French COVID Cohort
FrenchCOVID
Clinical Characterisation Protocol for Severe Emerging Infections
2 other identifiers
observational
4,415
1 country
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2020
CompletedStudy Start
First participant enrolled
February 8, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2025
CompletedJuly 30, 2024
July 1, 2024
5.5 years
February 6, 2020
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Clinical features
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
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
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
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
Identify host genetic variants associated with disease progression or severity
Day 1
Eligibility Criteria
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.
You may qualify if:
- \- Any patient admitted to a health care facility, with an infection confirmed by SARS-CoV-2 (virologically confirmed diagnosis by PCR).
- Subject deprived of freedom, subject under a legal protective measure
- Refusal by participant, parent or appropriate representative.
You may not qualify if:
- \- Confirmed diagnosis of another pathogen than SARS-CoV-2 and no indication or likelihood of co-infection with SARS-CoV-2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
CHG Agen
Agen, France
Centre Hospitalier Du Pays D'aix
Aix-en-Provence, France
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CH Annecy Genevois
Annecy, France
Hopital privé d'Antony
Antony, France
Hôpital de Mercy. CHR METZ-THIONVILLE
Ars-Laquenexy, France
Centre Hospitalier Henri Duffaut
Avignon, France
Chu Jean Minjoz
Besançon, France
Centre hospitalier de Béziers
Béziers, France
Hôpital Avicenne AP-HP
Bobigny, France
CHU Pellegrin
Bordeaux, France
CHU Ambroise Paré
Boulogne-Billancourt, France
Ch Fleyriat
Bourg-en-Bresse, France
Centre Hospitalier Pierre Oudot
Bourgoin, France
Chru Hopital Cavale Blanche
Brest, France
CHU Brest
Brest, France
Hospices civils de Lyon
Bron, France
CH Cahors
Cahors, France
Centre Hospitalier J.E Techer
Calais, France
Centre Hospitalier Andrée Rosemon
Cayenne, 97306, France
Chms Chambery Nh
Chambéry, France
Centre Hospitalier De Cholet
Cholet, France
CHU Gabriel Montpied
Clermont-Ferrand, France
CH Colmar - Hopital Pasteur
Colmar, France
Hôpital Louis Mourier
Colombes, France
Centre hospitalier Alpes Leman
Contamine-sur-Arve, France
Centre hospitalier Intercommunal de Créteil
Créteil, France
Hôpital Henri Mondor
Créteil, France
Centre Hospitalier Dax
Dax, France
CHU Dijon Bourgogne
Dijon, France
CH Annecy Genevois
Épagny, France
CHU de Martinique
Fort de France, France
Hopital Raymond Poincare
Garches, France
CHU Grenoble
Grenoble, France
Grand Hopital de l'Est Francilien site Marne-la-Vallée
Jossigny, France
Chd Les Oudairies
La Roche-sur-Yon, France
Hôpital Universitaire Bicêtre
Le Kremlin-Bicêtre, France
CH du Mans
Le Mans, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Centre Hospitalier Universitaire de Lille
Lille, France
CHRU Lille, Hôpital Salengro
Lille, France
CHU de Lille
Lille, France
Hôpital de la Croix-Rousse
Lyon, France
Hôpital Louis Raffalli
Manosque, France
Assistance publique hopitaux de Marseille, hopital Nord
Marseille, France
Hopital Européen
Marseille, France
Hôpital Conception
Marseille, France
Groupe Hospitalier Sud Ile De France
Melun, France
CH de Mont Marsan
Mont-de-Marsan, France
Groupe hospitalier du Havre
Montivilliers, France
CHU Montpellier
Montpellier, France
CHU Nantes
Nantes, France
Hopital Américain de Paris
Neuilly-sur-Seine, France
CHU de Nice
Nice, France
CHU Caremeau
Nîmes, France
APHP Bichat
Paris, France
APHP Tenon
Paris, France
CH Lariboisière
Paris, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
Hopital Cochin-CIC1417
Paris, France
Hopital Européen Georges Pompidou
Paris, France
Hopital Saint Antoine
Paris, France
Hopital Saint Louis
Paris, France
La pitié salpetrière
Paris, France
Centre Hospitalier de Pau
Pau, France
CH de Perpignan
Perpignan, France
Centre Hospitalier de Périgueux
Périgueux, France
Hopital Lyon Sud-HCL
Pierre-Bénite, France
CHU de Pointe à Pitre
Pointe à Pitre, 97159, France
CHU de Poitiers
Poitiers, France
Ch Cornouaille
Quimper, France
Chu Reims
Reims, France
CHU Rennes Hopital Sud
Rennes, France
Hôpital Pontchaillou
Rennes, France
CHU Charles Nicole
Rouen, France
CHU Rouen Normandie
Rouen, France
CHU Réunion-Felix Guyon
Saint-Denis, 97405, France
CHU de Saint-Etienne
Saint-Etienne, France
Hopital d'instruction des armées Begin 69
Saint-Mandé, France
Centre hospitalier Louis Constant Fleming
Saint-Martin, France
Groupe Hospitalier Sud Réunion
Saint-Pierre, 97448, France
CH de Saintonge
Saintes, France
Centre Hospitalier de Soissons
Soissons, France
N.H.C. - Nouvel Hopital Civil
Strasbourg, France
Hopital Foch
Suresnes, France
CHR Metz-Thionville -Hopital Bel Air
Thionville, France
Hopitaux du Leman
Thonon-les-Bains, France
Centre Hospitalier Universitaire de Rangueil
Toulouse, France
CHU de Toulouse
Toulouse, France
CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse
Toulouse, France
CHU Toulouse Larrey
Toulouse, France
Hôpital Gustave Dron
Tourcoing, France
Centre Hospitalier Régional Universitaire de Tours
Tours, France
CHRU de Tours
Tours, France
CHU Nancy
Vandœuvre-lès-Nancy, France
Centre Hospitalier Bretagne Atlantique
Vannes, France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, France
Related Publications (10)
Reyes LF, Garcia-Gallo E, Murthy S, Fuentes YV, Serrano CC, Ibanez-Prada ED, Lee J, Rojek A, Citarella BW, Goncalves BP, Dunning J, Ratsep I, Vinan-Garces AE, Kartsonaki C, Rello J, Martin-Loeches I, Shankar-Hari M, Olliaro PL, Merson L; ISARIC Characterisation Group. Major adverse cardiovascular events (MACE) in patients with severe COVID-19 registered in the ISARIC WHO clinical characterization protocol: A prospective, multinational, observational study. J Crit Care. 2023 Oct;77:154318. doi: 10.1016/j.jcrc.2023.154318. Epub 2023 May 9.
PMID: 37167775DERIVEDMatuozzo D, Talouarn E, Marchal A, Zhang P, Manry J, Seeleuthner Y, Zhang Y, Bolze A, Chaldebas M, Milisavljevic B, Gervais A, Bastard P, Asano T, Bizien L, Barzaghi F, Abolhassani H, Abou Tayoun A, Aiuti A, Alavi Darazam I, Allende LM, Alonso-Arias R, Arias AA, Aytekin G, Bergman P, Bondesan S, Bryceson YT, Bustos IG, Cabrera-Marante O, Carcel S, Carrera P, Casari G, Chaibi K, Colobran R, Condino-Neto A, Covill LE, Delmonte OM, El Zein L, Flores C, Gregersen PK, Gut M, Haerynck F, Halwani R, Hancerli S, Hammarstrom L, Hatipoglu N, Karbuz A, Keles S, Kyheng C, Leon-Lopez R, Franco JL, Mansouri D, Martinez-Picado J, Metin Akcan O, Migeotte I, Morange PE, Morelle G, Martin-Nalda A, Novelli G, Novelli A, Ozcelik T, Palabiyik F, Pan-Hammarstrom Q, de Diego RP, Planas-Serra L, Pleguezuelo DE, Prando C, Pujol A, Reyes LF, Riviere JG, Rodriguez-Gallego C, Rojas J, Rovere-Querini P, Schluter A, Shahrooei M, Sobh A, Soler-Palacin P, Tandjaoui-Lambiotte Y, Tipu I, Tresoldi C, Troya J, van de Beek D, Zatz M, Zawadzki P, Al-Muhsen SZ, Alosaimi MF, Alsohime FM, Baris-Feldman H, Butte MJ, Constantinescu SN, Cooper MA, Dalgard CL, Fellay J, Heath JR, Lau YL, Lifton RP, Maniatis T, Mogensen TH, von Bernuth H, Lermine A, Vidaud M, Boland A, Deleuze JF, Nussbaum R, Kahn-Kirby A, Mentre F, Tubiana S, Gorochov G, Tubach F, Hausfater P; COVID Human Genetic Effort; COVIDeF Study Group; French COVID Cohort Study Group; CoV-Contact Cohort; COVID-STORM Clinicians; COVID Clinicians; Orchestra Working Group; Amsterdam UMC Covid-19 Biobank; NIAID-USUHS COVID Study Group; Meyts I, Zhang SY, Puel A, Notarangelo LD, Boisson-Dupuis S, Su HC, Boisson B, Jouanguy E, Casanova JL, Zhang Q, Abel L, Cobat A. Rare predicted loss-of-function variants of type I IFN immunity genes are associated with life-threatening COVID-19. Genome Med. 2023 Apr 5;15(1):22. doi: 10.1186/s13073-023-01173-8.
PMID: 37020259DERIVEDHocini H, Wiedemann A, Blengio F, Lefebvre C, Cervantes-Gonzalez M, Foucat E, Tisserand P, Surenaud M, Coleon S, Prague M, Guillaumat L, Krief C, Fenwick C, Laouenan C, Bouadma L, Ghosn J, Pantaleo G, Thiebaut R; French COVID cohort study group; Levy Y. Neutrophil Activation and Immune Thrombosis Profiles Persist in Convalescent COVID-19. J Clin Immunol. 2023 Jul;43(5):882-893. doi: 10.1007/s10875-023-01459-x. Epub 2023 Mar 21.
PMID: 36943669DERIVEDLegrand M, Fong N, Laouenan C, Ghosn J, Thill B, Faure K, Garot D, Goujard C, Curlier E, Resche-Rigon M, Rossignol P, Pirracchio R. Risk factors of long term symptoms and outcomes among patients discharged after covid-19: prospective, multicentre observational study. BMJ Med. 2022 Jun 17;1(1):e000093. doi: 10.1136/bmjmed-2021-000093. eCollection 2022.
PMID: 36936553DERIVEDBaruch J, Rojek A, Kartsonaki C, Vijayaraghavan BKT, Goncalves BP, Pritchard MG, Merson L, Dunning J, Hall M, Sigfrid L, Citarella BW, Murthy S, Yeabah TO, Olliaro P; ISARIC Clinical Characterisation Group. Symptom-based case definitions for COVID-19: Time and geographical variations for detection at hospital admission among 260,000 patients. Influenza Other Respir Viruses. 2022 Nov;16(6):1040-1050. doi: 10.1111/irv.13039. Epub 2022 Sep 5.
PMID: 36825252DERIVEDMarwali EM, Kekalih A, Yuliarto S, Wati DK, Rayhan M, Valerie IC, Cho HJ, Jassat W, Blumberg L, Masha M, Semple C, Swann OV, Kohns Vasconcelos M, Popielska J, Murthy S, Fowler RA, Guerguerian AM, Streinu-Cercel A, Pathmanathan MD, Rojek A, Kartsonaki C, Goncalves BP, Citarella BW, Merson L, Olliaro PL, Dalton HJ; International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Clinical Characterization Group Investigators. Paediatric COVID-19 mortality: a database analysis of the impact of health resource disparity. BMJ Paediatr Open. 2022 Oct;6(1):e001657. doi: 10.1136/bmjpo-2022-001657.
PMID: 36645791DERIVEDGarcia 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.
PMID: 35891471DERIVEDGault 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.
PMID: 33876439DERIVEDBuetti 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.
PMID: 33066801DERIVEDBouadma 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.
PMID: 32829467DERIVED
Biospecimen
Blood, urine, stool /rectal swab, respiratory samples (nose and throat swab, endotracheal aspirate, nasopharyngeal aspirate), samples from infected sites/sores, CSF
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jade GHOSN
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 10, 2020
Study Start
February 8, 2020
Primary Completion
August 7, 2025
Study Completion
August 7, 2025
Last Updated
July 30, 2024
Record last verified: 2024-07