Clinical trial NCT05069389: Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments
Official title: Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19 Infection
Keywords: COVID-19
medical care strategies
hospitalisation
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
Collaborators: name: Médipôle Lyon-Villeurbanne
name: Centre Hospitalier Memorial France Etats-Unis
name: Centre Hospitalier de Valence
name: Centre Hospitalier de Troyes
name: Groupe Hospitalier La Rochelle Ré Aunis
name: Centre Hospitalier William Morey - Chalon sur Saône
name: Centre Hospitalier de Saint-Malo
name: Centre Hospitalier Intercommunal de Mont de Marsan
name: Centre Hospitalier Intercommunal de Poissy / Saint-Germain
name: Centre Hospitalier de Dax
name: Centre Hospitalier Public du Cotentin
name: Centre Hospitalier Henri Duffaut - Avignon
name: Boulogne sur Mer Hospital Center
name: Centre Hospitalier Louis Pasteur, Chartres
name: Centre Hospitalier de Montauban
name: Centre Hospitalier de Saint-Brieuc
name: Groupe Hospitalier Aube Marne
First posted: 2021-10-06
Enrollment: 2071
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient diagnosed for COVID-19 infection and hospitalized in healthcare establishment in 2020

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments.
timeFrame: During the hospitalization
Secondary outcomes:
measure: Describe management strategies to take care depending on the patient
timeFrame: During the hospitalization
measure: Compare patients' clinical course who received different management strategies
timeFrame: During the hospitalization
measure: Evaluate the cost of the care
timeFrame: During the hospitalization
measure: Evaluate the effectiveness of the care
timeFrame: During the hospitalization
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Hospital Center Emile Roux
Study officials:
References: