Covid-19NCT04365764
Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study
An observational study of Covid-19 and ARDS, run by Groupe Hospitalier Pitie-Salpetriere at 2 sites in France.
Trial summary
Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine… Read more about this study
- Who is it for?
- Any age
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Mar 2020to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is cohort-base in routine care, in medical departments.
Who may be able to join
- admitted for severe Covid-19 pneumonia (i.e. requiring O2-support more than 6L/min with SpO2<96%)
Who cannot join
- patients who were previously in ICU
- patients already hospitalized prior to study start date
- patients in palliative care
- lack of consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois
Centre Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil
About this study
Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.
Read the detailed description
Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.
Other outcomes of interest include: acute kidney injury, encephalopathy, need for intensive care unit transfers.
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed to the treatment | Exposure variable will be studied treatment | |
| Not exposer to the treatment (control group) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death and mechanical ventilation
Composite of death and mechanical ventilation (i.e. intubation)
Measured: 14-days follow-up
Secondary outcomes (5)
Death
Death
Measured: 14-days follow-up
Mechanical ventilation
Enabled by intubation
Measured: 14-days follow-up
Composite of death and mechanical ventilation
Composite of death and mechanical ventilation
Measured: 28-days follow-up
World Health Organization score
World Health Organization score
Measured: 14-days follow-up
World Health Organization score
World Health Organization score
Measured: 28-days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start14 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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.
- 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
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Robert Ballanger, Centre Hospitalier Intercommunal Montfermeil-Le Raincy, CMC Ambroise Paré
- Responsible party
- Principal investigator, Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Joe-Elie Salem, MD, PhD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365764
- Sponsor's protocol ID
- CIC1421-20-06
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be available on request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04365764
- Acronym / sponsor ID
- CIC1421-20-06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Robert Ballanger, Centre Hospitalier Intercommunal Montfermeil-Le Raincy, CMC Ambroise Paré
- Study start
- 14 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 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.
Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.
Detailed description
Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.
Other outcomes of interest include: acute kidney injury, encephalopathy, need for intensive care unit transfers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to the treatment | – | –Exposure variable will be studied treatment |
| Not exposer to the treatment (control group) | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is cohort-base in routine care, in medical departments.
Key inclusion criteria (1 listed)
- admitted for severe Covid-19 pneumonia (i.e. requiring O2-support more than 6L/min with SpO2<96%)
Key exclusion criteria (4 listed)
- patients who were previously in ICU
- patients already hospitalized prior to study start date
- patients in palliative care
- lack of consent
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
Composite of death and mechanical ventilation
Time frame: 14-days follow-up
Composite of death and mechanical ventilation (i.e. intubation)
5 secondary outcomes
Death
Time frame: 14-days follow-up
Mechanical ventilation
Time frame: 14-days follow-up
Composite of death and mechanical ventilation
Time frame: 28-days follow-up
World Health Organization score
Time frame: 14-days follow-up
World Health Organization score
Time frame: 28-days follow-up
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 21 Apr 2023.
- Individual participant dataSharing planned: Undecided. IPD may be available on request.
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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.
Joe-Elie Salem, MD, PhD study chair
APHP
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 and ARDS, run by Groupe Hospitalier Pitie-Salpetriere 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 1 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: finished, as of the sponsor's last update on 21 Apr 2023. 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?
Composite of death and mechanical ventilation (time frame: 14-days follow-up). 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 21 Apr 2023.