SARS-Cov2COVID-19NCT04913701
COVID-19 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility
An observational study of SARS-Cov2, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
The recent SARS-CoV2 pandemic has highlighted that the transmission of the virus within health care facilities plays a fundamental role in its propagation and, therefore, in the increase in COVID-19 cases registered among patients and healthcare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-Cov2
- What is being tested?
- Observation group 1
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 21 Mar 2020to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study will be on healthcare workers in direct contact with patients (pts). Surveillance will be done on new admitted pts to evaluate prevalence of infection among pts in pulmonary, or cardiac rehabilitation. Data will allow to reconstruct eventual transmission and compare values observed in healthcare and real life. Random samples will be done in subjects from the population without obvious risk factors. Study will have 3 groups: * 200-300 healthcare workers in direct patients contact, incl. staff at registration desk. 100-200 pts admitted to rehabilitation at the Institute, referred from other health facilities will be enrolled in the study. * 100 volunteers in Real-life will be other employees, staff not in contact with patients
Who may be able to join
- Patients/Participants > 18 years
- Subjects who agree with the study signing the informed consent
Who cannot join
- Age <18 years;
- Pregnancy in progress;
- Simultaneous participation in another clinical study
- Ongoing immunosuppressive therapy or during the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study for SARS-Cov2 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility
The recent SARS-CoV2 pandemic has highlighted that the transmission of the virus within health care facilities plays a fundamental role in its propagation and, therefore, in the increase in COVID-19 cases registered among patients and healthcare workers.
This study, original for the current lack of data on nosocomial transmission mechanisms compared to what happens in the community, proposes to conduct a study in patients, health workers and people in real-life setting.
The study will be monocentric and performed at the San Raffaele Pisana Institute in Rome, that is able to guarantee the necessary number and the right case-mix that will allow to evaluate any possible correlations between infection and pre-existing disease.
Read the detailed description
Furthermore, hospitals, especially those dedicated to chronic patients, as well as other communities that are not completely closed (such as school and work communities), are also at greater risk of small outbreaks that also affect healthcare professionals.
It is therefore necessary to carry out periodic checks on all healthcare professionals who work in healthcare facilities both to ensure their health and avoid the risk of possible contamination and to prevent the possible transmission of infection from the community to the hospital.
Another essential aspect to prevent infection in such facilities is the control of colonization in admitted patients.
Negativity from SARS-CoV2 should be carefully monitored in these patients prior to their placement in different departments.
On this basis, the study aims to determine the presence of SARS-CoV2 by monitoring with serial nasopharyngeal swabs carried out on healthcare professionals working within the facility and on new patients admitted.
In order to exclude the possibility of false negatives due to low viral load found in the early stages of infection (incubation time) or any exposure that may occur in the days following the execution of the swab, the study will i provide for the repetition of the swab examination, 3 times, at weekly intervals.
In order to verify the correspondence between the presence of IgM and IgG antibodies against the virus and the positivity to the swabs, the healthcare professionals and patients who undergoing nasopharyngeal swab will be previously subjected to the rapid antibody detection test (prick test for IgG and IgM).
- Conditions
- SARS-Cov2
- Being tested
- Observation group 1
- Keywords
- SARS-Cov2, Covid-19, Epidemiological surveillance, Observational study, Healtcare workers, Real-life, Rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation group 1Other
Subjects will be followed with 3 swabs and serological test
| Study group | Role | What they receive |
|---|---|---|
| 1 - Health workers | A total number of 200-300 healthcare workers, exposed to close contact with patients, will be asked to participate to the study and will be asked to sign the informed consent. Receives: Other: Observation group 1 | |
| 2 - Patients | A total number of 100-200 patients admitted to the rehabilitation facility, referred from other healthcare facilities or from their own home, will be asked to participate to the study. Receives: Other: Observation group 1 | |
| 3 - Real life participants | A total number of 100 real-life participants, will be represented by volunteers (other employees, staff not in contact with patients Receives: Other: Observation group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with positive RT-PCR against SARS-CoV2
All subjects will have 3 swabs done and analyzed
Measured: 15 days
Secondary outcomes (1)
Number of participants with qualitative IgM/IgG positive results
All subjects will have 1 blood pick-test
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start21 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SARS-Cov2Studies 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
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Tomino, PhD, Study director, IRCCS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913701
- Sponsor's protocol ID
- RP 20/09 main
- Acronym
- COVID-19
- Status last verified
- Jun 2023
- First submitted
- 31 May 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao WJ, Li LM. [Advances on presymptomatic or asymptomatic carrier transmission of COVID-19]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Apr 10;41(4):485-488. doi: 10.3760/cma.j.cn112338-20200228-00207. Chinese.
PubMed 32141279Gates B. Responding to Covid-19 - A Once-in-a-Century Pandemic? N Engl J Med. 2020 Apr 30;382(18):1677-1679. doi: 10.1056/NEJMp2003762. Epub 2020 Feb 28. No abstract available.
PubMed 32109012Heymann DL. Data sharing and outbreaks: best practice exemplified. Lancet. 2020 Feb 15;395(10223):469-470. doi: 10.1016/S0140-6736(20)30184-7. Epub 2020 Jan 24. No abstract available.
PubMed 31986258Hellewell J, Abbott S, Gimma A, Bosse NI, Jarvis CI, Russell TW, Munday JD, Kucharski AJ, Edmunds WJ; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Funk S, Eggo RM. Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts. Lancet Glob Health. 2020 Apr;8(4):e488-e496. doi: 10.1016/S2214-109X(20)30074-7. Epub 2020 Feb 28.
PubMed 32119825Huh S. How to train health personnel to protect themselves from SARS-CoV-2 (novel coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof. 2020 Jan;17:10. doi: 10.3352/jeehp.2020.17.10. Epub 2020 Mar 7. No abstract available.
PubMed 32150796Jones DS. History in a Crisis - Lessons for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1681-1683. doi: 10.1056/NEJMp2004361. Epub 2020 Mar 12. No abstract available.
PubMed 32163699Lipsitch M, Swerdlow DL, Finelli L. Defining the Epidemiology of Covid-19 - Studies Needed. N Engl J Med. 2020 Mar 26;382(13):1194-1196. doi: 10.1056/NEJMp2002125. Epub 2020 Feb 19. No abstract available.
PubMed 32074416Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.
PubMed 32003551Reusken CBEM, Broberg EK, Haagmans B, Meijer A, Corman VM, Papa A, Charrel R, Drosten C, Koopmans M, Leitmeyer K; EVD-LabNet and ERLI-Net. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill. 2020 Feb;25(6):2000082. doi: 10.2807/1560-7917.ES.2020.25.6.2000082. Epub 2020 Feb 11.
PubMed 32046815Xiao Y, Torok ME. Taking the right measures to control COVID-19. Lancet Infect Dis. 2020 May;20(5):523-524. doi: 10.1016/S1473-3099(20)30152-3. Epub 2020 Mar 5. No abstract available.
PubMed 32145766Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
PubMed 32074444Xu B, Kraemer MUG; Open COVID-19 Data Curation Group. Open access epidemiological data from the COVID-19 outbreak. Lancet Infect Dis. 2020 May;20(5):534. doi: 10.1016/S1473-3099(20)30119-5. Epub 2020 Feb 19. No abstract available.
PubMed 32087115
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for SARS-Cov2 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility
- ClinicalTrials.gov ID
- NCT04913701
- Acronym / sponsor ID
- COVID-19 / RP 20/09 main
- Conditions
- SARS-Cov2
- Keywords
- SARS-Cov2, Covid-19, Epidemiological surveillance, Observational study, Healtcare workers, Real-life, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Jun 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.
The recent SARS-CoV2 pandemic has highlighted that the transmission of the virus within health care facilities plays a fundamental role in its propagation and, therefore, in the increase in COVID-19 cases registered among patients and healthcare workers.
This study, original for the current lack of data on nosocomial transmission mechanisms compared to what happens in the community, proposes to conduct a study in patients, health workers and people in real-life setting.
The study will be monocentric and performed at the San Raffaele Pisana Institute in Rome, that is able to guarantee the necessary number and the right case-mix that will allow to evaluate any possible correlations between infection and pre-existing disease.
Detailed description
Furthermore, hospitals, especially those dedicated to chronic patients, as well as other communities that are not completely closed (such as school and work communities), are also at greater risk of small outbreaks that also affect healthcare professionals.
It is therefore necessary to carry out periodic checks on all healthcare professionals who work in healthcare facilities both to ensure their health and avoid the risk of possible contamination and to prevent the possible transmission of infection from the community to the hospital.
Another essential aspect to prevent infection in such facilities is the control of colonization in admitted patients.
Negativity from SARS-CoV2 should be carefully monitored in these patients prior to their placement in different departments.
On this basis, the study aims to determine the presence of SARS-CoV2 by monitoring with serial nasopharyngeal swabs carried out on healthcare professionals working within the facility and on new patients admitted.
In order to exclude the possibility of false negatives due to low viral load found in the early stages of infection (incubation time) or any exposure that may occur in the days following the execution of the swab, the study will i provide for the repetition of the swab examination, 3 times, at weekly intervals.
In order to verify the correspondence between the presence of IgM and IgG antibodies against the virus and the positivity to the swabs, the healthcare professionals and patients who undergoing nasopharyngeal swab will be previously subjected to the rapid antibody detection test (prick test for IgG and IgM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Health workers | – | Other: Observation group 1A total number of 200-300 healthcare workers, exposed to close contact with patients, will be asked to participate to the study and will be asked to sign the informed consent. |
| 2 - Patients | – | Other: Observation group 1A total number of 100-200 patients admitted to the rehabilitation facility, referred from other healthcare facilities or from their own home, will be asked to participate to the study. |
| 3 - Real life participants | – | Other: Observation group 1A total number of 100 real-life participants, will be represented by volunteers (other employees, staff not in contact with patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study will be on healthcare workers in direct contact with patients (pts). Surveillance will be done on new admitted pts to evaluate prevalence of infection among pts in pulmonary, or cardiac rehabilitation. Data will allow to reconstruct eventual transmission and compare values observed in healthcare and real life. Random samples will be done in subjects from the population without obvious risk factors. Study will have 3 groups: * 200-300 healthcare workers in direct patients contact, incl. staff at registration desk. 100-200 pts admitted to rehabilitation at the Institute, referred from other health facilities will be enrolled in the study. * 100 volunteers in Real-life will be other employees, staff not in contact with patients
Key inclusion criteria (2 listed)
- Patients/Participants > 18 years
- Subjects who agree with the study signing the informed consent
Key exclusion criteria (4 listed)
- Age <18 years;
- Pregnancy in progress;
- Simultaneous participation in another clinical study
- Ongoing immunosuppressive therapy or during the last month
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 |
|---|---|---|
| Observation group 1Subjects will be followed with 3 swabs and serological test | Other | 1 - Health workers, 2 - Patients, 3 - Real life participants |
Primary outcome
Number of participants with positive RT-PCR against SARS-CoV2
Time frame: 15 days
All subjects will have 3 swabs done and analyzed
1 secondary outcome
Number of participants with qualitative IgM/IgG positive results
Time frame: 15 days
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 26 Jun 2023.
- Background: PubMed 32141279Gao WJ, Li LM. [Advances on presymptomatic or asymptomatic carrier transmission of COVID-19]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Apr 10;41(4):485-488. doi: 10.3760/cma.j.cn112338-20200228-00207. Chinese.
- Background: PubMed 32109012Gates B. Responding to Covid-19 - A Once-in-a-Century Pandemic? N Engl J Med. 2020 Apr 30;382(18):1677-1679. doi: 10.1056/NEJMp2003762. Epub 2020 Feb 28. No abstract available.
- Background: PubMed 31986258Heymann DL. Data sharing and outbreaks: best practice exemplified. Lancet. 2020 Feb 15;395(10223):469-470. doi: 10.1016/S0140-6736(20)30184-7. Epub 2020 Jan 24. No abstract available.
- Background: PubMed 32119825Hellewell J, Abbott S, Gimma A, Bosse NI, Jarvis CI, Russell TW, Munday JD, Kucharski AJ, Edmunds WJ; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Funk S, Eggo RM. Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts. Lancet Glob Health. 2020 Apr;8(4):e488-e496. doi: 10.1016/S2214-109X(20)30074-7. Epub 2020 Feb 28.
- Background: PubMed 32150796Huh S. How to train health personnel to protect themselves from SARS-CoV-2 (novel coronavirus) infection when caring for a patient or suspected case. J Educ Eval Health Prof. 2020 Jan;17:10. doi: 10.3352/jeehp.2020.17.10. Epub 2020 Mar 7. No abstract available.
- Background: PubMed 32163699Jones DS. History in a Crisis - Lessons for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1681-1683. doi: 10.1056/NEJMp2004361. Epub 2020 Mar 12. No abstract available.
- Background: PubMed 32074416Lipsitch M, Swerdlow DL, Finelli L. Defining the Epidemiology of Covid-19 - Studies Needed. N Engl J Med. 2020 Mar 26;382(13):1194-1196. doi: 10.1056/NEJMp2002125. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32003551Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, Zimmer T, Thiel V, Janke C, Guggemos W, Seilmaier M, Drosten C, Vollmar P, Zwirglmaier K, Zange S, Wolfel R, Hoelscher M. Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany. N Engl J Med. 2020 Mar 5;382(10):970-971. doi: 10.1056/NEJMc2001468. Epub 2020 Jan 30. No abstract available.
- Background: PubMed 32046815Reusken CBEM, Broberg EK, Haagmans B, Meijer A, Corman VM, Papa A, Charrel R, Drosten C, Koopmans M, Leitmeyer K; EVD-LabNet and ERLI-Net. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill. 2020 Feb;25(6):2000082. doi: 10.2807/1560-7917.ES.2020.25.6.2000082. Epub 2020 Feb 11.
- Background: PubMed 32145766Xiao Y, Torok ME. Taking the right measures to control COVID-19. Lancet Infect Dis. 2020 May;20(5):523-524. doi: 10.1016/S1473-3099(20)30152-3. Epub 2020 Mar 5. No abstract available.
- Background: PubMed 32074444Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32087115Xu B, Kraemer MUG; Open COVID-19 Data Curation Group. Open access epidemiological data from the COVID-19 outbreak. Lancet Infect Dis. 2020 May;20(5):534. doi: 10.1016/S1473-3099(20)30119-5. Epub 2020 Feb 19. 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.
Carlo Tomino, PhD study director
IRCCS San Raffaele Pisana
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-Cov2, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 2 inclusion and 4 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 26 Jun 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 Italy. 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?
Number of participants with positive RT-PCR against SARS-CoV2 (time frame: 15 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 NCT04913701, which also lists 12 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 26 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.