Covid-19NCT04362345
Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia
An observational study of Covid-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2020to 9 Jan 2021
- 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 Patients with Covid-19
Who may be able to join
- Major patient (≥18 years of age)
- Admitted in March 2020 for confirmed Covid-19 lung disease (nasopharyngeal smear or sputum with SARS-CoV-2 positive PCR).
Who cannot join
- Patient who has expressed opposition to participation in the study.
- Mild forms of infection that do not require hospitalization,
- Subject under safeguard of justice
- Subject under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales
Strasbourg, 67091
Yves HANSMANN, MD, PhD, 33 3 69 55 09 78, Yves.hansmann@chru-strasbourg.fr
Charlotte KAEUFFER, MD, 33 3 69 55 11 87, Charlotte.kaeuffer@chru-strasbourg.fr
About this study
Official title: Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France
The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care
- Conditions
- Covid-19
- Keywords
- Covid_19, SARS-CoV-2, ARDS, risk factors, infection
- Medical subject headings
- COVID-19, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of risk factors for severity (death or transfer to resuscitation) of Covid-19 infection
Measured: Files analysed retrospectively from March 1st, 2020 to April 15, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start9 Apr 2020
- Primary completion9 Jan 2021 (estimated)
- Study completion9 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362345
- Sponsor's protocol ID
- 7773
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France
- ClinicalTrials.gov ID
- NCT04362345
- Acronym / sponsor ID
- 7773
- Conditions
- Covid-19
- Keywords
- Covid_19, SARS-CoV-2, ARDS, risk factors, infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 9 Jan 2021 (estimated)
- Study completion
- 9 Jan 2021 (estimated)
- First posted
- 24 Apr 2020 (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 aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients with Covid-19
Key inclusion criteria (2 listed)
- Major patient (≥18 years of age)
- Admitted in March 2020 for confirmed Covid-19 lung disease (nasopharyngeal smear or sputum with SARS-CoV-2 positive PCR).
Key exclusion criteria (4 listed)
- Patient who has expressed opposition to participation in the study.
- Mild forms of infection that do not require hospitalization,
- Subject under safeguard of justice
- Subject under guardianship or trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of risk factors for severity (death or transfer to resuscitation) of Covid-19 infection
Time frame: Files analysed retrospectively from March 1st, 2020 to April 15, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
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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.
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, run by University Hospital, Strasbourg, France 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 2 inclusion and 4 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 28 Dec 2020. 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?
Contact Yves HANSMANN, MD, PhD (33 3 69 55 09 78, Yves.hansmann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of risk factors for severity (death or transfer to resuscitation) of Covid-19 infection (time frame: Files analysed retrospectively from March 1st, 2020 to April 15, 2020 will be examined]). 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 28 Dec 2020.