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NCT05115045 Clinical Trial

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

COVID-19 Pneumonia Clinical Trial

— pRNA-COVID-ICU  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05115045
Other study ID # 2021-MIR-05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 9, 2021
Est. completion date March 1, 2022

Study information
Verified date March 2023
Source Hopital of Melun
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date March 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• plasmatic SARS-CoV-2 RNA quantification
plasmatic SARS-CoV-2 RNA was quantified by droplet digital PCR

Locations
Country Name City State
France Groupe Hospitalier Sud Ile de France, Hôpital de Melun-Sénart Melun

Sponsors (1)
Lead Sponsor Collaborator
Hopital of Melun

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Day 60 mortality Association between plasmatic SARS-CoV-2 RNA level and mortality 60 days
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