COVID-19NCT04376879
Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)
An observational study of COVID-19, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Data monitoring for 48h within the first 24 hours of admission for COVID-19
- How many people
- 301 participants
- Where
- 2 sitesFrance
- Study dates
- 16 May 2020to 31 May 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: Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours
Who may be able to join
- Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours,
- Patients requiring oxygen therapy,
- Age ≥ 18 years old.
Who cannot join
- Patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect.,
- Patients who can not be intubated for medical reasons,
- Pregnant women, parturient women or nursing mothers ,
- Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard),
- Adults person who is unable to give consent and who is not subject to a legal protection measure,
- Persons deprived of their liberty by a judicial or administrative decision,
- Persons subject to psychiatric care under duress.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Louis Mourier hospital (AP-HP)
Colombes, 92700
Brabois Hospital (CHRU de Nancy)
Vandœuvre-lès-Nancy, 54500
About this study
One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.
The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.
The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation
- Conditions
- COVID-19
- Being tested
- Data monitoring for 48h within the first 24 hours of admission for COVID-19
- 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 monitoring for 48h within the first 24 hours of admission for COVID-19Other
The admission variables and those constituting the predictive score (blood pressure, temperature, oxygenotherapy, biological analysis...) will be collected for 48 hours after enrolment (i.e within the first 24 hours of admission )
| Study group | Role | What they receive |
|---|---|---|
| Step 1: creation of the score | Cohort for the creation of clinical-biological score to predict the risk of intubation in COVID-19 Receives: Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19 | |
| Step 2: validation of the score | Cohort for the validation of clinical-biological score to predict the risk of intubation in COVID-19 Receives: Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of intubations in COVID-19 patients initially hospitalised in wards
Primary outcome measure for the creation of the predictive score
Measured: up to 1 month
Secondary outcomes (1)
the number of intubations in COVID-19 patients initially hospitalised in wards.
Secondary endpoints for validation of the predictive score
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start16 May 2020
- Primary completion31 May 2021
- Study completion31 May 2021
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 Central Hospital, Nancy, 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine KIMMOUN, MD-PhD, Study chair, CHRU de NANCYJean Damien RICARD, MD-PhD, Study chair, AP-HP, Louis Mourier HospitalJulie JOSSE, PhD, Study chair, Institut National de Recherche en Informatique et en AutomatiquePatrick ROSSIGNOL, MD-PhD, Study chair, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376879
- Sponsor's protocol ID
- 2020-A01076-33
- Status last verified
- Aug 2021
- First submitted
- 4 May 2020
- Last updated
- 10 Sep 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 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Need for Intubation in Hospitalised COVID-19 Patients (PRED ICU COVID19)
- ClinicalTrials.gov ID
- NCT04376879
- Acronym / sponsor ID
- 2020-A01076-33
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 16 May 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 6 May 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.
One of the main challenges of the health crisis caused by the COVID-19 epidemic is the availability of beds in intensive care units (ICUs) and, more importantly, the need for invasive mechanical ventilation (IVM) because the ICUs are currently reserved for intubated patients.
The experiences of both China and Italy indicate that a certain number of COVID-19 patients will require mechanical ventilation. However, the limited number of resuscitation beds and ventilators requires strict use of these scarce resources. As a significant proportion about 5% to 10%, of patients initially admitted to hospital with COVID-19 will require ventilation, it is essential to anticipate their need for resuscitation to improve the rare resource of beds and ventilator shortages in intensive care units.
The hypothesis of the study is that, in proven or suspected hospitalised and oxygen-requiring COVID-19 patients, an early predictive clinical score, calculated over the three first days of admission may allow for an earlier identification of patients who will require intubation and transfer to an intensive care unit for orotracheal intubation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step 1: creation of the score | – | Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19Cohort for the creation of clinical-biological score to predict the risk of intubation in COVID-19 |
| Step 2: validation of the score | – | Other: Data monitoring for 48h within the first 24 hours of admission for COVID-19Cohort for the validation of clinical-biological score to predict the risk of intubation in COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours
Key inclusion criteria (3 listed)
- Proven or expected COVID-19 patients hospitalised in a non-intensive care unit for less than 24 hours,
- Patients requiring oxygen therapy,
- Age ≥ 18 years old.
Key exclusion criteria (7 listed)
- Patients who are opposed to taking part in the study and who are opposed to the collection and use of the data that the study aims to collect.,
- Patients who can not be intubated for medical reasons,
- Pregnant women, parturient women or nursing mothers ,
- Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard),
- Adults person who is unable to give consent and who is not subject to a legal protection measure,
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 monitoring for 48h within the first 24 hours of admission for COVID-19The admission variables and those constituting the predictive score (blood pressure, temperature, oxygenotherapy, biological analysis...) will be collected for 48 hours after enrolment (i.e within the first 24 hours of admission ) | Other | Step 1: creation of the score, Step 2: validation of the score |
Primary outcome
the number of intubations in COVID-19 patients initially hospitalised in wards
Time frame: up to 1 month
Primary outcome measure for the creation of the predictive score
1 secondary outcome
the number of intubations in COVID-19 patients initially hospitalised in wards.
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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.
Antoine KIMMOUN, MD-PhD study chair
CHRU de NANCY
Jean Damien RICARD, MD-PhD study chair
AP-HP, Louis Mourier Hospital
Julie JOSSE, PhD study chair
Institut National de Recherche en Informatique et en Automatique
2 sites 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 Central Hospital, Nancy, France at 2 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the number of intubations in COVID-19 patients initially hospitalised in wards (time frame: up to 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 10 Sep 2021.