NCT05115045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

November 9, 2021

Last Update Submit

March 31, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Day 60 mortality

    Association between plasmatic SARS-CoV-2 RNA level and mortality

    60 days

Interventions

plasmatic SARS-CoV-2 RNA quantificationDIAGNOSTIC_TEST

plasmatic SARS-CoV-2 RNA was quantified by droplet digital PCR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Sud Ile de France, Hôpital de Melun-Sénart

Melun, 77000, France

Location

Related Publications (1)

  • 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.

    PMID: 32803231BACKGROUND

Study Officials

  • SEBASTIEN JOCHMANS

    GHSIF MELUN

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinical Research Unit

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 10, 2021

Study Start

November 9, 2021

Primary Completion

December 31, 2021

Study Completion

March 1, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

FR(1)