Impact of COVID-19 SARS-CoV-2 Variability in ICU Hospitalized Patients With Severe Disease

NCT05162508 | Unknown

• 1 other identifier: APHP211494
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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;

Conditions

SARS-CoV2 Infection; COVID-19 Acute Respiratory Distress Syndrome; Mutation

Outcome Measures

Primary Outcomes (1)

• Day-28 vital status

  vital status (living / deceased)

  at Day-28 after admission in intensive care units (ICUs) for acute respiratory failure following severe SARS-CoV-2 infection

Interventions

Nasopharyngeal swab OTHER

Nasopharyngeal swab available in Standard Of Care (SOC) will be analysed (Full-length SARS-CoV-2 RNA sequencing and Transcriptomic analyses)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe SARS-CoV-2 infection and acute respiratory failure admitted in one of the participating ICUs during 2 years of inclusion period.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, Val De Marne, 94010, France

RECRUITING

Related Publications (1)

• Audureau E, Bay P, Preau S, Favory R, Guigon A, Heming N, Gault E, Pham T, Chaghouri A, Turpin M, Morand-Joubert L, Jochmans S, Pitsch A, Meireles S, Contou D, Henry A, Roux D, Le Hingrat Q, Kimmoun A, Hartard C, Pene F, L'Honneur AS, Guillon A, Handala L, Tamion F, Moisan A, Daix T, Hantz S, Delamaire F, Thibault V, Darreau C, Thomin J, Pawlotsky JM, Fourati S, de Prost N; SEVARVIR investigators. Clinical Phenotypes of Critically Ill Patients with COVID-19 Infected with Omicron: A Nationwide Prospective Cohort Study. Infect Dis Ther. 2026 Jan 6. doi: 10.1007/s40121-025-01291-3. Online ahead of print.

  PMID: 41493514 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swab

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Slim FOURATI, MD-PHD

  Assistance Publique - Hôpitaux de Paris (AP-HP) Henri Mondor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas DE PROST, MD-PHD

CONTACT

0149878506; nicolas.de-prost@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 17, 2021
• Study Start: December 16, 2021
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)