Examining the impact of COVID-19 variants on severe disease outcomes in ICU patients
Characterization of the Impact of SARS-CoV-2 Variability on the Course of COVID-19 in Patients With Severe Disease Hospitalized in Intensive Care Units: Prospective Observational Multicentric Study
This study is trying to see how different COVID-19 variants affect the health outcomes of patients in the ICU who are suffering from severe illness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, Val De Marne) |
| Trial ID | NCT05162508 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between specific mutations of the SARS-CoV-2 virus and the clinical outcomes of patients hospitalized in intensive care units (ICUs) due to severe COVID-19. By analyzing nasopharyngeal swabs from patients with acute respiratory failure, the study seeks to understand how different viral variants may influence disease severity and immune response. The research is designed as a prospective multicenter cohort study, allowing for the monitoring of viral dynamics and their implications for public health policies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are hospitalized in the ICU with acute respiratory failure due to confirmed SARS-CoV-2 infection.
Not a fit: Patients with SARS-CoV-2 infection who do not experience acute respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how COVID-19 variants affect patient outcomes, potentially guiding treatment and prevention strategies.
How similar studies have performed: While the impact of specific SARS-CoV-2 variants on disease severity is still being explored, preliminary studies have indicated varying outcomes associated with different variants, suggesting that this area of research is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Availability of nasopharyngeal swab from SOC * SARS-CoV-2 infection as assessed by a positive RT-PCR test (CT \< 32), including in SARS CoV-2 vaccinated or previously infected patients * Patient admitted in the ICU for acute respiratory failure (SpO2 ≤ 90% and need for supplemental oxygen or any kind of ventilator support; i.e., OMS 10-category ordinal scale ≥5) * Patient or trusted person or close or relative, And, accepting study participation Exclusion Criteria: * Patient with SARS-CoV-2 infection but no acute respiratory failure * Patient deprived of liberty or under legal protection (guardianship, curators, legal protection, forced hospitalization)
Where this trial is running
Créteil, Val De Marne
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR — Créteil, Val De Marne, France (Recruiting)
Study contacts
- Principal investigator: Slim FOURATI, MD-PHD — Assistance Publique - Hôpitaux de Paris (AP-HP) Henri Mondor
- Study coordinator: Nicolas DE PROST, MD-PHD
- Email: nicolas.de-prost@aphp.fr
- Phone: 0149878506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.