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Completed

NCT Number: NCT04590352

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

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.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasopharyngeal and throat swab

Procedure

diagnostic specimens via nasopharyngeal swab and throat swab were collected following the current standard operating procedures.

collection of mucosal lining fluid

Procedure

MLF will be collected via nasal absorption at the inclusion visit by study staff and four more time points by the parents or by the children themselves. Nasal absorption is performed by maneuvering a strip of synthetic absorptive matrices (SAM) into the lumen of the nostril, avoiding rubbing against the nasal mucosa. The outside of the nose is then pressed with a finger to cause apposition of the SAM against the mucosa.

blood collection via fingerprick

Procedure

Participants will be asked to wash their hands with soap and warm water. The procedure involves cleaning the ball of the fingertip with an alcohol swab, then using a sterile disposable lancet to pierce the skin (BD Microtainer Lancet or similar). The lancet is placed in a spring-loaded device, which propels the lancet a fixed distance (a few mm) into the skin when the trigger is pressed. Approximately 10-20 drops of blood (0.3 ml) will then be collected with a sterile capillary tube. The participant is given a cotton wool pad to mop up any extra blood, and an elastoplast-type bandage is placed over the finger if necessary. Fingerprick blood samples will only be collected from participants older than 6 months at 28-32 days after the first home visit (d0). Lancet length will be adjusted for age (2.0 mm for participants 8 years and older, 1.5 mm for participants older than 6 months and younger than 8 years).

Primary outcomes

  1. Mucosal antibodies

    Time frame: Day 0

    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  2. Mucosal antibodies

    Time frame: Day 3 (index cases)

    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  3. Mucosal antibodies

    Time frame: Day 6 (index cases)

    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  4. Mucosal antibodies

    Time frame: Day 7 (household contacts)

    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  5. Mucosal antibodies

    Time frame: Day 14 (household contacts)

    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  6. Mucosal antibodies in all participants

    Time frame: Day 28

    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

Secondary outcomes

  1. SARS-CoV-2 infection

    Time frame: day 0

    SARS-CoV-2 PCR on nasopharyngeal swab and throat swab

  2. Serum antibodies

    Time frame: day 28

    Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.

  3. Functional antibody assays

    Time frame: Day 0

    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  4. Functional antibody assays

    Time frame: Day 3 (index cases)

    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  5. Functional antibody assays

    Time frame: Day 6 (index cases)

    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  6. Functional antibody assays

    Time frame: Day 7 (household contacts)

    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  7. Functional antibody assays

    Time frame: Day 14 (household contacts)

    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  8. Functional antibody assays

    Time frame: Day 28

    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts

Acronym: MuCo

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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