COVID-19 PneumoniapRNA-COVID-ICUNCT05115045
Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients
An observational study of COVID-19 Pneumonia and ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, run by Hopital of Melun at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- plasmatic SARS-CoV-2 RNA quantification
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- age above 18 years
- in ICU hospitalization
- COVID-19 related pneumonia confirmed by PCR
Who cannot join
- plasmatic SARS-COV-2 RNA quantification not available
- patient's refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Sud Ile de France, Hôpital de Melun-Sénart
Melun, 77000
About this study
Official title: 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.
- Conditions
- COVID-19 Pneumonia, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
- Being tested
- plasmatic SARS-CoV-2 RNA quantification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasmatic SARS-CoV-2 RNA quantificationDiagnostic test
plasmatic SARS-CoV-2 RNA was quantified by droplet digital PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 60 mortality
Association between plasmatic SARS-CoV-2 RNA level and mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start9 Nov 2021
- Primary completion31 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital of Melun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Jochmans, MD, Hopital of Melun
- Investigators
- SEBASTIEN JOCHMANS, Study director, GHSIF MELUN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115045
- Sponsor's protocol ID
- 2021-MIR-05
- Acronym
- pRNA-COVID-ICU
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32803231
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU)
- ClinicalTrials.gov ID
- NCT05115045
- Acronym / sponsor ID
- pRNA-COVID-ICU / 2021-MIR-05
- Conditions
- COVID-19 Pneumonia, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hopital of MelunUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, observationnal study. Evaluation of the association between plasmatic SARS-CoV-2 RNA and day 60 mortality in ICU adult COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- age above 18 years
- in ICU hospitalization
- COVID-19 related pneumonia confirmed by PCR
Key exclusion criteria (2 listed)
- plasmatic SARS-COV-2 RNA quantification not available
- patient's refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasmatic SARS-CoV-2 RNA quantificationplasmatic SARS-CoV-2 RNA was quantified by droplet digital PCR | Diagnostic test | – |
Primary outcome
Day 60 mortality
Time frame: 60 days
Association between plasmatic SARS-CoV-2 RNA level and mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 32803231Veyer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEBASTIEN JOCHMANS study director
GHSIF MELUN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2, run by Hopital of Melun at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 60 mortality (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05115045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.