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

• Conditions: Covid19

• Registration Number: NCT04932954
• Lead Sponsor: LI YAN

Brief Summary

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 Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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-respiratory-infection-when-novelcoronavirus-(ncov)-infection-is-suspected. 2020.)

Exclusion Criteria

• Male or female patients <18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ABO and Rh distribution	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	1 year	ABO antibody titers refers to both anti-A and anti-B antibodies in severe and non-severe COVID-19 patients

Secondary Outcome Measures

Name	Time	Method
Transfusion incidence	1 year	Transfusion incidence refers to the number of COVID-19 hospitalized patients who received transfusion
outcomes of SARS-CoV-2 infection	1 year	outcomes of SARS-CoV-2 infection refer to the intubation and death in SARS-CoV-2 infected patients
Patients with coagulopathy	1 year	Patients with coagulopathy refers to patients hospitalized with Covid-19 to develop coagulopathy
Leukocyte and neutrophil counts	1 year	Leukocyte and neutrophil counts refer to the number of Leukocyte and neutrophil COVID-19 hospitalized patients with graded severity
Polymorphism of ABO blood group	1 year	Polymorphism of ABO blood group refers to the variations and alleles of the ABO gene in COVID-19 patients

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China