Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients
NCT ID: NCT04590352
Last Updated: 2021-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
187 participants
OBSERVATIONAL
2020-03-26
2020-05-13
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Dimitri Diavatopoulos, Dr
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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References
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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.
Other Identifiers
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NL73418.091.20
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-6342
Identifier Type: -
Identifier Source: org_study_id