Different Susceptibility to SARS CoV-2 Infection Among Health Care Workers Highly Exposed to COVID-19.

Completed

• Conditions: Susceptibility, Disease; Immune Response; Health Care Worker Patient Transmission; Receptor Site Alteration
• Interventions: Diagnostic Test: Susceptibility to infection

• Registration Number: NCT04402827
• Lead Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas

Brief Summary

The primary objective of this study is to establish differences in susceptibility to SARS CoV-2 infection among health care workers (HCW) highly exposed to patients with COVID-19 diagnosis. To ascertain this issue, we evaluated:

* Changes in receptor polymorphism (ACE2 and CD26 receptor study.

* SARS-CoV-2 CD4/CD8 T cell response (CTL)

* Different KIR phenotypes

Detailed Description

Only 24% of health care workers (HCW) had developed inmunological response to SARS CoV-2 infection in one centre attending thousands of COVID-19 patients, and with shorteness of personal protective equipments. Our hypothesis is that this relatively low number of infected HCW could be secondary to:

1. Differences in susceptibility to infection mediated by changes in viral receptors. Thus, it is important to characterize and genotyping the main receptor for SARS-CoV-2, ACE2, and other related receptor, such as CD26.

2. Increased cellular immune response, offering cross-immunity against SARS CoV-2 infection by previous exposure to other coronavirus or respiratory pathogens. A specific CD4/CD8 T cell response to viral peptides could respond this question

3. Specific KIR phenotypes (Killer Immunoglobulin-like Receptors): Natural killer cells (NK) response to alterations of class I HLA molecules presented in infected cells. An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma.

Study Timeline

• Study First Submitted: 2020-05-23
• Study First Submitted QC: 2020-05-23
• Study First Posted: 2020-05-27
• Study Start: 2020-08-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-23
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Susceptibility to infection	HCW highly exposed (defined as more than 15 days of continued personal attention in ICU, anaesthesia, or Infectious Diseases wards) to patients with a diagnosis of COVID-19 (PCR confirmed), who remained asymptomatic and with a negative serology (IgM and IgG negative). Transient entry or stay in the zone (kitchen personnel, rehab members,...) will be not included.
Controls	Susceptibility to infection	HCW highly exposed to PCR-confirmed patients with a diagnosis of COVID-19, as defined above, matched by age and sex, who had suffered confirmed SARS CoV-2 disease (positive PCR or after, positive IgG)

Primary Outcome Measures

Name	Time	Method
Susceptibility to SARS CoV-2 infection according to ACE2 receptor	1 month	ACE2 analysis
Susceptibility to infections according to KIR phenoytpes	2 months	Analysis of KIR in NK cells
Cellular immune response to SARS CoV-2 infection	1 month	Activation of CD4-CD8 by viral peptides

Secondary Outcome Measures

Name	Time	Method
Cellular immune response in HCW with positive IgG against SARS CoV-2	1 month	Activation of CD4-CD8 by viral peptides
Characteristics of exposure in time and intensity of HCW with SARS CoV-2 infection	1 month	Survey

Trial Locations

Locations (1)

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain