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

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05794412
• Collaborator: University of Geneva, Switzerland (Other), ModernaTX, Inc. (Industry)
• Enrollment: 320
• Location: 1
• Anticipated Duration (Months): 6.6
• Patients Per Site Per Month: 48.2

Study Details

Study Description

Brief Summary

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 and influenza virus. We will include app 320 participants which will be followed for 6 months. We will monitor their nasal mucosal antibodies at regular intervals (once per month) and compare that to their infectious viral load if they are infected with SARS-CoV-2 and influenza virus.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection; Influenza Viral Infections; Virus Shedding; Mucosal Immunity	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 320 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study
• Actual Study Start Date: Jan 10, 2023
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2 infectious viral load [up to 14 days post symptom onset]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• In general good health, as determined by study investigators

• Living in the canton of Geneva or working/studying in the canton of Geneva and living in one of the neighbouring communities listed below: Mies, Tannay, Chavannes-des-Bois, Commugny, Coppet, Fournex, Chavannes de Bogis, Bogis-Bossey, Ville la Grand, Ambilly, Annemasse, Gaillard, Etrembieres, Bossey, Collonges sous Saleve, Archamps, Neydens, St. Julien en Genevois, Beaumont.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospital	Geneva		Switzerland	1204

Sponsors and Collaborators

• University Hospital, Geneva
• University of Geneva, Switzerland
• ModernaTX, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Isabella Eckerle, Prof., University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT05794412
• Other Study ID Numbers: 2022-01722
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Virus Diseases

Study Results

No Results Posted as of Apr 3, 2023