COVIDNCT04366206
Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est
An observational study of COVID and SARS-CoV 2, run by Centre Hospitalier Intercommunal Robert Ballanger at 2 sites in France.
Trial summary
Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID, SARS-CoV 2
- How many people
- 143 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Mar 2020to 31 Jul 2020
- How long will I take part?
- 14 Weeks
- 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: All patients hospitalized for Covid-19 may be eligible to join this cohort study
Who may be able to join
- hospitalized for Covid-19
- severe pneumonia defined as pulse O2 < 96% despite > 6L/min
Who cannot join
- lack of consent
- palliative care patients
- patients in ICU
- patients transferred from ICU
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois, 93600
Hélène Gros, MD, 01 49 36 71 23 ext. +33, helene.gros@ght-gpne.fr
Benjamin Rossi, MD, 01 49 36 71 23 ext. +33, benjamin.rossi@ght-gpne.fr
- Not yet recruiting
Groupe Hospitalier Pitie Salpetriere
Paris, 75013
Lee S Nguyen, MD, PhDc, 01 42 17 85 31 ext. +33, nguyen.lee@icloud.com
About this study
Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).
This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19, by analyzing associations between treatments and outcomes.
All data are collected in electronical records during routine practice.
Read the detailed description
Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).
This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19.
Risk factors which will be studied include: baseline characteristics such as medical history and drugs with corresponding administration protocols.
Main outcomes include all-cause mortality, need for mechanical ventilation, for ICU transfer and all relevant biological syndromes.
All data are collected in electronical records during routine practice and additional data may be collected retrospectively.
- Conditions
- COVID, SARS-CoV 2
- Keywords
- covid-19, SARS-Cov-2
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| Patients exposed to the study variable | Depending on the studied variable (treatment or risk factor) | |
| Patients not exposed to the study variable | Depending on the studied variable (treatment or risk factor) |
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
Measured: At 14-days follow-up
Secondary outcomes (8)
Need for mechanical ventilation
Need for mechanical ventilation
Measured: At 14-days follow-up
Death
All-cause mortality
Measured: At 14-days follow-up
Acute kidney injury
As defined by AKIN
Measured: At 14-days follow-up
Acute respiratory distress syndrome
As defined by Berlin criteria: P/F ratio below 200, with PEEP > +5 cmH20, radiologic findings compatible with ARDS and not explained by heart failure, occurring within 7 days of an acute pulmonary or non-pulmonary aggression.
Measured: At 14-days follow-up
Cardiac arrhythmia and conduction disorder
Documented by EKG monitoring
Measured: At 14-days follow-up
Composite of death and mechanical ventilation
Composite of death and mechanical ventilation
Measured: Up to 60 days after inclusion
60-days mortality
All cause mortality at 60 days follow-up whenever possible
Measured: Up to 60 days after inclusion
60-days mechanical ventilation
If patient was mechanically ventilated within 60 days of inclusion
Measured: Up to 60 days after inclusion
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 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (estimated)
- Target duration
- 14 Weeks
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Robert Ballanger
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Principal investigator, Dr. Hélène GROS, Centre Hospitalier Intercommunal Robert Ballanger
- Investigators
- Hélène Gros, MD, Study director, Robert Ballanger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366206
- Sponsor's protocol ID
- GHTRB-2020-01
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est
- ClinicalTrials.gov ID
- NCT04366206
- Acronym / sponsor ID
- GHTRB-2020-01
- Conditions
- COVID, SARS-CoV 2
- Keywords
- covid-19, SARS-Cov-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal Robert BallangerUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- 14 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- 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.
Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).
This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19, by analyzing associations between treatments and outcomes.
All data are collected in electronical records during routine practice.
Detailed description
Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).
This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19.
Risk factors which will be studied include: baseline characteristics such as medical history and drugs with corresponding administration protocols.
Main outcomes include all-cause mortality, need for mechanical ventilation, for ICU transfer and all relevant biological syndromes.
All data are collected in electronical records during routine practice and additional data may be collected retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients exposed to the study variable | – | –Depending on the studied variable (treatment or risk factor) |
| Patients not exposed to the study variable | – | –Depending on the studied variable (treatment or risk factor) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients hospitalized for Covid-19 may be eligible to join this cohort study
Key inclusion criteria (2 listed)
- hospitalized for Covid-19
- severe pneumonia defined as pulse O2 < 96% despite > 6L/min
Key exclusion criteria (4 listed)
- lack of consent
- palliative care patients
- patients in ICU
- patients transferred from ICU
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: At 14-days follow-up
Composite of death and mechanical ventilation
8 secondary outcomes
Need for mechanical ventilation
Time frame: At 14-days follow-up
Death
Time frame: At 14-days follow-up
Acute kidney injury
Time frame: At 14-days follow-up
Acute respiratory distress syndrome
Time frame: At 14-days follow-up
Cardiac arrhythmia and conduction disorder
Time frame: At 14-days follow-up
Composite of death and mechanical ventilation
Time frame: Up to 60 days after inclusion
60-days mortality
Time frame: Up to 60 days after inclusion
60-days mechanical ventilation
Time frame: Up to 60 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Hélène Gros, MD study director
Robert Ballanger
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 and SARS-CoV 2, run by Centre Hospitalier Intercommunal Robert Ballanger 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 2 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: status not confirmed, as of the sponsor's last update on 28 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Gros, MD (01 49 36 73 67 ext. +33, helene.gros@ght-gpne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death and mechanical ventilation (time frame: At 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 28 Apr 2020.