Covid-19 DiseaseNCT04371354
Outcomes of Covid-19 Protective Measures in Endoscopy
An observational study of Covid-19 Disease and Endoscopy Unit, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19 Disease, Endoscopy Unit
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 27 Apr 2020to 27 Dec 2021
- 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: Patients undergoing an endoscopic procedure
Who may be able to join
- patients undergoing an endoscopic procedure with written informed consent given.
- Staff allocated in the endoscopy unit.
Who cannot join
- Refection to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes After Implementation of a Protective Protocol for Covid-19 in Large Spanish Endoscopy Units.
Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit.
Read the detailed description
Detailed description: SARS-Covid-19 virus pandemic has had a big impact both socially and on operation of health facilities. During the Covid-19 outbreak most of the scheduled endoscopies were cancelled and only emergent and urgent endoscopies were performed in the unit. This meant that for six weeks, around 98% of our daily workload was cancelled. During that time the investigators have developed a protocol in order to resume scheduled endoscopic activity in the decreasing phase of the pandemic.
The hypothesis of this prospective observational study is that implementation of a protocol based upon Covid PCR tests and clinical triage is useful to categorize two types of Covid-19 infection risk and two levels of personal protection equipments required.
The primary aim is to evaluate the outcomes of implementing a protective protocol with two levels of protection for Covid-19 in the endoscopy unit. As secondary aims, the investigators, want to evaluate the endoscopy unit staff and patients infection rate after implementation of the protective protocol; and the utility of previous Covid PCR testing and on day clinical triage to discriminate patients before endoscopy.
A brief daily questionnaire will be filled by all the endoscopy unit staff members questioning about type of procedures performed in their allocated endoscopy room, level of protection used and PCR status of their attended patients. Patients will be followed up for a period of two weeks to discard development of Covid-19 disease with possible origin in their visit to the endoscopy unit.
- Conditions
- Covid-19 Disease, Endoscopy Unit
- Keywords
- Covid-19 disease, endoscopy, gastrointestinal, personal protective equipment
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of new Covid infection of patients and staff members
Number of new Covid infection of patients and staff members
Measured: 3 months
Secondary outcomes (3)
Covid disease prevalence in the patients referred to endoscopy
Number of patients referred to endoscopy with Covid disease
Measured: 3 months
Categorization by clinical triage and Covid Test
Categorization of patients by clinical triage and Covid Test
Measured: 3 months
Type of endoscopy procedure and staff protective equipment
Influence of the type of endoscopy procedure and staff protective equipment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start27 Apr 2020
- Primary completion14 Jun 2021
- Study completion27 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan J Vila, MD, PhD, Fundacion Miguel Servet
- Investigators
- Juan J Vila, PhD, Principal investigator, Tertiary referral hospital: Complejo Hospitalario de Navarra. Pamplona.Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371354
- Sponsor's protocol ID
- 2020-COCHE
- Status last verified
- Aug 2021
- First submitted
- 28 Apr 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Implementation of a Protective Protocol for Covid-19 in Large Spanish Endoscopy Units.
- ClinicalTrials.gov ID
- NCT04371354
- Acronym / sponsor ID
- 2020-COCHE
- Conditions
- Covid-19 Disease, Endoscopy Unit
- Keywords
- Covid-19 disease, endoscopy, gastrointestinal, personal protective equipment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 27 Dec 2021 (estimated)
- First posted
- 1 May 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.
Prospective study evaluating the outcomes of implementation of a protective protocol for Covid-19 for patients and staff in a large endoscopy unit.
Detailed description
Detailed description: SARS-Covid-19 virus pandemic has had a big impact both socially and on operation of health facilities. During the Covid-19 outbreak most of the scheduled endoscopies were cancelled and only emergent and urgent endoscopies were performed in the unit. This meant that for six weeks, around 98% of our daily workload was cancelled. During that time the investigators have developed a protocol in order to resume scheduled endoscopic activity in the decreasing phase of the pandemic.
The hypothesis of this prospective observational study is that implementation of a protocol based upon Covid PCR tests and clinical triage is useful to categorize two types of Covid-19 infection risk and two levels of personal protection equipments required.
The primary aim is to evaluate the outcomes of implementing a protective protocol with two levels of protection for Covid-19 in the endoscopy unit. As secondary aims, the investigators, want to evaluate the endoscopy unit staff and patients infection rate after implementation of the protective protocol; and the utility of previous Covid PCR testing and on day clinical triage to discriminate patients before endoscopy.
A brief daily questionnaire will be filled by all the endoscopy unit staff members questioning about type of procedures performed in their allocated endoscopy room, level of protection used and PCR status of their attended patients. Patients will be followed up for a period of two weeks to discard development of Covid-19 disease with possible origin in their visit to the endoscopy unit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing an endoscopic procedure
Key inclusion criteria (2 listed)
- patients undergoing an endoscopic procedure with written informed consent given.
- Staff allocated in the endoscopy unit.
Key exclusion criteria (1 listed)
- Refection to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of new Covid infection of patients and staff members
Time frame: 3 months
Number of new Covid infection of patients and staff members
3 secondary outcomes
Covid disease prevalence in the patients referred to endoscopy
Time frame: 3 months
Categorization by clinical triage and Covid Test
Time frame: 3 months
Type of endoscopy procedure and staff protective equipment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- 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.
Juan J Vila, PhD principal investigator
Tertiary referral hospital: Complejo Hospitalario de Navarra. Pamplona.Spain
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 Disease and Endoscopy Unit, run by Fundacion Miguel Servet at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 8 Sep 2021. 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 Spain. 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?
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?
Rate of new Covid infection of patients and staff members (time frame: 3 months). 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 8 Sep 2021.