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

SARS-CoV-2 Infection Clinical Trial

— MuCo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590352
• Other study ID #: 2020-6342
• Secondary ID: NL73418.091.20
• Status: Completed
• Start date: March 26, 2020
• Est. completion date: May 13, 2020

Study information

• Verified date: July 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• SARS-CoV-2 Infection

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal antibodies	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid	Day 0
Primary	Mucosal antibodies	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid	Day 3 (index cases)
Primary	Mucosal antibodies	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid	Day 6 (index cases)
Primary	Mucosal antibodies	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid	Day 7 (household contacts)
Primary	Mucosal antibodies	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid	Day 14 (household contacts)
Primary	Mucosal antibodies in all participants	Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid	Day 28
Secondary	SARS-CoV-2 infection	SARS-CoV-2 PCR on nasopharyngeal swab and throat swab	day 0
Secondary	Serum antibodies	Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.	day 28
Secondary	Functional antibody assays	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies	Day 0
Secondary	Functional antibody assays	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies	Day 3 (index cases)
Secondary	Functional antibody assays	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies	Day 6 (index cases)
Secondary	Functional antibody assays	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies	Day 7 (household contacts)
Secondary	Functional antibody assays	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies	Day 14 (household contacts)
Secondary	Functional antibody assays	Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies	Day 28