COVID-19NCT05859958
ABO Blood Group Type Association With COVID-19 Severity
An observational study of COVID-19 and Blood Group Antigen Abnormality, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
The COVID-19 pandemic has caused a significant healthcare burden and remains a heavily researched disease entity. Originating in Wuhan, China in late 2019, SARS-CoV-2 has infected over 600 million individuals worldwide. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Blood Group Antigen Abnormality, Blood Group Incompatibilities
- How many people
- 599 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 10 May 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: To evaluate blood types and their associations with COVID-19 disease severity in patients older than 18 years of age.
Who may be able to join
- At least 18 years of age
- COVID-19 confirmed by laboratory testing (ICD10 U07.1)
- Pneumonia due to COVID-19 (ICD10 J12.82)
- Multisystem inflammatory syndrome from COVID in adults (ICD10 M35.81)
- Adult respiratory distress syndrome (ICD10 J80)
- Abnormal pulmonary function test (ICD10 R94.2)
- Intensive care unit admission for COVID-19
Who cannot join
- COVID-19 Diagnosis under 18 years of age
- COVID in pregnancy (O98.52, O98.511, O98.512, O98.513, O98.519, O98.53)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
Official title: ABO Blood Group Type Association With COVID-19 Severity - A Single Center Study
The COVID-19 pandemic has caused a significant healthcare burden and remains a heavily researched disease entity. Originating in Wuhan, China in late 2019, SARS-CoV-2 has infected over 600 million individuals worldwide. ABO blood groups have been known to increase the human body's susceptibility to different pathogens, such as hepatitis B virus, MERS-COV, SARS-COV, norovirus, and malaria, to name a few. As such, the association of ABO blood groups and COVID-19 infection and disease severity has come into question.
Read the detailed description
The COVID-19 pandemic has caused a significant healthcare burden and remains a heavily researched disease entity. Originating in Wuhan, China in late 2019, SARS-CoV-2 has infected over 600 million individuals worldwide. ABO blood groups have been known to increase the human body's susceptibility to different pathogens, such as hepatitis B virus, MERS-COV, SARS-COV, norovirus, and malaria, to name a few. As such, the association of ABO blood groups and COVID-19 infection and disease severity has come into question.
Early reports have indicated a significant relationship of ABO blood group types to the risk of infection with SARS-CoV-2. Specifically, the first systematic review and meta-analysis by Wu et al. in October 2020 cited that blood type A had increased risk for infection with SARS-CoV-2 and blood type O had decreased risk of infection. Another early meta-analysis by Zaidi et al. cited that blood type A had increased odds of infection, type O had decreased odds of infection, type AB had increased risk of disease severity, and type B had decreased risk of demise.
As more multi-national data became available, as a result of global concerted efforts, larger studies produced data to further investigate this connection. Overall, the majority of studies reproduced similar data: type O had decreased risk of infection with SARS-CoV-2, while type A had increased risk of infection. One study in the United Kingdom failed to produce a relationship between blood types and COVID-19. As more data became available, several studies were able to study the association of blood group type with mortality and disease severity; however, the data regarding this is inconsistent. Gutierrez-Valencia et al. did not find an association with blood types and ICU admission or mechanical ventilation; however, they did note an increased risk of mortality in blood type A. Liu et al. and Pereira et al. demonstrated that there is also increased risk of mortality in blood type A. Jerico et al. noted a lower risk for ICU admission in blood type O. Goel et al. noted an increased risk of disease severity in blood type A. As evident, it seems that blood type A has increased risk of mortality and, likely, disease severity.
In this study, we aim to evaluate association of blood types with mortality and disease severity at a county hospital in Southern California. We will review charts for patients infected with SARS-CoV-2 during a two-year time period, evaluating mortality, oxygen requirements, and patient historical factors. Through this study, we aim to gain a better understanding of how blood group types may affect patient outcomes in the setting of COVID-19.
- Conditions
- COVID-19, Blood Group Antigen Abnormality, Blood Group Incompatibilities, Diabetes Mellitus, COVID-19 Pandemic
- Being tested
- No Intervention
- Medical subject headings
- COVID-19, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Difference in outcomes in patients with COVID-19 diagnosis and ABO blood groups
| Study group | Role | What they receive |
|---|---|---|
| ABO + Group | All patient with blood type that does not include Rhesus Factor and COVID-19 Diagnosis Receives: Other: No Intervention | |
| ABO - Group | All patient with blood type that does not include Rhesus Factor and COVID-19 Diagnosis Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The time spent hospitalized in days.
Measured: Length of total hospital stay from admission in the hospital is defined as the time frame between admission and discharge. The time frame of collection until the event occurred was 360 days.
Hospital Mortality
Survival within the first 28 days
Measured: 28 days
Discharge disposition
Location of discharge after hospital course completed
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 Nov 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859958
- Sponsor's protocol ID
- 22-53
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu BB, Gu DZ, Yu JN, Yang J, Shen WQ. Association between ABO blood groups and COVID-19 infection, severity and demise: A systematic review and meta-analysis. Infect Genet Evol. 2020 Oct;84:104485. doi: 10.1016/j.meegid.2020.104485. Epub 2020 Jul 30.
PubMed 32739464Zaidi FZ, Zaidi ARZ, Abdullah SM, Zaidi SZA. COVID-19 and the ABO blood group connection. Transfus Apher Sci. 2020 Oct;59(5):102838. doi: 10.1016/j.transci.2020.102838. Epub 2020 Jun 3. No abstract available.
PubMed 32513613Gutierrez-Valencia M, Leache L, Librero J, Jerico C, Enguita German M, Garcia-Erce JA. ABO blood group and risk of COVID-19 infection and complications: A systematic review and meta-analysis. Transfusion. 2022 Feb;62(2):493-505. doi: 10.1111/trf.16748. Epub 2021 Nov 19. No abstract available.
PubMed 34773411Fan Q, Zhang W, Li B, Li DJ, Zhang J, Zhao F. Association Between ABO Blood Group System and COVID-19 Susceptibility in Wuhan. Front Cell Infect Microbiol. 2020 Jul 21;10:404. doi: 10.3389/fcimb.2020.00404. eCollection 2020.
PubMed 32793517
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABO Blood Group Type Association With COVID-19 Severity - A Single Center Study
- ClinicalTrials.gov ID
- NCT05859958
- Acronym / sponsor ID
- 22-53
- Conditions
- COVID-19, Blood Group Antigen Abnormality, Blood Group Incompatibilities, Diabetes Mellitus, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 16 May 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 COVID-19 pandemic has caused a significant healthcare burden and remains a heavily researched disease entity. Originating in Wuhan, China in late 2019, SARS-CoV-2 has infected over 600 million individuals worldwide. ABO blood groups have been known to increase the human body's susceptibility to different pathogens, such as hepatitis B virus, MERS-COV, SARS-COV, norovirus, and malaria, to name a few. As such, the association of ABO blood groups and COVID-19 infection and disease severity has come into question.
Detailed description
The COVID-19 pandemic has caused a significant healthcare burden and remains a heavily researched disease entity. Originating in Wuhan, China in late 2019, SARS-CoV-2 has infected over 600 million individuals worldwide. ABO blood groups have been known to increase the human body's susceptibility to different pathogens, such as hepatitis B virus, MERS-COV, SARS-COV, norovirus, and malaria, to name a few. As such, the association of ABO blood groups and COVID-19 infection and disease severity has come into question.
Early reports have indicated a significant relationship of ABO blood group types to the risk of infection with SARS-CoV-2. Specifically, the first systematic review and meta-analysis by Wu et al. in October 2020 cited that blood type A had increased risk for infection with SARS-CoV-2 and blood type O had decreased risk of infection. Another early meta-analysis by Zaidi et al. cited that blood type A had increased odds of infection, type O had decreased odds of infection, type AB had increased risk of disease severity, and type B had decreased risk of demise.
As more multi-national data became available, as a result of global concerted efforts, larger studies produced data to further investigate this connection. Overall, the majority of studies reproduced similar data: type O had decreased risk of infection with SARS-CoV-2, while type A had increased risk of infection. One study in the United Kingdom failed to produce a relationship between blood types and COVID-19. As more data became available, several studies were able to study the association of blood group type with mortality and disease severity; however, the data regarding this is inconsistent. Gutierrez-Valencia et al. did not find an association with blood types and ICU admission or mechanical ventilation; however, they did note an increased risk of mortality in blood type A. Liu et al. and Pereira et al. demonstrated that there is also increased risk of mortality in blood type A. Jerico et al. noted a lower risk for ICU admission in blood type O. Goel et al. noted an increased risk of disease severity in blood type A. As evident, it seems that blood type A has increased risk of mortality and, likely, disease severity.
In this study, we aim to evaluate association of blood types with mortality and disease severity at a county hospital in Southern California. We will review charts for patients infected with SARS-CoV-2 during a two-year time period, evaluating mortality, oxygen requirements, and patient historical factors. Through this study, we aim to gain a better understanding of how blood group types may affect patient outcomes in the setting of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABO + Group | – | Other: No InterventionAll patient with blood type that does not include Rhesus Factor and COVID-19 Diagnosis |
| ABO - Group | – | Other: No InterventionAll patient with blood type that does not include Rhesus Factor and COVID-19 Diagnosis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To evaluate blood types and their associations with COVID-19 disease severity in patients older than 18 years of age.
Key inclusion criteria (7 listed)
- At least 18 years of age
- COVID-19 confirmed by laboratory testing (ICD10 U07.1)
- Pneumonia due to COVID-19 (ICD10 J12.82)
- Multisystem inflammatory syndrome from COVID in adults (ICD10 M35.81)
- Adult respiratory distress syndrome (ICD10 J80)
Key exclusion criteria (2 listed)
- COVID-19 Diagnosis under 18 years of age
- COVID in pregnancy (O98.52, O98.511, O98.512, O98.513, O98.519, O98.53)
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 |
|---|---|---|
| No InterventionDifference in outcomes in patients with COVID-19 diagnosis and ABO blood groups | Other | ABO + Group, ABO - Group |
Primary outcome
Length of hospital stay
Time frame: Length of total hospital stay from admission in the hospital is defined as the time frame between admission and discharge. The time frame of collection until the event occurred was 360 days.
The time spent hospitalized in days.
Hospital Mortality
Time frame: 28 days
Survival within the first 28 days
Discharge disposition
Time frame: 360 days
Location of discharge after hospital course completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 32739464Wu BB, Gu DZ, Yu JN, Yang J, Shen WQ. Association between ABO blood groups and COVID-19 infection, severity and demise: A systematic review and meta-analysis. Infect Genet Evol. 2020 Oct;84:104485. doi: 10.1016/j.meegid.2020.104485. Epub 2020 Jul 30.
- Background: PubMed 32513613Zaidi FZ, Zaidi ARZ, Abdullah SM, Zaidi SZA. COVID-19 and the ABO blood group connection. Transfus Apher Sci. 2020 Oct;59(5):102838. doi: 10.1016/j.transci.2020.102838. Epub 2020 Jun 3. No abstract available.
- Background: PubMed 34773411Gutierrez-Valencia M, Leache L, Librero J, Jerico C, Enguita German M, Garcia-Erce JA. ABO blood group and risk of COVID-19 infection and complications: A systematic review and meta-analysis. Transfusion. 2022 Feb;62(2):493-505. doi: 10.1111/trf.16748. Epub 2021 Nov 19. No abstract available.
- Results publication: PubMed 32793517Fan Q, Zhang W, Li B, Li DJ, Zhang J, Zhao F. Association Between ABO Blood Group System and COVID-19 Susceptibility in Wuhan. Front Cell Infect Microbiol. 2020 Jul 21;10:404. doi: 10.3389/fcimb.2020.00404. eCollection 2020.
- Individual participant dataSharing planned: No
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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 COVID-19 and Blood Group Antigen Abnormality, run by Arrowhead Regional Medical Center at 1 site in United States.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 26 May 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of hospital stay (time frame: Length of total hospital stay from admission in the hospital is defined as the time frame between admission and discharge. The time frame of collection until the event occurred was 360 days.). The study lists 3 primary outcomes in all. 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 NCT05859958, which also lists 4 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 26 May 2023.