Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study

Covid19 Clinical Trial

Official title:

Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932954
• Other study ID #: TJ-IRB20210603
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The patients who were diagnosed with COVID-19 following the WHO interim guidelines (https://www.who.int/publications-detail/clinical-management-of-severe-acute-respirato ry-infection-when-novelcoronavirus-(ncov)-infection-is-suspected. 2020.)

Exclusion Criteria:

• Male or female patients <18 years of age

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
LI YAN	Henan University of Science and Technology, National Institutes of Health (NIH)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	ABO antibody titers	ABO antibody titers refers to both anti-A and anti-B antibodies in severe and non-severe COVID-19 patients	1 year
Secondary	Transfusion incidence	Transfusion incidence refers to the number of COVID-19 hospitalized patients who received transfusion	1 year
Secondary	Patients with coagulopathy	Patients with coagulopathy refers to patients hospitalized with Covid-19 to develop coagulopathy	1 year
Secondary	Leukocyte and neutrophil counts	Leukocyte and neutrophil counts refer to the number of Leukocyte and neutrophil COVID-19 hospitalized patients with graded severity	1 year
Secondary	outcomes of SARS-CoV-2 infection	outcomes of SARS-CoV-2 infection refer to the intubation and death in SARS-CoV-2 infected patients	1 year
Secondary	Polymorphism of ABO blood group	Polymorphism of ABO blood group refers to the variations and alleles of the ABO gene in COVID-19 patients	1 year