Acute Respiratory Distress Syndrome Secondary to Covid-19CoCovSDRANCT04586114
Effect of Corticosteroid Treatment on Prognosis in ARDS Secondary to Covid-19
An observational study of Acute Respiratory Distress Syndrome Secondary to Covid-19, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome Secondary to Covid-19
- What is being tested?
- Corticosteroids and Derivatives
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 31 Dec 2020
- 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: Patient more than 18 years old hospitalized in ICU from 01/03/2020 to 30/04/2020 with acute respiratory distress syndrome secondary to Sars-Cov-2 infection without any corticosteroid treatment before admission, excluding patients with mechanical ventilation more than 48 hours before admission and patients transferred to other ICU.
Who may be able to join
- ICU hospitalized with acute respiratory distress syndrome secondary to Sars-Cov-2 infection diagnosed by PCR test
- Hospitalized from 01/03/2020 to 30/04/2020
Who cannot join
- Mechanical ventilation more than 48 hours at admission
- Transfert to another ICU during stay for bed management
- Corticosteroid treatment at admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19
Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.
- Being tested
- Corticosteroids and Derivatives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroids and DerivativesDrug
Any systemic corticosteroid treatment administrated during ICU stay
| Study group | Role | What they receive |
|---|---|---|
| Early corticosteroid | Corticosteroid treatment within first seven days after ICU admission Receives: Drug: Corticosteroids and Derivatives | |
| Late corticosteroid | Corticosteroid treatment later than seventh day's after ICU admission Receives: Drug: Corticosteroids and Derivatives | |
| No corticosteroid | No corticosteroid treatment during ICU stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in ICU
Mortality rates in ICU in each group
Measured: within ICU stay, on average 15 days
Secondary outcomes (4)
Mortality d28
mortality at day 28 after ICU admission
Measured: 28 days
acquired infections incidence
cumulative incidence of infection acquired during ICU stay
Measured: 28 days
antibiotics duration
number of treatment days with antibiotics during ICU stay
Measured: 28 days
mechanical ventilation duration
number of days of treatment by mechanical ventilation during ICU stay
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Mar 2020
- Primary completion31 May 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome Secondary to 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien GIBOT, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586114
- Sponsor's protocol ID
- 2020PI109
- Acronym
- CoCovSDRA
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19
- ClinicalTrials.gov ID
- NCT04586114
- Acronym / sponsor ID
- CoCovSDRA / 2020PI109
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Oct 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.
Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early corticosteroid | – | Drug: Corticosteroids and DerivativesCorticosteroid treatment within first seven days after ICU admission |
| Late corticosteroid | – | Drug: Corticosteroids and DerivativesCorticosteroid treatment later than seventh day's after ICU admission |
| No corticosteroid | – | –No corticosteroid treatment during ICU stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient more than 18 years old hospitalized in ICU from 01/03/2020 to 30/04/2020 with acute respiratory distress syndrome secondary to Sars-Cov-2 infection without any corticosteroid treatment before admission, excluding patients with mechanical ventilation more than 48 hours before admission and patients transferred to other ICU.
Key inclusion criteria (2 listed)
- ICU hospitalized with acute respiratory distress syndrome secondary to Sars-Cov-2 infection diagnosed by PCR test
- Hospitalized from 01/03/2020 to 30/04/2020
Key exclusion criteria (3 listed)
- Mechanical ventilation more than 48 hours at admission
- Transfert to another ICU during stay for bed management
- Corticosteroid treatment at 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 |
|---|---|---|
| Corticosteroids and DerivativesAny systemic corticosteroid treatment administrated during ICU stay | Drug | Early corticosteroid, Late corticosteroid |
Primary outcome
Mortality in ICU
Time frame: within ICU stay, on average 15 days
Mortality rates in ICU in each group
4 secondary outcomes
Mortality d28
Time frame: 28 days
acquired infections incidence
Time frame: 28 days
antibiotics duration
Time frame: 28 days
mechanical ventilation duration
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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.
Sebastien GIBOT principal investigator
Central Hospital, Nancy, France
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 Acute Respiratory Distress Syndrome Secondary to Covid-19, 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 2 inclusion and 3 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 19 Oct 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?
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 in ICU (time frame: within ICU stay, on average 15 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 19 Oct 2020.