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A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) (COVIDothèque)

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ClinicalTrials.gov Identifier: NCT04347850
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system.

The main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.


Condition or disease Intervention/treatment
SARS-CoV-2 COVID-19 Other: blood sample

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 30, 2022

Group/Cohort Intervention/treatment
Patient with Covid-19 confirmed (middle form)
Covid-19 confirmed: middle form
Other: blood sample
Collection

Patient with Covid-19 confirmed (severe form)
Covid-19 confirmed : severe form
Other: blood sample
Collection

Patient with Covid-19 not confirmed
Covid-19 not confirmed
Other: blood sample
Collection




Primary Outcome Measures :
  1. Number of confirmed COVID-19 [ Time Frame: 1 day ]
    Number of confirmed COVID-19


Secondary Outcome Measures :
  1. Number of severe COVID-19 [ Time Frame: 1 day ]
    Number of severe COVID-19

  2. Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection [ Time Frame: 1 day ]
    CORO-TRI substudy

  3. Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France [ Time Frame: 1 day ]
    COVID-CHD substudy

  4. Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care [ Time Frame: 1 day ]
    Physio-Covid substudy

  5. To assess the accuracy and prognostic performance of clinical and biological parameters measured on admission to the emergency department to stratify patients suspected of COVID-19 [ Time Frame: 1 day ]
    Covida substudy

  6. Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure [ Time Frame: 1 day ]
    Olfa-covid substudy

  7. Assessment of Extra Vascular Lung Water and Pulmonary Permeability by transpulmonary thermodilution in critically ill patients with Coronavirus Disease 2019 pneumonia under invasive mechanical ventilation [ Time Frame: 1 day ]
    PiCCOVID substudy

  8. Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care [ Time Frame: 1 day ]
    TRANSPULMONARY-COVID19 substudy

  9. Immuno-monitoring of COVID-19 positive patients [ Time Frame: 1 day ]
    CytoCOVID substudy

  10. Characterization in clinical proteomics of the SARS-CoV-2 spike protein [ Time Frame: 1 day ]
    ProteoCOVID substudy

  11. Diagnosis of endocrine dysfunctions in Covid-19 [ Time Frame: 1 day ]
    Dyhor-19 substudy

  12. describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term [ Time Frame: 1 day ]
    Lupus substudy

  13. Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature [ Time Frame: 1 day ]
    Vasculopathy substudy

  14. Evaluation of a COVID-19 screening strategy combining chest low dose CT and RT-PCR test for patients admitted for surgical or interventional procedures during the COVID 19 outbreak [ Time Frame: 1 day ]
    COVID-Scan study


Biospecimen Retention:   Samples Without DNA
Plasma, serum, total blood, urine, stool, oral fluid


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.
Criteria

Inclusion criteria:

- Patients care at the Montpellier University Hospital suspected of a COVID-19 infection

Exclusion criteria:

  • Patient opposed to the use of his data for research purposes
  • Patient deprived of liberty by judicial decision
  • Patient not affiliated to a social security scheme

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): NCT04347850


Contacts
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Contact: Edouard TUAILLON, MD; PhD 467 338 469 ext 33 e-tuaillon@chu-montpellier.fr

Locations
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France
Uh Montpellier Recruiting
Montpellier, France, 34280
Contact: Edouard TUAILLON, MD; PhD    467 338 469 ext 33    e-tuaillon@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Edouard TUAILLON, MD; PhD UH MONTPELLIER
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04347850    
Other Study ID Numbers: RECHMPL20_0185
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NC

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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 University Hospital, Montpellier:
presence of COVID-19 symptoms
COVID-19 infection
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases