Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments

NCT ID: NCT05069389

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2071 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-02

Study Completion Date

2025-07-31

Brief Summary

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The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19

Detailed Description

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Coronavirus infection (SARS-Cov2), very contagious, is benign in the most cases but can be complicated by an acute respiratory distress syndrome, for which an invasive mechanical ventilation in resuscitation is necessary with an important mortality rate. This infection is about an important health crisis with a fast saturation of the health system.

In front of the novelty of this virus, any effective treatment has been demonstrated in humans and researches have accelerated as this pandemic continues.

First available results, in chinese population, have not demonstrated superiority of the Lopinavir/Ritonavir association versus standard care (Cao et al. 2020). In a randomized study in 62 chinese patients, Chen et al. seems to find a clinical efficacy of the Hydroxychloroquine compared to placebo. Gautret et al. has also found a decreased viral load in nasopharyngeal swabs in patients affected by COVID-19, treated by Hydroxychloroquine and by the association of Hydroxychloroquine-Azythromycine. However, these preliminary results doesn't allow to conclue on the efficacy against COVID-19.

Currently, any treatment in particular is recommanded for patients affected by COVID-19. Randomized studies on a larger scale and greater rigor at national and european level are in process to determine the efficacy of several treatments.

Pending results of these studies, healthcare establishments had to adapt and strategize to take care their patients. These strategies have rapidely evolved during this pandemy, in terms of the therapeutic clinical studies opening, the acquisition of new knowledges on COVID-19, and treatments.

Screening : All patients with a COVID-19 diagnosis who have been treated in 2020 in participant establishements will be included in the HOPICOV study.

Enrolment : On discharge from hospital, an information notice will be delivered to the patient (or at his close relative / his legal guardian) to allow him to exert his right to oppose his collection data identified as part of the treatment. Otherwise, this information might be send by letter after his discharge.

All participating centers will be encouraged to enter data as things progress to allow interim analysis and scientific communication.

Conditions

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COVID-19 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Data collection

Some data will be collected for all patients included :

* specific treatment administered in COVID unit
* dosages of treatment
* inclusion in clinical trials

Evolution of French recommendations and the publication of scientific articles

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any adult patient admitted to the establishment for treatment for a SARS-Cov2 infection
* Positive RT-PCR or a scanner suggestive of COVID-19 during the stay, or with a positive serology (even if carried out after the patient's discharge)
* Hospitalization \> 24h
* Patients receiving any type of care, whether it is recommended standard care or off-label treatment as part of a therapeutic clinical trial or outside the scope of clinical research

Exclusion Criteria

* Opposition to the use of data following written patient information
* Patient transferred from another hospital to continue COVID care and whose initial care data is not available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Médipôle Lyon-Villeurbanne

OTHER

Sponsor Role collaborator

Centre Hospitalier Memorial France Etats-Unis

OTHER

Sponsor Role collaborator

Centre Hospitalier de Valence

OTHER

Sponsor Role collaborator

Centre Hospitalier de Troyes

OTHER

Sponsor Role collaborator

Groupe Hospitalier La Rochelle Ré Aunis

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier William Morey - Chalon sur Saône

OTHER

Sponsor Role collaborator

Centre Hospitalier de Saint-Malo

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Intercommunal de Mont de Marsan

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Intercommunal de Poissy / Saint-Germain

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier de Dax

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Public du Cotentin

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Henri Duffaut - Avignon

OTHER

Sponsor Role collaborator

Boulogne sur Mer Hospital Center

OTHER

Sponsor Role collaborator

Centre Hospitalier Louis Pasteur, Chartres

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier de Montauban

OTHER

Sponsor Role collaborator

Centre Hospitalier de Saint-Brieuc

OTHER

Sponsor Role collaborator

Groupe Hospitalier Aube Marne

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Emile Roux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Center Emile Roux

Le Puy-en-Velay, , France

Site Status

Countries

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France

Other Identifiers

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EDS_2020_HOPICOV

Identifier Type: -

Identifier Source: org_study_id

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