Clinical trial NCT04590352: Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients
Official title: Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Keywords: SARS-CoV-2
household contacts
mucosal immunitiy
antibodies
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: laboratory confirmed Sars-Cov-2 cases and their household contacts.

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

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Mucosal antibodies
timeFrame: Day 0
measure: Mucosal antibodies
timeFrame: Day 3 (index cases)
measure: Mucosal antibodies
timeFrame: Day 6 (index cases)
measure: Mucosal antibodies
timeFrame: Day 7 (household contacts)
measure: Mucosal antibodies
timeFrame: Day 14 (household contacts)
measure: Mucosal antibodies in all participants
timeFrame: Day 28
Secondary outcomes:
measure: SARS-CoV-2 infection
timeFrame: day 0
measure: Serum antibodies
timeFrame: day 28
measure: Functional antibody assays
timeFrame: Day 0
measure: Functional antibody assays
timeFrame: Day 3 (index cases)
measure: Functional antibody assays
timeFrame: Day 6 (index cases)
measure: Functional antibody assays
timeFrame: Day 7 (household contacts)
measure: Functional antibody assays
timeFrame: Day 14 (household contacts)
measure: Functional antibody assays
timeFrame: Day 28
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Dimitri Diavatopoulos, Dr
role: PRINCIPAL_INVESTIGATOR
References: