COVID-19NCT05904067
A Study to Evaluate the Safety and Efficacy of COVID-19 Convalescent Plasma (CCP) Transfusion to Prevent COVID-19 in Adult Recipients Following Hematopoietic Stem Cell Transplantation
A study testing COVID Convalescent Plasma in people with COVID-19 and Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The study is to evaluate the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion to prevent COVID-19 in adult recipients following hematopoietic stem cell transplantation. 72 patients will be randomized in a 1:1 ratio to receive either CCR (36 patients) or not (36 patients). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19, Hematopoietic Stem Cell Transplantation
- What is being tested?
- COVID Convalescent Plasma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 1 Jan 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- receive hematopoietic stem cell transplantation
- Be ≥ 16 years of age on the day of enrollment.
- Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
Who cannot join
- Positive serological response to known HIV or active hepatitis C virus.
- Patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring.
- Unable or unwilling to sign consent form.
- Patients with other special conditions assessed as unqualified by the researchers.
- Patients suffered COVID-19 infection between day 0 and infusion of CCP after transplantation.
- Drop-out and Withdrawal Criteria
Show all 10Show fewer
- Failure of engraftment within 30 days of transplantation;
- Patients who are not compliant with the requirements of the study and fail to follow the study plan.
- Patients receiving prophylaxis for COVID-19 infection by methods other than this protocol during the trial.
- A patient may withdraw from the study if he/she does not wish to continue participating in the study, and the date and reason for withdrawal shall be recorded. The investigator may also decide to discontinue a patient from the clinical study if there is an unacceptable risk.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, None Selected, 300020
Erlie C Plasma, 223909274, doctor_eljiang@163.com
About this study
Official title: Institute of Hematology & Blood Diseases Hospital
The study is to evaluate the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion to prevent COVID-19 in adult recipients following hematopoietic stem cell transplantation.
72 patients will be randomized in a 1:1 ratio to receive either CCR (36 patients) or not (36 patients). Patients in the CCP group will receive 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cell transplantation. Patients in the control group would be routinely given oral ursodeoxycholic acid for +14 days after transplantation.
The primary goal of the study is to evaluate the safety of CCP and the incidence of COVID-19 infection within +28 days after the last infusion of CCP.
- Conditions
- COVID-19, Hematopoietic Stem Cell Transplantation
- Being tested
- COVID Convalescent Plasma
- Keywords
- COVID-19 Convalescent Plasma, 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.
COVID Convalescent PlasmaBiological
Also called CCP, COVID-19 Convalescent Plasma
200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Experimental | Transfusion of COVID-19 convalescent plasma to participants The experimental group (CCP group): 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation. Receives: Biological: COVID Convalescent Plasma |
| Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion | No intervention | Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of new COVID infection
within +28 days after the last infusion of CCP
Measured: 1 year
Secondary outcomes (4)
To evaluate the incidence of severe COVID-19
within +28 days after the last infusion of CCP
Measured: 1 year
To evaluate the survival rate of COVID-19 infection
within 30 days after COVID-19 infection within +28 days after last CCP infusion
Measured: 1 year
To evaluate the overall survival
at 1 year after transplantation.
Measured: 1 year
To evaluate the tolerance of CCP infusion
at 1 year after transplantation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 Jun 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904067
- Sponsor's protocol ID
- CCP-COVID-19-HSCT-2023
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao Y, Li Q, Guo W, Xu M, Fang K, Wang F, Zhang R, Li L, Wei J, Liu Z, Liang C, Zhai W, Ma Q, Chen X, Cao W, Yang D, He Y, Pang A, Feng S, Han M, Sun J, Jiang E. Convalescent plasma therapy for COVID-19 prophylaxis in adults early post-hematopoietic stem cell transplantation: one-year outcomes from a randomized controlled trial. Front Immunol. 2025 Nov 28;16:1626775. doi: 10.3389/fimmu.2025.1626775. eCollection 2025.
PubMed 41394817
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institute of Hematology & Blood Diseases Hospital
- ClinicalTrials.gov ID
- NCT05904067
- Acronym / sponsor ID
- CCP-COVID-19-HSCT-2023
- Conditions
- COVID-19, Hematopoietic Stem Cell Transplantation
- Keywords
- COVID-19 Convalescent Plasma, Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 15 Jun 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.
The study is to evaluate the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion to prevent COVID-19 in adult recipients following hematopoietic stem cell transplantation.
72 patients will be randomized in a 1:1 ratio to receive either CCR (36 patients) or not (36 patients). Patients in the CCP group will receive 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cell transplantation. Patients in the control group would be routinely given oral ursodeoxycholic acid for +14 days after transplantation.
The primary goal of the study is to evaluate the safety of CCP and the incidence of COVID-19 infection within +28 days after the last infusion of CCP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Experimental | Biological: COVID Convalescent PlasmaTransfusion of COVID-19 convalescent plasma to participants The experimental group (CCP group): 200 ml of CCP at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation. |
| Recipient without COVID-19 Convalescent Plasma (CCP) Transfusion | No intervention | –Control group (supportive therapy): patients were routinely given oral ursodeoxycholic acid for +14 days after transplantation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- receive hematopoietic stem cell transplantation
- Be ≥ 16 years of age on the day of enrollment.
- Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
Key exclusion criteria (10 listed)
- Positive serological response to known HIV or active hepatitis C virus.
- Patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring.
- Unable or unwilling to sign consent form.
- Patients with other special conditions assessed as unqualified by the researchers.
- Patients suffered COVID-19 infection between day 0 and infusion of CCP after transplantation.
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 |
|---|---|---|
| COVID Convalescent PlasmaAlso: CCP, COVID-19 Convalescent Plasma200 ml of COVID Convalescent Plasma at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cells transplantation. | Biological | Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion |
Primary outcome
To evaluate the prevalence of new COVID infection
Time frame: 1 year
within +28 days after the last infusion of CCP
4 secondary outcomes
To evaluate the incidence of severe COVID-19
Time frame: 1 year
To evaluate the survival rate of COVID-19 infection
Time frame: 1 year
To evaluate the overall survival
Time frame: 1 year
To evaluate the tolerance of CCP infusion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 41394817Cao Y, Li Q, Guo W, Xu M, Fang K, Wang F, Zhang R, Li L, Wei J, Liu Z, Liang C, Zhai W, Ma Q, Chen X, Cao W, Yang D, He Y, Pang A, Feng S, Han M, Sun J, Jiang E. Convalescent plasma therapy for COVID-19 prophylaxis in adults early post-hematopoietic stem cell transplantation: one-year outcomes from a randomized controlled trial. Front Immunol. 2025 Nov 28;16:1626775. doi: 10.3389/fimmu.2025.1626775. eCollection 2025.
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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.
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID Convalescent Plasma in people with COVID-19 and Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China 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 10 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 15 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the prevalence of new COVID infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05904067, which also lists 1 linked publication.
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 15 Jun 2023.