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

NCT04590352 | Completed

• 2 other identifiers: 2020-6342NL73418.091.20
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2; household contacts; mucosal immunitiy; antibodies

Outcome Measures

Primary Outcomes (6)

• Mucosal antibodies

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

  Day 0

• Mucosal antibodies

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

  Day 3 (index cases)

• Mucosal antibodies

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

  Day 6 (index cases)

• Mucosal antibodies

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

  Day 7 (household contacts)

• Mucosal antibodies

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

  Day 14 (household contacts)

• Mucosal antibodies in all participants

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

  Day 28

Secondary Outcomes (8)

• SARS-CoV-2 infection

  day 0

• Serum antibodies

  day 28

• Functional antibody assays

  Day 0

• Functional antibody assays

  Day 3 (index cases)

• Functional antibody assays

  Day 6 (index cases)

Study Arms (1)

Index case and household contacts

* 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.

Procedure: nasopharyngeal and throat swab; Procedure: collection of mucosal lining fluid; Procedure: blood collection via fingerprick

Interventions

nasopharyngeal and throat swab PROCEDURE

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

Index case and household contacts

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.

Index case and household contacts

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).

Index case and household contacts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

laboratory confirmed Sars-Cov-2 cases and their household contacts.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

• Froberg J, Koomen VJCH, van der Gaast-de Jongh CE, Philipsen R, GeurtsvanKessel CH, de Vries RD, Baas MC, van der Molen RG, de Jonge MI, Hilbrands LB, Huynen MA, Diavatopoulos DA. Primary Exposure to SARS-CoV-2 via Infection or Vaccination Determines Mucosal Antibody-Dependent ACE2 Binding Inhibition. J Infect Dis. 2024 Jan 12;229(1):137-146. doi: 10.1093/infdis/jiad385.

  PMID: 37675756 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasopharyngeal and throat swab, mucosal lining fluid, serum

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dimitri Diavatopoulos, Dr

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: October 19, 2020
• Study Start: March 26, 2020
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: January 29, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)