French COVID Cohort (FrenchCOVID)

July 29, 2024 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Clinical Characterisation Protocol for Severe Emerging Infections

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking.

In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility.

The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

4415

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France
        • CHG Agen
      • Aix-en-Provence, France
        • Centre Hospitalier du Pays d'Aix
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • CHU Angers
      • Annecy, France
        • CH Annecy Genevois
      • Antony, France
        • Hôpital Privé d'Antony
      • Ars-Laquenexy, France
        • Hôpital de Mercy. CHR METZ-THIONVILLE
      • Avignon, France
        • Centre Hospitalier Henri Duffaut
      • Besançon, France
        • CHU Jean Minjoz
      • Bobigny, France
        • Hopital Avicenne AP-HP
      • Bordeaux, France
        • CHU Pellegrin
      • Boulogne-Billancourt, France
        • CHU Ambroise Pare
      • Bourg-en-Bresse, France
        • CH Fleyriat
      • Bourgoin-Jallieu, France
        • Centre Hospitalier Pierre Oudot
      • Brest, France
        • CHU Brest
      • Brest, France
        • CHRU Hôpital Cavale Blanche
      • Bron, France
        • Hospices Civils de Lyon
      • Béziers, France
        • Centre Hospitalier de Beziers
      • Cahors, France
        • CH Cahors
      • Calais, France
        • Centre Hospitalier J.E Techer
      • Cayenne, France, 97306
        • Centre Hospitalier Andrée Rosemon
      • Chambéry, France
        • Chms Chambery Nh
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Clermont-Ferrand, France
        • Chu Gabriel Montpied
      • Colmar, France
        • CH Colmar - Hopital Pasteur
      • Colombes, France
        • Hôpital Louis Mourier
      • Contamine-sur-Arve, France
        • Centre Hospitalier Alpes Leman
      • Créteil, France
        • Hôpital Henri Mondor
      • Créteil, France
        • Centre Hospitalier Intercommunal de Creteil
      • Dax, France
        • Centre Hospitalier Dax
      • Dijon, France
        • CHU Dijon Bourgogne
      • Fort De France, France
        • CHU de Martinique
      • Garches, France
        • Hôpital Raymond Poincaré
      • Grenoble, France
        • CHU Grenoble
      • Jossigny, France
        • Grand Hopital de l'Est Francilien site Marne-la-Vallée
      • La Roche-sur-Yon, France
        • CHD les Oudairies
      • Le Kremlin-Bicêtre, France
        • Hôpital Universitaire Bicêtre
      • Le Mans, France
        • CH du Mans
      • Le Puy-en-Velay, France
        • Centre Hospitalier Emile Roux
      • Lille, France
        • Centre Hospitalier Universitaire de Lille
      • Lille, France
        • CHU de Lille
      • Lille, France
        • CHRU Lille, Hôpital Salengro
      • Lyon, France
        • Hopital de la Croix-Rousse
      • Manosque, France
        • Hôpital Louis Raffalli
      • Marseille, France
        • Hôpital Européen
      • Marseille, France
        • Hopital Conception
      • Marseille, France
        • Assistance publique hopitaux de Marseille, hopital Nord
      • Melun, France
        • Groupe Hospitalier Sud Ile de France
      • Mont de Marsan, France
        • CH de Mont Marsan
      • Montivilliers, France
        • Groupe Hospitalier du Havre
      • Montpellier, France
        • CHU Montpellier
      • Nantes, France
        • CHU Nantes
      • Neuilly-sur-Seine, France
        • Hôpital Américain de Paris
      • Nice, France
        • CHU de Nice
      • Nîmes, France
        • CHU Caremeau
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hôpital Saint Louis
      • Paris, France
        • APHP Bichat
      • Paris, France
        • CH Lariboisière
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Groupe Hospitalier Diaconesses Croix Saint-Simon
      • Paris, France
        • La Pitié Salpêtrière
      • Paris, France
        • APHP Tenon
      • Paris, France
        • Hopital Cochin-CIC1417
      • Pau, France
        • Centre Hospitalier de Pau
      • Perpignan, France
        • CH de Perpignan
      • Pierre-Bénite, France
        • Hopital Lyon Sud-HCL
      • Pointe À Pitre, France, 97159
        • CHU de Pointe à Pitre
      • Poitiers, France
        • CHU de Poitiers
      • Périgueux, France
        • Centre Hospitalier de Périgueux
      • Quimper, France
        • CH Cornouaille
      • Reims, France
        • Chu Reims
      • Rennes, France
        • CHU Rennes Hôpital Sud
      • Rennes, France
        • Hôpital Pontchaillou
      • Rouen, France
        • CHU Rouen Normandie
      • Rouen, France
        • CHU Charles Nicole
      • Saint denis, France, 97405
        • CHU Réunion-Felix Guyon
      • Saint-Mandé, France
        • Hopital d'instruction des armées Begin 69
      • Saint-Martin, France
        • Centre hospitalier Louis Constant Fleming
      • Saint-Pierre, France, 97448
        • Groupe Hospitalier Sud Réunion
      • Saint-Étienne, France
        • CHU de Saint-Etienne
      • Saintes, France
        • CH de Saintonge
      • Soissons, France
        • Centre Hospitalier de Soissons
      • Strasbourg, France
        • N.H.C. - Nouvel Hopital Civil
      • Suresnes, France
        • Hôpital Foch
      • Thionville, France
        • CHR Metz-Thionville -Hopital Bel Air
      • Thonon-les-Bains, France
        • Hôpitaux du Léman
      • Toulouse, France
        • CHU de Toulouse
      • Toulouse, France
        • Centre Hospitalier Universitaire de Rangueil
      • Toulouse, France
        • CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse
      • Toulouse, France
        • CHU Toulouse Larrey
      • Tourcoing, France
        • Hôpital Gustave Dron
      • Tours, France
        • CHRU de TOURS
      • Tours, France
        • Centre Hospitalier Régional Universitaire de Tours
      • Vandœuvre-lès-Nancy, France
        • CHU Nancy
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique
      • Villeneuve Saint Georges, France
        • Centre Hospitalier Intercommunal
      • Épagny, France
        • CH Annecy Genevois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will enrol eligible patients (children and adults) with confirmed infection with SARS-CoV-2. Recruitment of patients with Day 1 (enrolment) data is the priority.

The patient's follow-up will be done strictly within the management adapted to his infection. No visits will be made specifically for research purposes. The organisation of convalescence visits is left to the discretion of each centre according to its post-hospitalisation patient follow-up procedures.

Additional biological samples will be collected when samples are taken in the context of care in order to meet the research objectives, with the exception of certain blood samples for pharmacokinetic analyses.

Description

Inclusion Criteria:

- Any patient admitted to a health care facility, with an infection confirmed by SARS-CoV-2 (virologically confirmed diagnosis by PCR).

Non inclusion criteria:

  • Subject deprived of freedom, subject under a legal protective measure
  • Refusal by participant, parent or appropriate representative.

Exclusion Criteria:

- Confirmed diagnosis of another pathogen than SARS-CoV-2 and no indication or likelihood of co-infection with SARS-CoV-2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical features
Time Frame: 18 months

Describe the clinical features of the illness or syndrome (cardio-respiratory signs or symptoms, and laboratory results) and complications, and determinants of severity.

Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
18 months
Response to treatment
Time Frame: 18 months

Describe the response to treatments (including supportive care and novel therapeutics) by clinical, biological, radiological and virological assessments.

Assessment daily for 15 days, then weekly until max 100 days, then 3 and 6 months.
18 months
Pathogen replication, excretion and evolution, within the host
Time Frame: 18 months

high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood, urine, stool, CSF and other samples.

Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
18 months
Immune host responses to infection and therapy
Time Frame: 18 months

Characterise the innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood.

Assessment on Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 then weekly until max 100 days, then 3 and 6 months.
18 months
Host genetic variants
Time Frame: Day 1
Identify host genetic variants associated with disease progression or severity
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Study Chair: Jade GHOSN, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2020

Primary Completion (Estimated)

August 7, 2025

Study Completion (Estimated)

August 7, 2025

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C20-05
  • 2020-A00256-33 (Registry Identifier: RCB ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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