Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NL73418.091.20 | Registry Identifier | CCMO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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):
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Index case and household contacts |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasopharyngeal and throat swab | Procedure | diagnostic specimens via nasopharyngeal swab and throat swab were collected following the current standard operating procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 infection | SARS-CoV-2 PCR on nasopharyngeal swab and throat swab | day 0 |
| Serum antibodies | Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28. |
Not provided
Inclusion Criteria:
Index case:
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:
Not provided
Not provided
Not provided
Not provided
laboratory confirmed Sars-Cov-2 cases and their household contacts.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitri Diavatopoulos, Dr | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37675756 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
nasopharyngeal and throat swab, mucosal lining fluid, serum
| 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). |
|
| day 28 |
| Functional antibody assays | Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies | Day 0 |
| Functional antibody assays | Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies | Day 3 (index cases) |
| Functional antibody assays | Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies | Day 6 (index cases) |
| Functional antibody assays | Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies | Day 7 (household contacts) |
| Functional antibody assays | Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies | Day 14 (household contacts) |
| Functional antibody assays | Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies | Day 28 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |