NCT05069389

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,071 (estimated)
• Sponsor: Centre Hospitalier Emile Roux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2020-06-02
• Primary completion: 2023-12-31
• Completion: 2025-07-31
• First posted: 2021-10-06
• Last updated: 2024-07-08

Locations

1 site across 1 country: France