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

NCT04402827 | Completed DMC

• 1 other identifier: EC 162/20
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Health Care Worker Patient Transmission; Receptor Site Alteration; Susceptibility, Disease; Immune Response

Keywords

coronavirus, susceptibility, transmission, HCW

Outcome Measures

Primary Outcomes (3)

• Susceptibility to SARS CoV-2 infection according to ACE2 receptor

  ACE2 analysis

  1 month

• Cellular immune response to SARS CoV-2 infection

  Activation of CD4-CD8 by viral peptides

  1 month

• Susceptibility to infections according to KIR phenoytpes

  Analysis of KIR in NK cells

  2 months

Secondary Outcomes (2)

• Characteristics of exposure in time and intensity of HCW with SARS CoV-2 infection

  1 month

• Cellular immune response in HCW with positive IgG against SARS CoV-2

  1 month

Study Arms (2)

Cases

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.

Diagnostic Test: Susceptibility to infection

Controls

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)

Diagnostic Test: Susceptibility to infection

Interventions

Susceptibility to infection DIAGNOSTIC_TEST

ACE2 and CD26 receptor study: After genomic DNA extraction and quantification using a NanoDrop-1000, 14 ACE2 SNPs (rs1978124, rs2048683, rs2074192, rs2106809, rs2285666, rs233575, rs4240157, rs4646142, rs4646155, rs4646156, rs4646188, rs4830542, rs6632677, and rs879922) will be studied. In addition, one CD26 (DPP4) SNP (rs7608798) will be analysed (qualitative measure). SARS-CoV-2 CD4/CD8 T cell response: SARS-CoV-2 peptides (Prot-S, Pros-N and Port-M) will be used to activate CD4 and CD8 T cells. Cytokines released, such as IFNg, TNFa, IL4, IL17A, and IL2, from each cell subset will be measured by flow cytometry (quantitative measure). KIR characterization: Characterization of the presence of 14 genes plus 2 pseudogenes of KIR gene family (qualitative genotyping) by PCR, mRNA expression profiling (quantitative measures) by RT-PCR, and phenotyping of human NK cells analyzing different KIR receptors (quantitative measure) by flow cytometry, will be analyzed.

Also known as: KIR measurements

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Cases: HCW highly exposed to COVID-19 diagnosed patients (see definition) who remained free of symptoms of disease and had a negative serology against SARS-CoV-2 (both IgG and IgM) * Controls: HCW highly exposed to COVID-19 diagnosed patients who had suffered the infection and/or had presence of antibodies in the serological test, paired by sex and age (5 year interval)

You may qualify if:

• HCW older than 18 years
• Highly exposed to COVID-19 according to the definition

You may not qualify if:

• Presence of any disease / treatment which could alter the susceptibility (corticoid therapy, chemotherapy, monoclonal antibodies)
• Pregnancy
• High exposure definition: direct and continued care of COVID-19 diagnosed patients for 2 weeks or more, without aerosol- generating procedures, with inappropriate personal protective equipment (PPE), or unprotected exposure to patients with COVID-19 during aerosol-generating procedures.
• The definition of appropriate PPE was based on previous recommendations. The absence of any part of the PPE constituted an unprotected exposure. We defined the following as aerosol-generating procedures: airway suction, application of a high-flow O2 instrument, bronchoscopy, endotracheal intubation, tracheostomy, nebulizer treatment, sputum induction, positive pressure ventilation, manual ventilation and cardiopulmonary resuscitation.

Sponsors & Collaborators

• Asociacion para el Estudio de las Enfermedades Infecciosas: lead

Study Sites (1)

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

• Vizcarra P, Haemmerle J, Velasco H, Velasco T, Fernandez-Escribano M, Vallejo A, Casado JL. BNT162b2 mRNA COVID-19 vaccine Reactogenicity: The key role of immunity. Vaccine. 2021 Dec 17;39(51):7367-7374. doi: 10.1016/j.vaccine.2021.10.074. Epub 2021 Nov 11.

  PMID: 34802792 DERIVED

MeSH Terms

Conditions

Disease Susceptibility; Coronavirus Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Jose L Casado, MD, PhD

  Ramon y Cajal Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 27, 2020
• Study Start: August 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

ES (1)