COVID-19 InfectionHOPICOVNCT05069389
Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments
An observational study of COVID-19 Infection, run by Centre Hospitalier Emile Roux at 1 site in France.
Trial summary
The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Data collection
- How many people
- 2,071 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient diagnosed for COVID-19 infection and hospitalized in healthcare establishment in 2020
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19
Read the 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
- Being tested
- Data collection
- Keywords
- COVID-19, medical care strategies, hospitalisation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments.
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.
Measured: During the hospitalization
Secondary outcomes (4)
Describe management strategies to take care depending on the patient
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.
Measured: During the hospitalization
Compare patients' clinical course who received different management strategies
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
Measured: During the hospitalization
Evaluate the cost of the care
Costs of specific treatments
Measured: During the hospitalization
Evaluate the effectiveness of the care
Hospitalization time and survival status will be combined to evaluate the effectiveness of the care
Measured: During the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start2 Jun 2020
- Primary completion31 Dec 2023
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,071 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Collaborators
- Médipôle Lyon-Villeurbanne, Centre Hospitalier Memorial France Etats-Unis, Centre Hospitalier de Valence, Centre Hospitalier de Troyes, Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier William Morey - Chalon sur Saône, Centre Hospitalier de Saint-Malo, Centre Hospitalier Intercommunal de Mont de Marsan, Centre Hospitalier Intercommunal de Poissy / Saint-Germain, Centre Hospitalier de Dax, Centre Hospitalier Public du Cotentin, Centre Hospitalier Henri Duffaut - Avignon, Boulogne sur Mer Hospital Center, Centre Hospitalier Louis Pasteur, Chartres, Centre Hospitalier de Montauban, Centre Hospitalier de Saint-Brieuc, Groupe Hospitalier Aube Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069389
- Sponsor's protocol ID
- EDS_2020_HOPICOV
- Acronym
- HOPICOV
- Status last verified
- Jul 2024
- First submitted
- 30 Sep 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments
- ClinicalTrials.gov ID
- NCT05069389
- Acronym / sponsor ID
- HOPICOV / EDS_2020_HOPICOV
- Conditions
- COVID-19 Infection
- Keywords
- COVID-19, medical care strategies, hospitalisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,071 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Collaborators
- Médipôle Lyon-Villeurbanne, Centre Hospitalier Memorial France Etats-Unis, Centre Hospitalier de Valence, Centre Hospitalier de Troyes, Groupe Hospitalier de la Rochelle Ré Aunis, Centre Hospitalier William Morey - Chalon sur Saône, Centre Hospitalier de Saint-Malo, Centre Hospitalier Intercommunal de Mont de Marsan, Centre Hospitalier Intercommunal de Poissy / Saint-Germain, Centre Hospitalier de Dax, Centre Hospitalier Public du Cotentin, Centre Hospitalier Henri Duffaut - Avignon, Boulogne sur Mer Hospital Center, Centre Hospitalier Louis Pasteur, Chartres, Centre Hospitalier de Montauban, Centre Hospitalier de Saint-Brieuc, Groupe Hospitalier Aube Marne
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient diagnosed for COVID-19 infection and hospitalized in healthcare establishment in 2020
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionSome 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 | Other | – |
Primary outcome
Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments.
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.
4 secondary outcomes
Describe management strategies to take care depending on the patient
Time frame: During the hospitalization
Compare patients' clinical course who received different management strategies
Time frame: During the hospitalization
Evaluate the cost of the care
Time frame: During the hospitalization
Evaluate the effectiveness of the care
Time frame: During the hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by Centre Hospitalier Emile Roux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: During the hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.