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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05069389
Acronym
HOPICOV
Enrollment
2071
Registered
2021-10-06
Start date
2020-06-02
Completion date
2025-07-31
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Infection

Keywords

COVID-19, medical care strategies, hospitalisation

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.

Interventions

OTHERData 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

Sponsors

Médipôle Lyon-Villeurbanne
CollaboratorOTHER
Centre Hospitalier Memorial France Etats-Unis
CollaboratorOTHER
Centre Hospitalier de Valence
CollaboratorOTHER
Centre Hospitalier de Troyes
CollaboratorOTHER
Groupe Hospitalier La Rochelle Ré Aunis
CollaboratorUNKNOWN
Centre Hospitalier William Morey - Chalon sur Saône
CollaboratorOTHER
Centre Hospitalier de Saint-Malo
CollaboratorUNKNOWN
Centre Hospitalier Intercommunal de Mont de Marsan
CollaboratorUNKNOWN
Centre Hospitalier Intercommunal de Poissy / Saint-Germain
CollaboratorUNKNOWN
Centre Hospitalier de Dax
CollaboratorUNKNOWN
Centre Hospitalier Public du Cotentin
CollaboratorUNKNOWN
Centre Hospitalier Henri Duffaut - Avignon
CollaboratorOTHER
Boulogne sur Mer Hospital Center
CollaboratorOTHER
Centre Hospitalier Louis Pasteur, Chartres
CollaboratorUNKNOWN
Centre Hospitalier de Montauban
CollaboratorOTHER
Centre Hospitalier de Saint-Brieuc
CollaboratorOTHER
Groupe Hospitalier Aube Marne
CollaboratorUNKNOWN
Centre Hospitalier Emile Roux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments.During the hospitalizationThe use of specific treatments or specific care in COVID unit, inclusion in clinical trials, will be combined to report the evolution of French recommendations and scientific literature around the COVID-19.

Secondary

MeasureTime frameDescription
Describe management strategies to take care depending on the patientDuring the hospitalizationSpecific and non specific administered treatments, inclusion in clinical trials, depending on the patients' age, symptoms at admission, comorbidities (including the presence of renal failure, unbalanced diabetes or heart disorder based on laboratory criteria and ECG) will be combined to describe different management strategies to take care depending on the patient.
Compare patients' clinical course who received different management strategiesDuring the hospitalizationComparison of hospitalization time (days), time between the onset and the end of symptoms (days), passage in intensive care and patients' vital status, according to the treatments received (non-specific / standard versus the different specific treatments administered off-label within the framework of clinical trials or not) will be combined to compare the patients' clinical course who received different management strategies
Evaluate the cost of the careDuring the hospitalizationCosts of specific treatments
Evaluate the effectiveness of the careDuring the hospitalizationHospitalization time and survival status will be combined to evaluate the effectiveness of the care

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026