Infection ViralNOSO-CORNCT04290780
COVID-19 - Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
An observational study of Infection Viral, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection Viral
- What is being tested?
- nosocomial infection/hospital acquired infection
- How many people
- 2,162 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Mar 2020to 30 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will focus on volunteers, patients, caregivers and health care professionals within the participating hospitals associated with the GABRIEL network. Other hospitals, including french, will be able to integrate with this project on a voluntary basis.
Who may be able to join
- 1 ) Any adult or child or member of the nursing staff from the study participant hospital who presents an infectious syndrome including the following definition :
- 2) Suspect Case:
- Fever above 37.8 ° C if no antipyretics are taken; And or Cough or pharyngeal pain or other symptom suggestive of respiratory infection. AND at least 1 of the following characteristics:
- return from a trip to China, or to a country in which the increase in the incidence of infections in SARS-CoV-2 has been proven;
- close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case;
- Occurring in an establishment having received at least one case of suspected or confirmed infection at SARS-CoV-2.
- Or 3) Confirmed Case: The same clinical definitions, in addition to a positive RT-PCR-type virological diagnostic result specific to SARS-CoV-2
Who cannot join
- Anyone who does not meet the above definition.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service Hygiène, Epidémiologie et Prévention
Lyon, 69003
Service Hygiène, Epidémiologie et Prévention
Lyon, 69004
About this study
Official title: Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported.
The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.
Read more
Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.
The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.
Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.
- Conditions
- Infection Viral
- Being tested
- nosocomial infection/hospital acquired infection
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nosocomial infection/hospital acquired infectionOther
When there is suspicion of a community-acquired case (admission of an infected patient) or nosocomial case (infection of a patient already hospitalized), a case report form including demographic data, medical history, and clinical and biological data on the infectious episode will be completed for each case, either patient, caregivers or health care professionals, presenting clinical signs or symptoms compatible with SARS-CoV-2 infection. The suspected cases will undergo nasopharyngeal swab collection and detection of SARS-CoV-2 in nasopharyngeal swabs will be done by real-time RT-PCR assay.
Hygiene measures applied by the service will be collected using a questionnaire as well as recommendations of the learned societies within the country regarding the risk of infection by coronavirus. In addition, data characterizing the service and hospital will also be collected (specialty, number of beds, number of nurses, doctors, etc.).
What is being measured
The primary outcome is the main question the study is designed to answer.
nosocomial infection
The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start9 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe VANHEMS, MD, PhD, Principal investigator, Service Hygiène, Epidémiologie et Prévention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290780
- Sponsor's protocol ID
- 69HCL20_0214
- Acronym
- NOSO-COR
- Status last verified
- Jan 2022
- First submitted
- 27 Feb 2020
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saadatian-Elahi M, Picot V, Henaff L, Pradel FK, Escuret V, Dananche C, Elias C, Endtz HP, Vanhems P. Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project. BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.
PubMed 33093033Vanhems P. A breath of humanity in the era of Covid-19 vaccine. Vaccine. 2021 Jun 23;39(28):3649. doi: 10.1016/j.vaccine.2021.05.052. Epub 2021 May 24. No abstract available.
PubMed 34053788
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus
- ClinicalTrials.gov ID
- NCT04290780
- Acronym / sponsor ID
- NOSO-COR / 69HCL20_0214
- Conditions
- Infection Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,162 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 2 Mar 2020 (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.
Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported.
The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.
Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.
The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.
Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will focus on volunteers, patients, caregivers and health care professionals within the participating hospitals associated with the GABRIEL network. Other hospitals, including french, will be able to integrate with this project on a voluntary basis.
Key inclusion criteria (7 listed)
- 1 ) Any adult or child or member of the nursing staff from the study participant hospital who presents an infectious syndrome including the following definition :
- Fever above 37.8 ° C if no antipyretics are taken; And or Cough or pharyngeal pain or other symptom suggestive of respiratory infection. AND at least 1 of the following characteristics:
- return from a trip to China, or to a country in which the increase in the incidence of infections in SARS-CoV-2 has been proven;
- close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case;
- Occurring in an establishment having received at least one case of suspected or confirmed infection at SARS-CoV-2.
Key exclusion criteria (1 listed)
- Anyone who does not meet the above definition.
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 |
|---|---|---|
| nosocomial infection/hospital acquired infectionWhen there is suspicion of a community-acquired case (admission of an infected patient) or nosocomial case (infection of a patient already hospitalized), a case report form including demographic data, medical history, and clinical and biological data on the infectious episode will be completed for each case, either patient, caregivers or health care professionals, presenting clinical signs or symptoms compatible with SARS-CoV-2 infection. The suspected cases will undergo nasopharyngeal swab collection and detection of SARS-CoV-2 in nasopharyngeal swabs will be done by real-time RT-PCR assay. Hygiene measures applied by the service will be collected using a questionnaire as well as recommendations of the learned societies within the country regarding the risk of infection by coronavirus. In addition, data characterizing the service and hospital will also be collected (specialty, number of beds, number of nurses, doctors, etc.). | Other | – |
Primary outcome
nosocomial infection
Time frame: At inclusion
The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.
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 2 Sep 2025.
- Results publication: PubMed 33093033Saadatian-Elahi M, Picot V, Henaff L, Pradel FK, Escuret V, Dananche C, Elias C, Endtz HP, Vanhems P. Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project. BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.
- Derived from this study: PubMed 34053788Vanhems P. A breath of humanity in the era of Covid-19 vaccine. Vaccine. 2021 Jun 23;39(28):3649. doi: 10.1016/j.vaccine.2021.05.052. Epub 2021 May 24. No abstract available.
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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.
Philippe VANHEMS, MD, PhD principal investigator
Service Hygiène, Epidémiologie et Prévention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Viral, run by Hospices Civils de Lyon at 2 sites 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 7 inclusion and 1 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
nosocomial infection (time frame: At inclusion). 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 NCT04290780, which also lists 2 linked publications.
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 2 Sep 2025.