipient in Allo-HSCT
An observational study of COVID-19 and Hematopoietic Stem Cell Transplantation, run by Chen Suning at 1 site in China.
Trial summary
This study was conducted to observe whether COVID-19 can be transmitted through stem cell transplantation and whether COVID-19-positive donors have an effect on early hematopoietic reconstitution and immune reconstitution in the recipients. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- COVID-19, Hematopoietic Stem Cell Transplantation
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2022to 30 Apr 2023
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population wil be patients who underwent allogeneic HSCT during the COVID19 epidemic.
Who may be able to join
- Age between 16 and 65 years old.
- History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma).
- Allogeneic hematopoietic stem cell transplantation perform during the COVID19 pandemic.
Who cannot join
- Hematological diseases, other than hematological malignancies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Suning Chen, PhD, +8613814881746, chensuning@sina.com
About this study
Official title: The Impact of Donor COVID-19 Infection Status on the Recipient in Allogeneic Hematopoietic Stem Cell Transplantation.
This study was conducted to observe whether COVID-19 can be transmitted through stem cell transplantation and whether COVID-19-positive donors have an effect on early hematopoietic reconstitution and immune reconstitution in the recipients.
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced COVID-19 infections are showing an explosive increase in China starting in late 2022. SARS-CoV-2 infections are characterized by an initial viral replication followed by an inflammatory phase with lymphocyte depletion in severe patients.
Past studies have shown that SARS-CoV -2 is detectable in the blood of 8%-15% of patients and that viremia occurs in the first 2-3 days after the onset of symptoms. EBMT, WMDA and other organizations have suggested that COVID-19 positive donors must be excluded or delayed from donation for safety reasons.
However, there have not been any reports of transmission from donor to recipient in blood product transfusion or cell therapy. In the only reported cases of allogeneic HSCT from SARS-CoV-2 positive donors, there was also no evidence of recipient infection from the graft.
In the current situation where the vast majority of people are infected with COVID-19 in the short term, many patients, such as those with leukemia, are in urgent need of transplantation due to the aggressive， hard-to-control，underlying disease. The investigators established this observational clinical trial to investigate whether COVID-19 is transmitted through stem cells and whether COVID-19 positive donors have an impact on early hematopoietic reconstitution and immune reconstitution in recipients.
- Conditions
- COVID-19, Hematopoietic Stem Cell Transplantation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Donor infected with covid19 | This includes donors who have been infected or are infected with COVID19 at the time of hematopoietic stem cell collection. | |
| Donor not infected with covid | Including donors not yet infected with COVID19 at the time of hematopoietic stem cell collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematopoietic reconstitution
To compare the differences in the time of hematopoietic reconstitution between the two groups after transplantation.
Measured: 1 month after enrollment of the last case
Secondary outcomes (3)
Infection of COVID19
To compare the rate of early COVID19 infection between the two groups as well as the rate of severe disease.
Measured: 1 month after enrollment of the last case
Acute graft-versus-host disease
To compare the incidence and extent of aGVHD between the two groups.
Measured: 100 days after enrollment of the last case
COVID19 related mortality
The percentage of HM patients with COVID-19 who died.
Measured: 100 days after enrollment of the last case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start26 Dec 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Apr 2023 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Suning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Suning, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675826
- Sponsor's protocol ID
- COVID19-HSCT-1
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 12 Jan 2023
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Donor COVID-19 Infection Status on the Recipient in Allogeneic Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT05675826
- Acronym / sponsor ID
- COVID19-HSCT-1
- Conditions
- COVID-19, Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chen SuningUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 9 Jan 2023 (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.
This study was conducted to observe whether COVID-19 can be transmitted through stem cell transplantation and whether COVID-19-positive donors have an effect on early hematopoietic reconstitution and immune reconstitution in the recipients.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced COVID-19 infections are showing an explosive increase in China starting in late 2022. SARS-CoV-2 infections are characterized by an initial viral replication followed by an inflammatory phase with lymphocyte depletion in severe patients.
Past studies have shown that SARS-CoV -2 is detectable in the blood of 8%-15% of patients and that viremia occurs in the first 2-3 days after the onset of symptoms. EBMT, WMDA and other organizations have suggested that COVID-19 positive donors must be excluded or delayed from donation for safety reasons.
However, there have not been any reports of transmission from donor to recipient in blood product transfusion or cell therapy. In the only reported cases of allogeneic HSCT from SARS-CoV-2 positive donors, there was also no evidence of recipient infection from the graft.
In the current situation where the vast majority of people are infected with COVID-19 in the short term, many patients, such as those with leukemia, are in urgent need of transplantation due to the aggressive， hard-to-control，underlying disease. The investigators established this observational clinical trial to investigate whether COVID-19 is transmitted through stem cells and whether COVID-19 positive donors have an impact on early hematopoietic reconstitution and immune reconstitution in recipients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor infected with covid19 | – | –This includes donors who have been infected or are infected with COVID19 at the time of hematopoietic stem cell collection. |
| Donor not infected with covid | – | –Including donors not yet infected with COVID19 at the time of hematopoietic stem cell collection. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population wil be patients who underwent allogeneic HSCT during the COVID19 epidemic.
Key inclusion criteria (3 listed)
- Age between 16 and 65 years old.
- History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma).
- Allogeneic hematopoietic stem cell transplantation perform during the COVID19 pandemic.
Key exclusion criteria (1 listed)
- Hematological diseases, other than hematological malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hematopoietic reconstitution
Time frame: 1 month after enrollment of the last case
To compare the differences in the time of hematopoietic reconstitution between the two groups after transplantation.
3 secondary outcomes
Infection of COVID19
Time frame: 1 month after enrollment of the last case
Acute graft-versus-host disease
Time frame: 100 days after enrollment of the last case
COVID19 related mortality
Time frame: 100 days after enrollment of the last case
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
1 site 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 and Hematopoietic Stem Cell Transplantation, run by Chen Suning at 1 site in China.
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 3 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Suning Chen, PHD (+86-13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematopoietic reconstitution (time frame: 1 month after enrollment of the last case). 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 12 Jan 2023.