Informations générales (source: ClinicalTrials.gov)
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
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2021
janvier 2026
12 septembre 2025
Background:The impact of the emergence of SARS-CoV-2 variants on the severity and
clinical outcomes of COVID-19 is controversial. Whether virological characteristics
including the mutational patterns of the different viral proteins (e.g., Spike, NSP
proteins, ORF6) could be associated with a different immune response and subsequent
severity of the disease is unknown. ln the next coming months, new variants carrying the
same or new mutational patterns will continue to emerge. Monitoring their dynamics over
time and their impact on disease severity is required for refining national and
international disease control policies.
Main objective: To unravel the relationships between specific viral mutations/mutational
patterns and the clinical outcomes of COVID-19 in patients hospitalized in intensive care
units (ICUs) for acute respiratory failure following severe SARS-CoV-2 infection.
Design of the study Prospective multicentre observational cohort study
Schedule for the study: Inclusion period: 24 months; Participation period: 28 days ;
Total duration : 24 months + 28 days;
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER SUD FRANCILIEN | FOURATI Slim | 01/11/2025 07:56:47 | Contacter | ||
| CH VICTOR DUPOUY ARGENTEUIL | FOURATI Slim | 01/11/2025 07:56:47 | Contacter | ||
| CH DE MELUN SITE SANTEPOLE | FOURATI Slim | 01/11/2025 07:56:46 | Contacter | ||
| HOPITAL SAINT CAMILLE | FOURATI Slim | 01/11/2025 07:56:47 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 01/11/2025 07:56:51 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Antoine Béclère | |||||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Louis Mourier | |||||
| AP-HP - Hôpital Raymond Poincaré | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
| AP-HP - Hôpital Tenon | |||||
Critères
Tous
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
- 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
- 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)