Effect of Treatments in Patients Hospitalized for Severe... | NCT04365764

Studies
Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study

NCT04365764

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Status

Completed

Last Update Posted

Apr 21, 2023Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Covid-19
ARDS
Pneumonia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Apr 25, 2020

First Submission Date that Met QC Criteria

Apr 25, 2020

First Posted Date

Apr 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

Apr 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lee S Nguyen, Study coordinator, Groupe Hospitalier Pitie-SalpetrierePrincipal Investigator

Lead Sponsor

Groupe Hospitalier Pitie-SalpetriereOTHER

Collaborators

Name	Class
Centre Hospitalier Intercommunal Robert Ballanger	OTHER
Centre Hospitalier Intercommunal Montfermeil-Le Raincy	UNKNOWN
CMC Ambroise Paré	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

Detailed Description

Other outcomes of interest include: acute kidney injury, encephalopathy, need for intensive care unit transfers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed to the treatment		Exposure variable will be studied treatment
Not exposer to the treatment (control group)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of death and mechanical ventilation	Composite of death and mechanical ventilation (i.e. intubation)	14-days follow-up

Secondary Outcomes

Measure	Description	Time Frame
Death	Death	14-days follow-up
Mechanical ventilation	Enabled by intubation	14-days follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

admitted for severe Covid-19 pneumonia (i.e. requiring O2-support more than 6L/min with SpO2<96%)

Exclusion Criteria:

patients who were previously in ICU
patients already hospitalized prior to study start date
patients in palliative care
lack of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population is cohort-base in routine care, in medical departments.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joe-Elie Salem, MD, PhD	APHP	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Intercommunal Robert Ballanger		Aulnay-sous-Bois			France
Centre Hospitalier Intercommunal Le Raincy-Montfermeil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD may be available on request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011014	Pneumonia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided