Clinical trial NCT04262921: French COVID Cohort
Official title: Clinical Characterisation Protocol for Severe Emerging Infections
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronavirus Infections
Keywords: Coronavirus
2019-nCoV
COVID-19
SARS-CoV-2
Cohort
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-02-10
Enrollment: 4415
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical features
timeFrame: 18 months
measure: Response to treatment
timeFrame: 18 months
measure: Pathogen replication, excretion and evolution, within the host
timeFrame: 18 months
measure: Immune host responses to infection and therapy
timeFrame: 18 months
measure: Host genetic variants
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Agen
country: France
facility: CHG Agen
city: Aix-en-Provence
country: France
facility: Centre Hospitalier Du Pays D'aix
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: CH Annecy Genevois
city: Antony
country: France
facility: Hopital privé d'Antony
city: Ars-Laquenexy
country: France
facility: Hôpital de Mercy. CHR METZ-THIONVILLE
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
city: Besançon
country: France
facility: Chu Jean Minjoz
city: Bobigny
country: France
facility: Hôpital Avicenne AP-HP
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré
city: Bourg-en-Bresse
country: France
facility: Ch Fleyriat
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot
city: Brest
country: France
facility: Chru Hopital Cavale Blanche
city: Brest
country: France
facility: CHU Brest
city: Bron
country: France
facility: Hospices civils de Lyon
city: Béziers
country: France
facility: Centre hospitalier de Béziers
city: Cahors
country: France
facility: CH Cahors
city: Calais
country: France
facility: Centre Hospitalier J.E Techer
city: Cayenne
country: France
facility: Centre Hospitalier Andrée Rosemon
city: Chambéry
country: France
facility: Chms Chambery Nh
city: Cholet
country: France
facility: Centre Hospitalier De Cholet
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Colmar
country: France
facility: CH Colmar - Hopital Pasteur
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Contamine-sur-Arve
country: France
facility: Centre hospitalier Alpes Leman
city: Créteil
country: France
facility: Centre hospitalier Intercommunal de Créteil
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dax
country: France
facility: Centre Hospitalier Dax
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Fort De France
country: France
facility: CHU de Martinique
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Grenoble
country: France
facility: CHU Grenoble
city: Jossigny
country: France
facility: Grand Hopital de l'Est Francilien site Marne-la-Vallée
city: La Roche-sur-Yon
country: France
facility: Chd Les Oudairies
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Universitaire Bicêtre
city: Le Mans
country: France
facility: CH du Mans
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lille
country: France
facility: CHRU Lille, Hôpital Salengro
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Manosque
country: France
facility: Hôpital Louis Raffalli
city: Marseille
country: France
facility: Assistance publique hopitaux de Marseille, hopital Nord
city: Marseille
country: France
facility: Hopital Européen
city: Marseille
country: France
facility: Hôpital Conception
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile De France
city: Mont de Marsan
country: France
facility: CH de Mont Marsan
city: Montivilliers
country: France
facility: Groupe hospitalier du Havre
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Neuilly-sur-Seine
country: France
facility: Hopital Américain de Paris
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: CHU Caremeau
city: Paris
country: France
facility: APHP Bichat
city: Paris
country: France
facility: APHP Tenon
city: Paris
country: France
facility: CH Lariboisière
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Paris
country: France
facility: Hopital Cochin-CIC1417
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: La pitié salpetrière
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perpignan
country: France
facility: CH de Perpignan
city: Pierre-Bénite
country: France
facility: Hopital Lyon Sud-HCL
city: Pointe À Pitre
country: France
facility: CHU de Pointe à Pitre
city: Poitiers
country: France
facility: CHU de Poitiers
city: Périgueux
country: France
facility: Centre Hospitalier de Périgueux
city: Quimper
country: France
facility: Ch Cornouaille
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: CHU Rennes Hopital Sud
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU Charles Nicole
city: Rouen
country: France
facility: CHU Rouen Normandie
city: Saint denis
country: France
facility: CHU Réunion-Felix Guyon
city: Saint-Mandé
country: France
facility: Hopital d'instruction des armées Begin 69
city: Saint-Martin
country: France
facility: Centre hospitalier Louis Constant Fleming
city: Saint-Pierre
country: France
facility: Groupe Hospitalier Sud Réunion
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Saintes
country: France
facility: CH de Saintonge
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
city: Strasbourg
country: France
facility: N.H.C. - Nouvel Hopital Civil
city: Suresnes
country: France
facility: Hopital Foch
city: Thionville
country: France
facility: CHR Metz-Thionville -Hopital Bel Air
city: Thonon-les-Bains
country: France
facility: Hopitaux du Leman
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Rangueil
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse
city: Toulouse
country: France
facility: CHU Toulouse Larrey
city: Tourcoing
country: France
facility: Hôpital Gustave Dron
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours
city: Tours
country: France
facility: CHRU de Tours
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Villeneuve Saint Georges
country: France
facility: Centre Hospitalier Intercommunal
city: Épagny
country: France
facility: CH Annecy Genevois
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jade GHOSN
role: STUDY_CHAIR
References:
citation: Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.
citation: Gault N, Esposito-Farese M, Revest M, Inamo J, Cabie A, Polard E, Hulot JS, Ghosn J, Chirouze C, Deconinck L, Diehl JL, Poissy J, Epaulard O, Lefevre B, Piroth L, De Montmollin E, Oziol E, Etienne M, Laouenan C, Rossignol P, Costagliola D, Vidal-Petiot E; French-Covid cohort investigators, study group. Chronic use of renin-angiotensin-aldosterone system blockers and mortality in COVID-19: A multicenter prospective cohort and literature review. Fundam Clin Pharmacol. 2021 Dec;35(6):1141-1158. doi: 10.1111/fcp.12683. Epub 2021 May 16.
citation: Buetti N, Wicky PH, Le Hingrat Q, Ruckly S, Mazzuchelli T, Loiodice A, Trimboli P, Forni Ogna V, de Montmollin E, Bernasconi E, Visseaux B, Timsit JF. SARS-CoV-2 detection in the lower respiratory tract of invasively ventilated ARDS patients. Crit Care. 2020 Oct 16;24(1):610. doi: 10.1186/s13054-020-03323-5.
citation: Bouadma L, Wiedemann A, Patrier J, Surenaud M, Wicky PH, Foucat E, Diehl JL, Hejblum BP, Sinnah F, de Montmollin E, Lacabaratz C, Thiebaut R, Timsit JF, Levy Y. Immune Alterations in a Patient with SARS-CoV-2-Related Acute Respiratory Distress Syndrome. J Clin Immunol. 2020 Nov;40(8):1082-1092. doi: 10.1007/s10875-020-00839-x. Epub 2020 Aug 22.