Coronavirus Studied by Metagenomics in ARDS COVID-19 Patients

NCT04516486 | Unknown

• 1 other identifier: APHP200418
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Pandemic SARS-CoV-2 (COVID-19) respiratory infection is responsible for more than 4,000 deaths, mainly (67%) secondary to acute respiratory distress syndromes (ARDS). ARDS is usually associated with a mortality of around 40%, but this rate reaches 61% in patients infected with SARS-CoV-2. Two endotypes have been described in patients with ARDS: one, hyper-inflammatory, associated with very high mortality (51%); the second, slightly inflammatory (immunoparalysis), associated with much lower mortality (19%). In COVID-19 patients, distinct immune response profiles have also been observed. Some patients present deep lymphopenia and/or prolonged viral excretions associated with more frequent occurrence of co-infections (+ 29% of virus, + 23% of bacteria, + 10% of fungi). The latter group may be at higher risk in terms of mortality. The intensity of the inflammatory response and/or microbial coinfections therefore appear as risk factors for severity and mortality in patients infected with SARS-CoV-2 which determine the course of the disease. To adapt early optimal therapeutic management to each forms of the disease, it is essential to be able to characterize these profiles on the microbiological and inflammatory level. With a committed network of 6 intensive-care units across eastern and northern Ile-de-France, 180 patients with ARDS and infected with SARS-CoV-2 are being enrolled. For these patients, a nasopharyngeal swab is collected at inclusion; followed by a new nasopharyngeal swab and a deep respiratory sample once a week, until D28, for an exploration of co-infections and for monitoring the viral load of SARS-CoV-2. The rest of each of these samples are collected for the study. In parallel, the clinical data usually collected in the context of intensive care will be collected on a CRF. They will allow to calculate risk scores such as SOFA.

Conditions

Respiratory Distress Syndrome, Adult; COVID-19

Keywords

Metagenomics; Viral genomic; Transcriptomic; SARS-CoV-2; ARDS

Outcome Measures

Primary Outcomes (1)

• Identify two endotypes (hyper-inflammatory and co-infections) and quantify their prognostic value in terms of short-term mortality (Day 28) in patients treated for ARDS infected with SARS-Cov2.

  Unsupervised Transcriptomic analysis to explore the presence of 2 different groups of patients in the cohort.

  Day 0 to Day 28 (longitudinal study)

Secondary Outcomes (3)

• Nature of viral, bacterial and fungal co-infections in the different clusters identified

  Day 0 to Day 28

• Comparison of SARS CoV-2 viral replication dynamics in the different clusters identified

  Day 0 to Day 28

• 4. Characterization of the viral genetic determinants selected over time in the different clusters identified

  Day 0 to Day 28

Interventions

retrospective metagenomics on clinical samples collected during hospitalization OTHER

Massive sequencing of respiratory samples (restrospective)

Eligibility Criteria

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

Study Population

Patient admitted to intensive care for ARDS (Berlin definition) documented at SARS-CoV-2

You may qualify if:

• Patient admitted to intensive care for ARDS (Berlin definition) documented at SARS-CoV-2
• Major patient (age ≥ 18 years)
• Collection of the non-opposition of the patient or his support person, family member or close friend (newsletter)

You may not qualify if:

• Minor patient
• Refusal to participate in the study
• Patient protected by law
• Prisoner

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Henri Mondor

Créteil, 94000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal Swab, Bronchoalveolar lavage

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Christophe Rodriguez, PharmD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: August 18, 2020
• Study Start: March 9, 2020
• Primary Completion: May 24, 2020
• Study Completion: December 31, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-06

Locations

FR (1)