Covid19NCT04932954
Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study
An observational study of Covid19, run by LI YAN at 1 site in China.
Trial summary
This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were diagnosed with COVID-19 following the WHO interim guidelines and admitted for treatment in Tongji hospital. The admission dates were January 01 2020 to April 01, 2021. Male or female patients <18 years of age were excluded.
Who may be able to join
- The patients who were diagnosed with COVID-19 following the WHO interim guidelines (https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novelcoronavirus-(ncov)-infection-is-suspected. 2020.)
Who cannot join
- Male or female patients <18 years of age
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Li Yan, PhD, 13607124420, yanli008@163.com
Renjie Li, PhD, 18627703102, lirenjiejiayou@126.com
About this study
This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically.
Read the detailed description
This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically. In this study, we will seek to understand the association between SARS-CoV-2 infection and blood groups and explore the Anti-A and Anti-B effects in COVID-19 patients with graded severity. We will analyze the transfusion requirement and the clinical recurrences of COVID-19 patients. The discrepancy of blood group phenotypes in COVID-19 patients with graded severity will be also analyzed on the molecular level. This retrospective cohort study was conducted using electronic health recording data in Tongji Hospital. The clinical characteristics for all eligible patients will be retrieved. The records will be verified to avoid possible bias. Data collection was carried out independently by two investigators and reviewed by two different investigators.
- Conditions
- Covid19
- Keywords
- Immunohematology, Blood group, COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
ABO and Rh distribution
ABO and Rh phenotype distribution refers to the phenotype frequency of the ABO and Rh subtypes in severe and non-severe COVID-19 patients
Measured: 1 year
ABO antibody titers
ABO antibody titers refers to both anti-A and anti-B antibodies in severe and non-severe COVID-19 patients
Measured: 1 year
Secondary outcomes (5)
Transfusion incidence
Transfusion incidence refers to the number of COVID-19 hospitalized patients who received transfusion
Measured: 1 year
Patients with coagulopathy
Patients with coagulopathy refers to patients hospitalized with Covid-19 to develop coagulopathy
Measured: 1 year
Leukocyte and neutrophil counts
Leukocyte and neutrophil counts refer to the number of Leukocyte and neutrophil COVID-19 hospitalized patients with graded severity
Measured: 1 year
outcomes of SARS-CoV-2 infection
outcomes of SARS-CoV-2 infection refer to the intubation and death in SARS-CoV-2 infected patients
Measured: 1 year
Polymorphism of ABO blood group
Polymorphism of ABO blood group refers to the variations and alleles of the ABO gene in COVID-19 patients
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 posted21 Jun 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI YAN
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Henan University of Science and Technology
- Responsible party
- Sponsor-investigator, LI YAN, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932954
- Sponsor's protocol ID
- TJ-IRB20210603
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04932954
- Acronym / sponsor ID
- TJ-IRB20210603
- Conditions
- Covid19
- Keywords
- Immunohematology, Blood group, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- LI YANUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Henan University of Science and Technology
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Jun 2021 (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 is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically.
Detailed description
This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically. In this study, we will seek to understand the association between SARS-CoV-2 infection and blood groups and explore the Anti-A and Anti-B effects in COVID-19 patients with graded severity. We will analyze the transfusion requirement and the clinical recurrences of COVID-19 patients. The discrepancy of blood group phenotypes in COVID-19 patients with graded severity will be also analyzed on the molecular level. This retrospective cohort study was conducted using electronic health recording data in Tongji Hospital. The clinical characteristics for all eligible patients will be retrieved. The records will be verified to avoid possible bias. Data collection was carried out independently by two investigators and reviewed by two different investigators.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were diagnosed with COVID-19 following the WHO interim guidelines and admitted for treatment in Tongji hospital. The admission dates were January 01 2020 to April 01, 2021. Male or female patients <18 years of age were excluded.
Key inclusion criteria (1 listed)
- The patients who were diagnosed with COVID-19 following the WHO interim guidelines (https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novelcoronavirus-(ncov)-infection-is-suspected. 2020.)
Key exclusion criteria (1 listed)
- Male or female patients <18 years of age
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
ABO and Rh distribution
Time frame: 1 year
ABO and Rh phenotype distribution refers to the phenotype frequency of the ABO and Rh subtypes in severe and non-severe COVID-19 patients
ABO antibody titers
Time frame: 1 year
ABO antibody titers refers to both anti-A and anti-B antibodies in severe and non-severe COVID-19 patients
5 secondary outcomes
Transfusion incidence
Time frame: 1 year
Patients with coagulopathy
Time frame: 1 year
Leukocyte and neutrophil counts
Time frame: 1 year
outcomes of SARS-CoV-2 infection
Time frame: 1 year
Polymorphism of ABO blood group
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 21 Jun 2021.
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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 Covid19, run by LI YAN 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: status not confirmed, as of the sponsor's last update on 21 Jun 2021. 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?
ABO and Rh distribution (time frame: 1 year). The study lists 2 primary outcomes in all. 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 21 Jun 2021.