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

SARS-CoV-2 Infection Clinical Trial

— MIViral  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05794412
• Other study ID #: 2022-01722
• Status: Active, not recruiting
• Start date: January 10, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Influenza Viral Infections
• Mucosal Immunity
• Respiratory Syncytial Virus Infections
• RSV Infection
• SARS-CoV-2 Infection
• Virus Diseases
• Virus Shedding

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	ModernaTX, Inc., University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infectious viral load		up to 14 days post symptom onset