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

• Sponsor: Hopital of Melun (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05115045
• Collaborator: (none)
• Enrollment: 125
• Anticipated Duration (Months): 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia; ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2	Diagnostic Test: plasmatic SARS-CoV-2 RNA quantification

Study Design

• Study Type: Observational
• Anticipated Enrollment: 125 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU)
• Anticipated Study Start Date: Nov 9, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Outcome Measures

Primary Outcome Measures

1. Day 60 mortality [60 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hopital of Melun

Investigators

• Study Director: SEBASTIEN JOCHMANS, GHSIF MELUN

Study Documents (Full-Text)

None provided.

More Information

Publications

• Veyer D, Kernéis S, Poulet G, Wack M, Robillard N, Taly V, L'Honneur AS, Rozenberg F, Laurent-Puig P, Bélec L, Hadjadj J, Terrier B, Péré 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.

• Responsible Party: Sebastien Jochmans, MD, Head of Clinical Research Unit, Hopital of Melun
• ClinicalTrials.gov Identifier: NCT05115045
• Other Study ID Numbers: 2021-MIR-05
• First Posted: Nov 10, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Nov 10, 2021