Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

COVID-19 Clinical Trial

— RESPIVAC  

Official title:

Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582239
• Other study ID #: ANRS0285s
• Status: Recruiting
• Start date: January 20, 2023
• Est. completion date: January 20, 2026

Study information

• Verified date: May 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: Claire Rekacewicz, MD
• Phone: + 33 1 42 34 83 75
• Email: claire.rekacewicz[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.

Description:

Participation to the study will be systematically proposed to all patients hospitalized fitting inclusion criteria. Patient's screening will be done in emergency department or hospital department with direct admission. Medical investigators explain the objectives of the studies, procedure and propose the patient to participate in the study. Socio-demographic data, clinical and virological data will be collected in an electronic clinical research form.

A follow-up at 1 and 3 months after hospitalization discharge will be scheduled to evaluate health status.

The remainder of respiratory samples that have been performed for care will be used for further testing depending on epidemiological situation and will be stored at -80°C.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: January 20, 2026
• Est. primary completion date: January 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Admitted in a hospital for at least 24 h

• Presents SARI criteria within onset within the last 14 days before sampling and less than 48 h after hospitalisations:

At least one of the following signs (without treatment): fever or feverishness, malaise, headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness) Associated with at least one respiratory symptom or sign (cough, sore throat or shortness of breath; or tachypnoea or signs of low oxygen saturation)

• completed non-opposition form

• Respiratory samples within 14 days after symptoms onset, in the context of care

Exclusion Criteria:

• Contraindication of vaccination

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Influenza
• Respiratory Tract Infections
• Severe Acute Respiratory Infection (SARI)

Locations

Country	Name	City	State
France	CHU	Dijon
France	Groupement hospitalier Edouard Herriot	Lyon
France	Hôpital Gui de Chauliac	Montpellier
France	CHU	Nantes
France	Hôpital Bichat	Paris
France	Hôpital Cochin	Paris
France	CHU	Rennes
France	CHU	Saint-Étienne

Sponsors (5)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	EPICONCEPT, I-REIVAC, Institut de Recherche en Santé Publique, France, P95

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine effectiveness	Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients.	up to 48 hours
Secondary	Covid-19 vaccine effectiveness	Comparison of numbers of hospitalized cases with documented COVID-19 infection in vaccinated and unvaccinated patients according to: Age; comorbidities; Vaccine schedule (numbers of doses and brand); date of vaccination; SARS-CoV-2 Variant	up to 48 hours
Secondary	Influenza vaccine effectiveness	Comparison of numbers of hospitalized cases with documented flu in vaccinated and unvaccinated according to: Age; Comorbidities; Vaccine brand; Date of vaccination; Previous vaccination; Viral strain	up to 48 hours
Secondary	Prevalence of viral and bacterial co-infections	Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.	up to 48 hours
Secondary	Incidence of SARI by site	Incidence rate of SARI by sites	up to 12 months
Secondary	Clinical burden of SARI	European Quality of Life by 5 Dimension (EQ5D) score assessed at 1 month and 3 months after hospitalization discharge. Scale from 0 to 100 with 0 corresponding to the worst quality of life.	up to 3 months