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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590352
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment
SARS-CoV-2 Infection Procedure: nasopharyngeal and throat swab Procedure: collection of mucosal lining fluid Procedure: blood collection via fingerprick

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

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Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts
Actual Study Start Date : March 26, 2020
Actual Primary Completion Date : May 13, 2020
Actual Study Completion Date : May 13, 2020

Group/Cohort Intervention/treatment
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
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).




Primary Outcome Measures :
  1. Mucosal antibodies [ Time Frame: Day 0 ]
    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  2. Mucosal antibodies [ Time Frame: Day 3 (index cases) ]
    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  3. Mucosal antibodies [ Time Frame: Day 6 (index cases) ]
    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  4. Mucosal antibodies [ Time Frame: Day 7 (household contacts) ]
    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  5. Mucosal antibodies [ Time Frame: Day 14 (household contacts) ]
    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid

  6. Mucosal antibodies in all participants [ Time Frame: Day 28 ]
    Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid


Secondary Outcome Measures :
  1. SARS-CoV-2 infection [ Time Frame: day 0 ]
    SARS-CoV-2 PCR on nasopharyngeal swab and throat swab

  2. Serum antibodies [ Time Frame: day 28 ]
    Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.

  3. Functional antibody assays [ Time Frame: Day 0 ]
    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  4. Functional antibody assays [ Time Frame: Day 3 (index cases) ]
    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  5. Functional antibody assays [ Time Frame: Day 6 (index cases) ]
    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  6. Functional antibody assays [ Time Frame: Day 7 (household contacts) ]
    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  7. Functional antibody assays [ Time Frame: Day 14 (household contacts) ]
    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies

  8. Functional antibody assays [ Time Frame: Day 28 ]
    Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies


Biospecimen Retention:   Samples Without DNA
nasopharyngeal and throat swab, mucosal lining fluid, serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
laboratory confirmed Sars-Cov-2 cases and their household contacts.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590352


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Dimitri Diavatopoulos, Dr Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04590352    
Other Study ID Numbers: 2020-6342
NL73418.091.20 ( Registry Identifier: CCMO )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
SARS-CoV-2
household contacts
mucosal immunitiy
antibodies
Additional relevant MeSH terms:
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Infection
Communicable Diseases