Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients

Completed

• Conditions: SARS-CoV-2 Infection
• Interventions: Procedure: nasopharyngeal and throat swab; Procedure: collection of mucosal lining fluid; Procedure: blood collection via fingerprick

• Registration Number: NCT04590352
• Lead Sponsor: Radboud University Medical Center

Brief Summary

In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.

Detailed Description

Objective:

Primary Objective: to analyse the development of mucosal immunity against SARS-CoV-2 in nasal fluid of Covid-19 patients and their household contacts

Secondary Objective(s):

* To descriptively analyse the correlation of mucosal antibodies with viral diagnostics and disease symptoms

* To determine the correlation between mucosal and serum antibody levels

* To study the functionality of serum and mucosal antibodies

Study design: A single-site, observational, prospective cohort study among COVID-19 patients and their household contacts Study population: The study will be conducted among COVID-19 patients with a laboratory-confirmed infection with SARS-CoV-2, as well as household contacts remaining in home quarantine at the same address, among secondary and tertiary hospital careworkers in the provinces of Gelderland and Noord-Brabant in The Netherlands.

Intervention (if applicable): N/A

Main study parameters/endpoints:

Mucosal antibodies: descriptive analysis of SARS-CoV-2 IgG, IgA, IgM and IgD concentrations in nasal fluid at the various collection moments.

Viral diagnostics: presence of SARS-CoV-2 in diagnostic specimens collected at inclusion visit.

Disease symptoms: presence of respiratory complaints in participants. Serum antibodies: descriptive analysis of SARS-CoV-antibody concentrations in serum at day 28 Antibody functionality: descriptive analysis of antibody functionality of serum and nasal fluid samples, including virus neutralization

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-26
• Primary Completion: 2020-05-13
• Study Completion: 2020-05-13
• Status Verified: 2020-07
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Index case:

  • Laboratory-confirmed case of SARS-CoV-2, with a positive indication for home isolation, and;
  • With at least 2 household contacts remaining in home quarantine at the same address

• Household contacts For each index case, the study will seek to recruit as many household contacts as possible in the same house as the index case. All household contacts of the index case remaining in home quarantine in the same house as the index case will be asked to participate.

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Exclusion Criteria

• Covid-19 patients with a negative indication for home isolation, or having less than 2 household contacts remaining in home quarantine at the same address. For fingerprick blood collection, participants who have a medical indication against fingerprick blood collection will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Index case and household contacts	nasopharyngeal and throat swab	* nasophryngeal and throat swab at day 0. * collection of mucosal lining fluid: day 0, 7, 14, 28 for index case and day 0, 3, 6, 28 for household contacts. * fingerprick at day 28 (optional). * daily record of symptoms from day 0-28.
Index case and household contacts	collection of mucosal lining fluid	* nasophryngeal and throat swab at day 0. * collection of mucosal lining fluid: day 0, 7, 14, 28 for index case and day 0, 3, 6, 28 for household contacts. * fingerprick at day 28 (optional). * daily record of symptoms from day 0-28.
Index case and household contacts	blood collection via fingerprick	* nasophryngeal and throat swab at day 0. * collection of mucosal lining fluid: day 0, 7, 14, 28 for index case and day 0, 3, 6, 28 for household contacts. * fingerprick at day 28 (optional). * daily record of symptoms from day 0-28.

Primary Outcome Measures

Name	Time	Method
Mucosal antibodies	Day 14 (household contacts)	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies in all participants	Day 28	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Secondary Outcome Measures

Name	Time	Method
Serum antibodies	day 28	Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.
SARS-CoV-2 infection	day 0	SARS-CoV-2 PCR on nasopharyngeal swab and throat swab
Functional antibody assays	Day 28	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands