SARS-CoV-2 InfectionSpread-COVIDNCT05567419
SARS-CoV-2 in Stools Compared to Respiratory Viral Strains.
An observational study of SARS-CoV-2 Infection, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Biological assays
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2022to May 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) in Infectious diseases department and Intensive care unit, whatever the severity of the clinical form. n=30 Sampling dates: COVID-19 diagnostics day (d0), day-2, day-4, day-end of hospitalization, day-post hospitalization
Who may be able to join
- Age: men or women of 18 years-old or more
- Clinical signs: hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) (in: Infectious diseases department, Intensive care unit), whatever the severity of the clinical form.
- The subject gave his/her informed and writen consent, after complete explanations on the research schedule.
- Compulsory affiliation to a social security scheme.
- Previous medical examination, when a patient is admitted to the hospital, according to good clinical practices.
Who cannot join
- Subject corresponding to articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public health code:
- pregnant woman, parturient or breastfeeding woman
- Minor person
- Person of full age under guardianship, curatorship, safeguard of justice
- Woman who wants to be pregnant during the study period
- Person in psychiatric care - articles L. 3212-1 and L. 3213-1 who do not fall under the article L. 1121-8 (without consent hospitalisation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.
The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Biological assays
- Keywords
- COVID-19; SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological assaysDiagnostic test
PCR and NGS-WGS on stools and respiratory samples
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 dynamics in stools.
Evolutive SARS-CoV-2 dynamics in stools compared to respiratory tract: molecular quantification (ddPCR) of SARS-CoV-2 variants genome in stools, compared to the viral quantification in respiratory samples.
Measured: 30 monthes
Secondary outcomes (2)
SARS-CoV-2 in stools compared to the virus in wastewaters.
SARS-CoV-2 in stools compared to wastewaters: molecular quantification (ddPCR) of SARS-CoV-2 variants genome in stools, compared to the viral quantification in wastewater samples.
Measured: 30 monthes
Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.
SARS-CoV-2 load in stools and COVID-19 global frequency: correlation between SARS-CoV-2 load in stools by ddPCR and COVID-19 incidence in the neighboring global inhabitants population.
Measured: 30 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelyne Schvoerer, Central Hospital, Nancy, France
- Investigators
- Evelyne ES Schvoerer, Prof., Principal investigator, University hospital Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567419
- Sponsor's protocol ID
- 2022-A00731-42
- Acronym
- Spread-COVID
- Status last verified
- Oct 2022
- First submitted
- 24 May 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.
- ClinicalTrials.gov ID
- NCT05567419
- Acronym / sponsor ID
- Spread-COVID / 2022-A00731-42
- Conditions
- SARS-CoV-2 Infection
- Keywords
- COVID-19; SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Oct 2022 (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.
The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) in Infectious diseases department and Intensive care unit, whatever the severity of the clinical form. n=30 Sampling dates: COVID-19 diagnostics day (d0), day-2, day-4, day-end of hospitalization, day-post hospitalization
Key inclusion criteria (5 listed)
- Age: men or women of 18 years-old or more
- Clinical signs: hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) (in: Infectious diseases department, Intensive care unit), whatever the severity of the clinical form.
- The subject gave his/her informed and writen consent, after complete explanations on the research schedule.
- Compulsory affiliation to a social security scheme.
- Previous medical examination, when a patient is admitted to the hospital, according to good clinical practices.
Key exclusion criteria (6 listed)
- Subject corresponding to articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public health code:
- Woman who wants to be pregnant during the study period
- Person in psychiatric care - articles L. 3212-1 and L. 3213-1 who do not fall under the article L. 1121-8 (without consent hospitalisation)
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 |
|---|---|---|
| Biological assaysPCR and NGS-WGS on stools and respiratory samples | Diagnostic test | – |
Primary outcome
SARS-CoV-2 dynamics in stools.
Time frame: 30 monthes
Evolutive SARS-CoV-2 dynamics in stools compared to respiratory tract: molecular quantification (ddPCR) of SARS-CoV-2 variants genome in stools, compared to the viral quantification in respiratory samples.
2 secondary outcomes
SARS-CoV-2 in stools compared to the virus in wastewaters.
Time frame: 30 monthes
Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.
Time frame: 30 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Evelyne ES Schvoerer, Prof. principal investigator
University hospital Nancy, France
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 SARS-CoV-2 Infection, run by Central Hospital, Nancy, France 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El Mehdi MS Siaghy (+33383155276, m.siaghi@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 dynamics in stools. (time frame: 30 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2022.