MedTrace Logo

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

NCT05162508 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

OTHER

Nasopharyngeal swab

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Slim FOURATI, MD-PHD · Assistance Publique - Hôpitaux de Paris (AP-HP) Henri Mondor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2026-01-16
Completion
2026-01-16

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162508 on ClinicalTrials.gov