French COVID Cohort

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronavirus Infections COVID-19 Coronaviridae Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHG Agen, Agen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.
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.
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.
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.
Host genetic variants

Time frame: Day 1

Identify host genetic variants associated with disease progression or severity

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

Clinical Characterisation Protocol for Severe Emerging Infections

Acronym: FrenchCOVID

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Feb 10, 2020
Registry last updated: Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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