Hospital Center Emile Roux
Le Puy-en-Velay, 43012, France
NCT Number: NCT05069389
The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Le Puy-en-Velay, 43012, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Some data will be collected for all patients included :
Evolution of French recommendations and the publication of scientific articles
Time frame: During the hospitalization
The 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.
Time frame: During the hospitalization
Specific 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.
Time frame: During the hospitalization
Comparison 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
Time frame: During the hospitalization
Costs of specific treatments
Time frame: During the hospitalization
Hospitalization time and survival status will be combined to evaluate the effectiveness of the care
Centre Hospitalier Emile Roux
Other
Acronym: HOPICOV
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.
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