ARDSNCT04941092
Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU
An observational study of ARDS and COVID-19 Acute Respiratory Distress Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, COVID-19 Acute Respiratory Distress Syndrome, Influenza
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 10 Jul 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: patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France - hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2
Who may be able to join
- patients hospitalized in ICU
- under mechanical ventilation
- presenting an ARDS according to the Berlin definition
- induced by either influenza or SARS CoV 2
Who cannot join
- pregnant women
- mechanical ventilation>48 hours before admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: a Retrospective, Matched Cohort Study
Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.
- Being tested
- no intervention
- Keywords
- ards
- Medical subject headings
- Influenza, Human, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, retrospective comparison
| Study group | Role | What they receive |
|---|---|---|
| patients with ARDS induced by SARS CoV 2 | Not described Receives: Other: no intervention | |
| patients with ARDS induced by influenza | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: at 28 days
Secondary outcomes (5)
length of stay in ICU
Measured: at 28 days
length of mechanical ventilation
Measured: at 28 days
length of vasopressors
Measured: at 28 days
length of extrarenal epuration
Measured: at 28 days
amount of drugs for sedation
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jun 2021
- Primary completion10 Jul 2021
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lev VOLKOV, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941092
- Sponsor's protocol ID
- 2021PI076
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2021
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: a Retrospective, Matched Cohort Study
- ClinicalTrials.gov ID
- NCT04941092
- Acronym / sponsor ID
- 2021PI076
- Keywords
- ards
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 28 Jun 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.
Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with ARDS induced by SARS CoV 2 | – | Other: no intervention |
| patients with ARDS induced by influenza | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France - hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2
Key inclusion criteria (4 listed)
- patients hospitalized in ICU
- under mechanical ventilation
- presenting an ARDS according to the Berlin definition
- induced by either influenza or SARS CoV 2
Key exclusion criteria (2 listed)
- pregnant women
- mechanical ventilation>48 hours before admission
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 |
|---|---|---|
| no interventionno intervention, retrospective comparison | Other | patients with ARDS induced by SARS CoV 2, patients with ARDS induced by influenza |
Primary outcome
mortality
Time frame: at 28 days
5 secondary outcomes
length of stay in ICU
Time frame: at 28 days
length of mechanical ventilation
Time frame: at 28 days
length of vasopressors
Time frame: at 28 days
length of extrarenal epuration
Time frame: at 28 days
amount of drugs for sedation
Time frame: at 28 days
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 12 Jul 2022.
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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 ARDS and COVID-19 Acute Respiratory Distress Syndrome, run by Central Hospital, Nancy, 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 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: finished, as of the sponsor's last update on 12 Jul 2022. 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?
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?
mortality (time frame: at 28 days). 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 12 Jul 2022.