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French COVID Cohort (FrenchCOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262921
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.


Condition or disease
Coronavirus Infections

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Characterisation Protocol for Severe Emerging Infections
Actual Study Start Date : February 8, 2020
Estimated Primary Completion Date : August 7, 2020
Estimated Study Completion Date : August 7, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical features [ Time Frame: 6 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.


  2. Response to treatment [ Time Frame: 6 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.


  3. Pathogen replication, excretion and evolution, within the host [ Time Frame: 6 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.


  4. Immune host responses to infection and therapy [ Time Frame: 6 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.


  5. Host genetic variants [ Time Frame: Day 1 ]
    Identify host genetic variants associated with disease progression or severity


Biospecimen Retention:   Samples With DNA
Blood, urine, stool /rectal swab, respiratory samples (nose and throat swab, endotracheal aspirate, nasopharyngeal aspirate), samples from infected sites/sores, CSF


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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 a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262921


Contacts
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Contact: Yazdan YAZDANPANAH +33 1 44 23 60 08 yazdan.yazdanpanah@inserm.fr
Contact: Hélène ESPEROU +33 1 44 23 60 70 helene.esperou@inserm.fr

Locations
Show Show 81 study locations
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Chair: Yazdan YAZDANPANAH Institut National de la Santé Et de la Recherche Médicale, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04262921    
Other Study ID Numbers: C20-05
2020-A00256-33 ( Registry Identifier: RCB ID )
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Coronavirus
2019-nCoV
COVID-19
SARS-CoV-2
Cohort
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases