Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU)

Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU)

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

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia; ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
• Intervention / Treatment: Diagnostic test: plasmatic SARS-CoV-2 RNA quantification

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• France
  • Melun, France, 77000
    • Groupe Hospitalier Sud Ile de France, Hôpital de Melun-Sénart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hopital of Melun
• Investigators: Study Director: SEBASTIEN JOCHMANS, GHSIF Melun

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: 2021-MIR-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No