Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 P... | NCT05115045

Studies
Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients

NCT05115045

Sponsor

Hopital of Melun

Status

Completed

Last Update Posted

Apr 3, 2023Actual

Enrollment

122Actual

Phase

Not provided

Conditions

COVID-19 Pneumonia
ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

plasmatic SARS-CoV-2 RNA quantification

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

Mar 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

Nov 9, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Nov 9, 2021

First Submission Date that Met QC Criteria

Nov 9, 2021

First Posted Date

Nov 10, 2021Actual

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

Mar 31, 2023

Last Update Posted Date

Apr 3, 2023Actual

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

Retrospective, observationnal study. Evaluation of the association between plasmatic SARS-CoV-2 RNA and day 60 mortality in ICU adult COVID-19 patients.

Detailed Description

Not provided

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

122Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
plasmatic SARS-CoV-2 RNA quantification	Diagnostic Test	plasmatic SARS-CoV-2 RNA was quantified by droplet digital PCR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Day 60 mortality	Association between plasmatic SARS-CoV-2 RNA level and mortality	60 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age above 18 years
in ICU hospitalization
COVID-19 related pneumonia confirmed by PCR

Exclusion Criteria:

plasmatic SARS-COV-2 RNA quantification not available
patient's refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted in the 34 bed ICU of the Melun-Senart Hospital between march 2021 4th and june 2021 24th meeting eligibility criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SEBASTIEN JOCHMANS	GHSIF MELUN	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Sud Ile de France, Hôpital de Melun-Sénart		Melun		77000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32803231	Background	Veyer D, Kerneis S, Poulet G, Wack M, Robillard N, Taly V, L'Honneur AS, Rozenberg F, Laurent-Puig P, Belec L, Hadjadj J, Terrier B, Pere H. Highly Sensitive Quantification of Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Sheds Light on its Potential Clinical Value. Clin Infect Dis. 2021 Nov 2;73(9):e2890-e2897. doi: 10.1093/cid/ciaa1196.