Sars-CoV2CRASHNCT04412473
COVID-19 Respiratory Distress and Antithrombotic Drugs in Subject's Habits
An observational study of Sars-CoV2, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to Jun 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
- Adult, Older adult
Study population: Adult Partients hospitalised in HUS or GHRMSA for COVID-19 with diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record
Who may be able to join
- Major Subject (≥18 years)
- Subject hospitalised in HUS or GHRMSA for COVID-19
- The diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record
- Subjects who, after being informed, do not wish to have their data reused for the purposes of this research
Who cannot join
- Subject who expressed opposition to participating in the study
- Subject under guardianship or trusteeship
- Subject under safeguard of justice
- Patient hospitalized in a geriatric service or in a ward not labeled COVID (surgery, oncology,...) or in a short-term hospitalization unit without transfer to another service.
- Serious patient on admission to the emergency room and recused from resuscitation.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Médecine Intensive et Réanimation
Strasbourg, 67091
Vincent CASTELAIN, MD, PhD, 33 3 88 12 82 69 /, Vincent.CASTELAIN@chru-strasbourg.fr
Vincent CASTELAIN, MD, PhD
About this study
Official title: COVID-19 Respiratory Distress and Antithrombotic Drugs inSubject's Habits
Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. The general pathophysiology of ARDS, the vascular tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery thromboses in resuscitation and the encouraging investigation of antithrombotics in general ARDS
- Conditions
- Sars-CoV2
- Keywords
- Sars-CoV2, Covid-19, Antithrombotic treatments, ARDS, Hypoxemia, Thrombosis, Pulmonary arteries, Endothelial
- Medical subject headings
- COVID-19, Hypoxia, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start30 Apr 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies 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
- Retrospective
- Enrolment
- 1,000 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
- NCT04412473
- Sponsor's protocol ID
- 7837
- Acronym
- CRASH
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 11 Jan 2021
- 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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Respiratory Distress and Antithrombotic Drugs inSubject's Habits
- ClinicalTrials.gov ID
- NCT04412473
- Acronym / sponsor ID
- CRASH / 7837
- Conditions
- Sars-CoV2
- Keywords
- Sars-CoV2, Covid-19, Antithrombotic treatments, ARDS, Hypoxemia, Thrombosis, Pulmonary arteries, Endothelial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Jun 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.
Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. The general pathophysiology of ARDS, the vascular tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery thromboses in resuscitation and the encouraging investigation of antithrombotics in general ARDS
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult Partients hospitalised in HUS or GHRMSA for COVID-19 with diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record
Key inclusion criteria (4 listed)
- Major Subject (≥18 years)
- Subject hospitalised in HUS or GHRMSA for COVID-19
- The diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record
- Subjects who, after being informed, do not wish to have their data reused for the purposes of this research
Key exclusion criteria (5 listed)
- Subject who expressed opposition to participating in the study
- Subject under guardianship or trusteeship
- Subject under safeguard of justice
- Patient hospitalized in a geriatric service or in a ward not labeled COVID (surgery, oncology,...) or in a short-term hospitalization unit without transfer to another service.
- Serious patient on admission to the emergency room and recused from resuscitation.
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
Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
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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 Sars-CoV2, 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 4 inclusion and 5 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 11 Jan 2021. 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 Vincent CASTELAIN, MD, PhD (33 3 88 12 82 69, Vincent.CASTELAIN@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19 (time frame: 1 month). 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 11 Jan 2021.