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Coronavirus InfectionsFrenchCOVIDNCT04262921

French COVID Cohort

An observational study of Coronavirus Infections, run by Institut National de la Santé Et de la Recherche Médicale, France at 98 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronavirus Infections
How many people
4,415 participants
Where
98 sitesFrance
Study dates
8 Feb 2020to 7 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

98 sites in 1 country.

98 sites in 1 country

France98 sites

  • CHG Agen

    Agen

  • Centre Hospitalier Du Pays D'aix

    Aix-en-Provence

  • CHU Amiens

    Amiens

  • CHU Angers

    Angers

  • CH Annecy Genevois

    Annecy

  • Hopital privé d'Antony

    Antony

  • Hôpital de Mercy. CHR METZ-THIONVILLE

    Ars-Laquenexy

  • Centre Hospitalier Henri Duffaut

    Avignon

  • Chu Jean Minjoz

    Besançon

  • Centre hospitalier de Béziers

    Béziers

  • Hôpital Avicenne AP-HP

    Bobigny

  • CHU Pellegrin

    Bordeaux

  • CHU Ambroise Paré

    Boulogne-Billancourt

  • Ch Fleyriat

    Bourg-en-Bresse

  • Centre Hospitalier Pierre Oudot

    Bourgoin

  • Chru Hopital Cavale Blanche

    Brest

  • CHU Brest

    Brest

  • Hospices civils de Lyon

    Bron

  • CH Cahors

    Cahors

  • Centre Hospitalier J.E Techer

    Calais

  • Centre Hospitalier Andrée Rosemon

    Cayenne, 97306

  • Chms Chambery Nh

    Chambéry

  • Centre Hospitalier De Cholet

    Cholet

  • CHU Gabriel Montpied

    Clermont-Ferrand

  • CH Colmar - Hopital Pasteur

    Colmar

  • Hôpital Louis Mourier

    Colombes

  • Centre hospitalier Alpes Leman

    Contamine-sur-Arve

  • Centre hospitalier Intercommunal de Créteil

    Créteil

  • Hôpital Henri Mondor

    Créteil

  • Centre Hospitalier Dax

    Dax

  • CHU Dijon Bourgogne

    Dijon

  • CH Annecy Genevois

    Épagny

  • CHU de Martinique

    Fort de France

  • Hopital Raymond Poincare

    Garches

  • CHU Grenoble

    Grenoble

  • Grand Hopital de l'Est Francilien site Marne-la-Vallée

    Jossigny

  • Chd Les Oudairies

    La Roche-sur-Yon

  • Hôpital Universitaire Bicêtre

    Le Kremlin-Bicêtre

  • CH du Mans

    Le Mans

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay

  • Centre Hospitalier Universitaire de Lille

    Lille

  • CHRU Lille, Hôpital Salengro

    Lille

  • CHU de Lille

    Lille

  • Hôpital de la Croix-Rousse

    Lyon

  • Hôpital Louis Raffalli

    Manosque

  • Assistance publique hopitaux de Marseille, hopital Nord

    Marseille

  • Hopital Européen

    Marseille

  • Hôpital Conception

    Marseille

  • Groupe Hospitalier Sud Ile De France

    Melun

  • CH de Mont Marsan

    Mont-de-Marsan

  • Groupe hospitalier du Havre

    Montivilliers

  • CHU Montpellier

    Montpellier

  • CHU Nantes

    Nantes

  • Hopital Américain de Paris

    Neuilly-sur-Seine

  • CHU de Nice

    Nice

  • CHU Caremeau

    Nîmes

  • APHP Bichat

    Paris

  • APHP Tenon

    Paris

  • CH Lariboisière

    Paris

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris

  • Hopital Cochin-CIC1417

    Paris

  • Hopital Européen Georges Pompidou

    Paris

  • Hopital Saint Antoine

    Paris

  • Hopital Saint Louis

    Paris

  • La pitié salpetrière

    Paris

  • Centre Hospitalier de Pau

    Pau

  • Centre Hospitalier de Périgueux

    Périgueux

  • CH de Perpignan

    Perpignan

  • Hopital Lyon Sud-HCL

    Pierre-Bénite

  • CHU de Pointe à Pitre

    Pointe à Pitre, 97159

  • CHU de Poitiers

    Poitiers

  • Ch Cornouaille

    Quimper

  • Chu Reims

    Reims

  • CHU Rennes Hopital Sud

    Rennes

  • Hôpital Pontchaillou

    Rennes

  • CHU Charles Nicole

    Rouen

  • CHU Rouen Normandie

    Rouen

  • CHU Réunion-Felix Guyon

    Saint-Denis, 97405

  • CHU de Saint-Etienne

    Saint-Etienne

  • Hopital d'instruction des armées Begin 69

    Saint-Mandé

  • Centre hospitalier Louis Constant Fleming

    Saint-Martin

  • Groupe Hospitalier Sud Réunion

    Saint-Pierre, 97448

  • CH de Saintonge

    Saintes

  • Centre Hospitalier de Soissons

    Soissons

  • N.H.C. - Nouvel Hopital Civil

    Strasbourg

  • Hopital Foch

    Suresnes

  • CHR Metz-Thionville -Hopital Bel Air

    Thionville

  • Hopitaux du Leman

    Thonon-les-Bains

  • Centre Hospitalier Universitaire de Rangueil

    Toulouse

  • CHU de Toulouse

    Toulouse

  • CHU Toulouse IUCT Institut Universitaire de Cancer de Toulouse

    Toulouse

  • CHU Toulouse Larrey

    Toulouse

  • Hôpital Gustave Dron

    Tourcoing

  • Centre Hospitalier Régional Universitaire de Tours

    Tours

  • CHRU de Tours

    Tours

  • CHU Nancy

    Vandœuvre-lès-Nancy

  • Centre Hospitalier Bretagne Atlantique

    Vannes

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges

Other trials in France

About this study

Official title: 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.

Keywords
Coronavirus, 2019-nCoV, COVID-19, SARS-CoV-2, Cohort
Medical subject headings
Coronavirus Infections, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 18 months

  2. 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.

    Measured: 18 months

  3. 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.

    Measured: 18 months

  4. 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.

    Measured: 18 months

  5. Host genetic variants

    Identify host genetic variants associated with disease progression or severity

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start8 Feb 2020
  3. Primary completion7 Aug 2025 (estimated)
  4. Study completion7 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
4,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262921
Sponsor's protocol ID
C20-05
Other IDs
2020-A00256-33
Acronym
FrenchCOVID
Status last verified
Jul 2024
First submitted
6 Feb 2020
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37167775

  • Matuozzo 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.

    PubMed 37020259

  • Hocini 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.

    PubMed 36943669

  • Legrand 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.

    PubMed 36936553

  • Baruch 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.

    PubMed 36825252

  • Marwali 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.

    PubMed 36645791

  • 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.

    PubMed 35891471

  • 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.

    PubMed 33876439

  • 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.

    PubMed 33066801

  • 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.

    PubMed 32829467

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Infections, run by Institut National de la Santé Et de la Recherche Médicale, France at 98 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical features (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262921, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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