Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study (MIViral)

January 19, 2024 updated by: Isabella Eckerle, University Hospital, Geneva

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms:

  • Cough
  • Fever
  • Tired
  • Sore throat
  • Difficulty breathing
  • Respiratory distress
  • Headache
  • Loss (or alteration) of smell
  • Loss (or alteration) of sense of taste
  • Myalgias
  • Chills
  • Subjective fever
  • Pink sputum (or coughing up blood)
  • Thoracic pain
  • Runny nose
  • Abdominal pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Irritated or watery eyes
  • Rashes
  • Other

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1204
        • Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adults

Description

Inclusion Criteria:

  • In general good health, as determined by study investigators
  • All participants must be living in the canton of Geneva or working/studying in the canton of Geneva and living in neighboring communities that are within one hour travelling distance by car.

Exclusion Criteria:

  • Inability to provide written consent.
  • Severely immunocompromised subjects as determined by the study investigator
  • Treated with inhaled drugs by nasal route within the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SARS-CoV-2 infectious viral load
Time Frame: up to 14 days post symptom onset
up to 14 days post symptom onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

ModernaTX, Inc.
University of Geneva, Switzerland

Investigators

  • Principal Investigator: Benjamin Meyer, Dr., University of Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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