NCT05859958

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
599

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 15, 2023

Last Update Submit

May 24, 2023

Conditions

COVID-19Blood Group Antigen AbnormalityBlood Group IncompatibilitiesDiabetes MellitusCOVID-19 Pandemic

Outcome Measures

Primary Outcomes (3)

  • Length of hospital stay

    The time spent hospitalized in days.

    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

    28 days

  • Discharge disposition

    Location of discharge after hospital course completed

    360 days

Study Arms (2)

ABO + Group

All patient with blood type that does not include Rhesus Factor and COVID-19 Diagnosis

Other: No Intervention

ABO - Group

All patient with blood type that does not include Rhesus Factor and COVID-19 Diagnosis

Other: No Intervention

Interventions

No InterventionOTHER

Difference in outcomes in patients with COVID-19 diagnosis and ABO blood groups

ABO + GroupABO - Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To evaluate blood types and their associations with COVID-19 disease severity in patients older than 18 years of age.

You may qualify if:

  • 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

You may not qualify if:

  • COVID-19 Diagnosis under 18 years of age
  • COVID in pregnancy (O98.52, O98.511, O98.512, O98.513, O98.519, O98.53)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (4)

  • 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.

    PMID: 32739464BACKGROUND

  • Zaidi 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.

    PMID: 32513613BACKGROUND

  • Gutierrez-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.

    PMID: 34773411BACKGROUND

  • Fan 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.

    PMID: 32793517RESULT

MeSH Terms

Conditions

COVID-19Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 16, 2023

Study Start

November 10, 2022

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)