SARS-CoV-2 InfectionNCT05683353
Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors
An observational study of SARS-CoV-2 Infection and Hematologic Malignancy, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with SARS-CoV-2. Clinical characteristics, treatment options and responses will be collected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Hematologic Malignancy
- What is being tested?
- None intervention
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized patients with SARS-CoV-2 positive hematologic tumors over 18 years old. People with SARS-CoV-2 positive without underlying diseases over 18 years old.
Who may be able to join
- Clinical diagnosis of hematologic tumors Clinical diagnosis of SARS-CoV-2 infection
Who cannot join
- Severe diseases associated with other systems
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors and Discovery of Potential Drug Targets
The goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with SARS-CoV-2. Clinical characteristics, treatment options and responses will be collected. Peripheral blood will be collected from patients with hematologic tumors infected with SARS-CoV-2 and those people without underlying diseases infected with SARS-CoV-2.
Read the detailed description
To establish a retrospective and prospective cohort of patients with hematologic tumors infected with SARS-CoV-2 and people without underlying diseases infected with SARS-CoV-2. Firstly, peripheral blood samples will be collected at infection time points and after SARS-CoV-2 nucleic acid testing turns negative. Subsequently, the transcriptome sequencing and immunological experiments will be performed to analyze the differentially expressed genes, immune function of cells, etc.
Comparative analysis:
- To compare the immune function of patients with hematologic tumors and those without underlying diseases after infection with SARS-CoV-2.
- The transcriptomic and proteomic changes of patients with hematologic tumors are compared with those without underlying diseases after infection with SARS-CoV-2.
- From the perspective of complex (human protein interaction subnetwork), the dynamic change process of SARS-CoV-2-targeted human protein complex (periodic complex) was deeply explored, in order to further analyze its potential dynamic infection mechanism and provide new clues for the discovery of drug targets.
- Conditions
- SARS-CoV-2 Infection, Hematologic Malignancy
- Being tested
- None intervention
- Keywords
- SARS-CoV-2 infection, hematologic malignancy, leukemia, interaction, immune function, network analysis
- Medical subject headings
- COVID-19, Hematologic Neoplasms, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None interventionOther
None intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SARS-CoV-2 positive hematologic tumors | Patients with SARS-CoV-2 positive hematologic tumors over 18 years old excluding patients with severe diseases associated with other systems. Receives: Other: None intervention | |
| People with SARS-CoV-2 positive without underlying diseases | People with SARS-CoV-2 positive without underlying diseases over 18 years old excluding people with severe diseases associated with other systems. Receives: Other: None intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors
To compare the infection mechanism and immune function of patients with hematologic tumors infected with SARS-CoV-2 and people infected with SARS-CoV-2 without underlying diseases.
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 posted13 Jan 2023
- Study start14 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujun DONG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683353
- Sponsor's protocol ID
- PekingUFH_
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naranbhai V, Nathan A, Kaseke C, Berrios C, Khatri A, Choi S, Getz MA, Tano-Menka R, Ofoman O, Gayton A, Senjobe F, Zhao Z, St Denis KJ, Lam EC, Carrington M, Garcia-Beltran WF, Balazs AB, Walker BD, Iafrate AJ, Gaiha GD. T cell reactivity to the SARS-CoV-2 Omicron variant is preserved in most but not all individuals. Cell. 2022 Mar 17;185(6):1041-1051.e6. doi: 10.1016/j.cell.2022.01.029. Epub 2022 Feb 3.
PubMed 35202566Bange EM, Han NA, Wileyto P, Kim JY, Gouma S, Robinson J, Greenplate AR, Hwee MA, Porterfield F, Owoyemi O, Naik K, Zheng C, Galantino M, Weisman AR, Ittner CAG, Kugler EM, Baxter AE, Oniyide O, Agyekum RS, Dunn TG, Jones TK, Giannini HM, Weirick ME, McAllister CM, Babady NE, Kumar A, Widman AJ, DeWolf S, Boutemine SR, Roberts C, Budzik KR, Tollett S, Wright C, Perloff T, Sun L, Mathew D, Giles JR, Oldridge DA, Wu JE, Alanio C, Adamski S, Garfall AL, Vella LA, Kerr SJ, Cohen JV, Oyer RA, Massa R, Maillard IP, Maxwell KN, Reilly JP, Maslak PG, Vonderheide RH, Wolchok JD, Hensley SE, Wherry EJ, Meyer NJ, DeMichele AM, Vardhana SA, Mamtani R, Huang AC. CD8+ T cells contribute to survival in patients with COVID-19 and hematologic cancer. Nat Med. 2021 Jul;27(7):1280-1289. doi: 10.1038/s41591-021-01386-7. Epub 2021 May 20.
PubMed 34017137Ni L, Ye F, Cheng ML, Feng Y, Deng YQ, Zhao H, Wei P, Ge J, Gou M, Li X, Sun L, Cao T, Wang P, Zhou C, Zhang R, Liang P, Guo H, Wang X, Qin CF, Chen F, Dong C. Detection of SARS-CoV-2-Specific Humoral and Cellular Immunity in COVID-19 Convalescent Individuals. Immunity. 2020 Jun 16;52(6):971-977.e3. doi: 10.1016/j.immuni.2020.04.023. Epub 2020 May 3.
PubMed 32413330Auwul MR, Rahman MR, Gov E, Shahjaman M, Moni MA. Bioinformatics and machine learning approach identifies potential drug targets and pathways in COVID-19. Brief Bioinform. 2021 Sep 2;22(5):bbab120. doi: 10.1093/bib/bbab120.
PubMed 33839760Yang S, Fu C, Lian X, Dong X, Zhang Z. Understanding Human-Virus Protein-Protein Interactions Using a Human Protein Complex-Based Analysis Framework. mSystems. 2019 Apr 9;4(2):e00303-18. doi: 10.1128/mSystems.00303-18. eCollection 2019 Mar-Apr.
PubMed 30984872Tang B, Yang X, Tian W, Zhu J, Liu W, Di M, Liu H, Liang Z, Chen Y, Dong Y. Proteomic analysis identifies pathways related to immune dysregulation in patients with hematologic malignancies after COVID-19 infection. Microbiol Spectr. 2026 Aug 4;14(8):e0399625. doi: 10.1128/spectrum.03996-25. Epub 2026 Jul 15.
PubMed 42454903Yang X, Zhu J, Wang Q, Tang B, Shen Y, Wang B, Ji L, Liu H, Wuchty S, Zhang Z, Dong Y, Liang Z. Comparative analysis of dynamic transcriptomes reveals specific COVID-19 features and pathogenesis of immunocompromised populations. mSystems. 2024 Jun 18;9(6):e0138523. doi: 10.1128/msystems.01385-23. Epub 2024 May 16.
PubMed 38752789
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors and Discovery of Potential Drug Targets
- ClinicalTrials.gov ID
- NCT05683353
- Acronym / sponsor ID
- PekingUFH_
- Conditions
- SARS-CoV-2 Infection, Hematologic Malignancy
- Keywords
- SARS-CoV-2 infection, hematologic malignancy, leukemia, interaction, immune function, network analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 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.
The goal of this observational study is to compare the immune function and infection mechanism of patients with hematologic tumors and those people without underlying diseases after infection with SARS-CoV-2. Clinical characteristics, treatment options and responses will be collected. Peripheral blood will be collected from patients with hematologic tumors infected with SARS-CoV-2 and those people without underlying diseases infected with SARS-CoV-2.
Detailed description
To establish a retrospective and prospective cohort of patients with hematologic tumors infected with SARS-CoV-2 and people without underlying diseases infected with SARS-CoV-2. Firstly, peripheral blood samples will be collected at infection time points and after SARS-CoV-2 nucleic acid testing turns negative. Subsequently, the transcriptome sequencing and immunological experiments will be performed to analyze the differentially expressed genes, immune function of cells, etc.
Comparative analysis:
- To compare the immune function of patients with hematologic tumors and those without underlying diseases after infection with SARS-CoV-2.
- The transcriptomic and proteomic changes of patients with hematologic tumors are compared with those without underlying diseases after infection with SARS-CoV-2.
- From the perspective of complex (human protein interaction subnetwork), the dynamic change process of SARS-CoV-2-targeted human protein complex (periodic complex) was deeply explored, in order to further analyze its potential dynamic infection mechanism and provide new clues for the discovery of drug targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SARS-CoV-2 positive hematologic tumors | – | Other: None interventionPatients with SARS-CoV-2 positive hematologic tumors over 18 years old excluding patients with severe diseases associated with other systems. |
| People with SARS-CoV-2 positive without underlying diseases | – | Other: None interventionPeople with SARS-CoV-2 positive without underlying diseases over 18 years old excluding people with severe diseases associated with other systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with SARS-CoV-2 positive hematologic tumors over 18 years old. People with SARS-CoV-2 positive without underlying diseases over 18 years old.
Key inclusion criteria (1 listed)
- Clinical diagnosis of hematologic tumors Clinical diagnosis of SARS-CoV-2 infection
Key exclusion criteria (1 listed)
- Severe diseases associated with other systems
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 |
|---|---|---|
| None interventionNone intervention. | Other | Patients with SARS-CoV-2 positive hematologic tumors, People with SARS-CoV-2 positive without underlying diseases |
Primary outcome
Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors
Time frame: 1 year
To compare the infection mechanism and immune function of patients with hematologic tumors infected with SARS-CoV-2 and people infected with SARS-CoV-2 without underlying diseases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 35202566Naranbhai V, Nathan A, Kaseke C, Berrios C, Khatri A, Choi S, Getz MA, Tano-Menka R, Ofoman O, Gayton A, Senjobe F, Zhao Z, St Denis KJ, Lam EC, Carrington M, Garcia-Beltran WF, Balazs AB, Walker BD, Iafrate AJ, Gaiha GD. T cell reactivity to the SARS-CoV-2 Omicron variant is preserved in most but not all individuals. Cell. 2022 Mar 17;185(6):1041-1051.e6. doi: 10.1016/j.cell.2022.01.029. Epub 2022 Feb 3.
- Background: PubMed 34017137Bange EM, Han NA, Wileyto P, Kim JY, Gouma S, Robinson J, Greenplate AR, Hwee MA, Porterfield F, Owoyemi O, Naik K, Zheng C, Galantino M, Weisman AR, Ittner CAG, Kugler EM, Baxter AE, Oniyide O, Agyekum RS, Dunn TG, Jones TK, Giannini HM, Weirick ME, McAllister CM, Babady NE, Kumar A, Widman AJ, DeWolf S, Boutemine SR, Roberts C, Budzik KR, Tollett S, Wright C, Perloff T, Sun L, Mathew D, Giles JR, Oldridge DA, Wu JE, Alanio C, Adamski S, Garfall AL, Vella LA, Kerr SJ, Cohen JV, Oyer RA, Massa R, Maillard IP, Maxwell KN, Reilly JP, Maslak PG, Vonderheide RH, Wolchok JD, Hensley SE, Wherry EJ, Meyer NJ, DeMichele AM, Vardhana SA, Mamtani R, Huang AC. CD8+ T cells contribute to survival in patients with COVID-19 and hematologic cancer. Nat Med. 2021 Jul;27(7):1280-1289. doi: 10.1038/s41591-021-01386-7. Epub 2021 May 20.
- Background: PubMed 32413330Ni L, Ye F, Cheng ML, Feng Y, Deng YQ, Zhao H, Wei P, Ge J, Gou M, Li X, Sun L, Cao T, Wang P, Zhou C, Zhang R, Liang P, Guo H, Wang X, Qin CF, Chen F, Dong C. Detection of SARS-CoV-2-Specific Humoral and Cellular Immunity in COVID-19 Convalescent Individuals. Immunity. 2020 Jun 16;52(6):971-977.e3. doi: 10.1016/j.immuni.2020.04.023. Epub 2020 May 3.
- Background: PubMed 33839760Auwul MR, Rahman MR, Gov E, Shahjaman M, Moni MA. Bioinformatics and machine learning approach identifies potential drug targets and pathways in COVID-19. Brief Bioinform. 2021 Sep 2;22(5):bbab120. doi: 10.1093/bib/bbab120.
- Background: PubMed 30984872Yang S, Fu C, Lian X, Dong X, Zhang Z. Understanding Human-Virus Protein-Protein Interactions Using a Human Protein Complex-Based Analysis Framework. mSystems. 2019 Apr 9;4(2):e00303-18. doi: 10.1128/mSystems.00303-18. eCollection 2019 Mar-Apr.
- Derived from this study: PubMed 42454903Tang B, Yang X, Tian W, Zhu J, Liu W, Di M, Liu H, Liang Z, Chen Y, Dong Y. Proteomic analysis identifies pathways related to immune dysregulation in patients with hematologic malignancies after COVID-19 infection. Microbiol Spectr. 2026 Aug 4;14(8):e0399625. doi: 10.1128/spectrum.03996-25. Epub 2026 Jul 15.
- Derived from this study: PubMed 38752789Yang X, Zhu J, Wang Q, Tang B, Shen Y, Wang B, Ji L, Liu H, Wuchty S, Zhang Z, Dong Y, Liang Z. Comparative analysis of dynamic transcriptomes reveals specific COVID-19 features and pathogenesis of immunocompromised populations. mSystems. 2024 Jun 18;9(6):e0138523. doi: 10.1128/msystems.01385-23. Epub 2024 May 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV-2 Infection and Hematologic Malignancy, run by Peking University First Hospital 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 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanism and Immune Function Analysis of SARS-CoV-2 Infection in Hematologic Tumors (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 NCT05683353, which also lists 7 linked publications.
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 16 Sep 2026.