NCT04590352

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 187 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
PROCEDURE	nasopharyngeal and throat swab	diagnostic specimens via nasopharyngeal swab and throat swab were collected following the current standard operating procedures.
PROCEDURE	collection of mucosal lining fluid	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.
PROCEDURE	blood collection via fingerprick	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).

Timeline

• Start date: 2020-03-26
• Primary completion: 2020-05-13
• Completion: 2020-05-13
• First posted: 2020-10-19
• Last updated: 2021-01-29

Locations

1 site across 1 country: Netherlands