COVIDNCT04374123
COVID-19 Serology Screening and Strict Protocol in the Endoscopy Unit
An observational study of COVID, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly two-thirds of the COVID-positive patients in the country and nearly 40% of infected individuals are health-care related personnel. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID
- What is being tested?
- Serological screening for IgG and IgM antibodies against COVID-19
- How many people
- 111 participants
- Where
- 1 siteEcuador
- Study dates
- 20 Apr 2020to 15 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Consecutive adult patients from the Endoscopy Unit at the Instituto Ecuatoriano de Enfermedades Digestivas, Guayaquil, Ecuador. Patients that completed screening questionnaire and serological screening for COVID-109 before the performance of the endoscopic procedures.
Who may be able to join
- Patients willing to participate
- Available serum samples for IgG and IgG antibodies against COVID-19
- Ability to complete the screening questionnaire
Who cannot join
- Patients with respiratory symptoms
- Patients with COVID-19 active infection
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505
About this study
Official title: COVID-19 Serologic Screening and a Strict Protocol in the Management of a Referral Gastrointestinal Endoscopy Unit: a Prospective Study
The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly two-thirds of the COVID-positive patients in the country and nearly 40% of infected individuals are health-care related personnel.
Nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during the COVID-19 pandemic. Several experiences in the management of the endoscopic unit during the pandemic has been proposed. We aimed to prospectively evaluate a strict protocol for preventing potential nosocomial infection of COVID-19.
Read the detailed description
Consecutive patients with appointment for endoscopic examination and procedures will be contacted via a telephone call by a pulmonologist, who will perform a triage with a screening questionnaire between 24-48 hours before the scheduled procedure. The pulmonologist will seek for history of fever, respiratory symptoms, and/or close-contacts COVID-patients. After exclusion of all respiratory symptoms or history suggestive of COVID-19, patients will be evaluated for serum IgG and IgM levels using a rapid test.
Only after complete evaluation and revision of serological levels, body temperature will be measure before entering the endoscopy unit. Patients will be isolated in an individual preoperative and recovery room after the endoscopic procedure, avoiding contacts with other patients. The endoscopy staff (endoscopists, nurses, administrative personal, anesthesia staff) will use personal protective equipment (PPE) including N95 face mask, face shield, shoe covers, gowns, and gloves.
All the staff will be evaluated for nucleic acid PCR testing within three days before resuming activities in the endoscopy unit, all staff members will be evaluated for respiratory symptoms and changes in body temperature before starting daily activities. At the end of the study all the staff will be evaluated for IgM and IgG antibodies against COVID-19.
- Conditions
- COVID
- Being tested
- Serological screening for IgG and IgM antibodies against COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological screening for IgG and IgM antibodies against COVID-19Diagnostic test
Serum evaluation for IgG and IgM antibodies against COVID-19 in patients in the endoscopy unit during the COVID 19 pandemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study.
COVID-19 infection in the staff documented via PCR
Measured: through study completion, an average of 30 days
Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.
Endoscopic records of patients treated during the COVID-19 protocol
Measured: through study completion, an average 30 days
Technical success rate of endoscopic procedures during the 30-days study period.
technical success of endoscopic procedures
Measured: through study completion, an average 30 days
IgG and IgM against COVID-19 in the endoscopy staff measured at the end of the study.
serum levels of IgG and IgM against COVID-19
Measured: through study completion, an average 30 days
Adverse events rate of endoscopic procedures during the 30-days
adverse events of endoscopic procedures
Measured: through study completion, an average 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start20 Apr 2020
- Primary completion20 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374123
- Sponsor's protocol ID
- IECED-04-15-covid
- Status last verified
- Jul 2020
- First submitted
- 20 Apr 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han J, Wang Y, Zhu L, Cui Y, Li L, Zeng Z, Zhang S. Preventing the spread of COVID-19 in digestive endoscopy during the resuming period: meticulous execution of screening procedures. Gastrointest Endosc. 2020 Aug;92(2):445-447. doi: 10.1016/j.gie.2020.03.3855. Epub 2020 Apr 5. No abstract available.
PubMed 32268134Repici A, Pace F, Gabbiadini R, Colombo M, Hassan C, Dinelli M; ITALIAN GI-COVID19 Working Group. Endoscopy Units and the Coronavirus Disease 2019 Outbreak: A Multicenter Experience From Italy. Gastroenterology. 2020 Jul;159(1):363-366.e3. doi: 10.1053/j.gastro.2020.04.003. Epub 2020 Apr 10. No abstract available.
PubMed 32283102Thompson CC, Shen L, Lee LS. COVID-19 in endoscopy: Time to do more? Gastrointest Endosc. 2020 Aug;92(2):435-439. doi: 10.1016/j.gie.2020.03.3848. Epub 2020 Mar 29. No abstract available.
PubMed 32234312
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Serologic Screening and a Strict Protocol in the Management of a Referral Gastrointestinal Endoscopy Unit: a Prospective Study
- ClinicalTrials.gov ID
- NCT04374123
- Acronym / sponsor ID
- IECED-04-15-covid
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 5 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.
The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly two-thirds of the COVID-positive patients in the country and nearly 40% of infected individuals are health-care related personnel.
Nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during the COVID-19 pandemic. Several experiences in the management of the endoscopic unit during the pandemic has been proposed. We aimed to prospectively evaluate a strict protocol for preventing potential nosocomial infection of COVID-19.
Detailed description
Consecutive patients with appointment for endoscopic examination and procedures will be contacted via a telephone call by a pulmonologist, who will perform a triage with a screening questionnaire between 24-48 hours before the scheduled procedure. The pulmonologist will seek for history of fever, respiratory symptoms, and/or close-contacts COVID-patients. After exclusion of all respiratory symptoms or history suggestive of COVID-19, patients will be evaluated for serum IgG and IgM levels using a rapid test.
Only after complete evaluation and revision of serological levels, body temperature will be measure before entering the endoscopy unit. Patients will be isolated in an individual preoperative and recovery room after the endoscopic procedure, avoiding contacts with other patients. The endoscopy staff (endoscopists, nurses, administrative personal, anesthesia staff) will use personal protective equipment (PPE) including N95 face mask, face shield, shoe covers, gowns, and gloves.
All the staff will be evaluated for nucleic acid PCR testing within three days before resuming activities in the endoscopy unit, all staff members will be evaluated for respiratory symptoms and changes in body temperature before starting daily activities. At the end of the study all the staff will be evaluated for IgM and IgG antibodies against COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients from the Endoscopy Unit at the Instituto Ecuatoriano de Enfermedades Digestivas, Guayaquil, Ecuador. Patients that completed screening questionnaire and serological screening for COVID-109 before the performance of the endoscopic procedures.
Key inclusion criteria (3 listed)
- Patients willing to participate
- Available serum samples for IgG and IgG antibodies against COVID-19
- Ability to complete the screening questionnaire
Key exclusion criteria (2 listed)
- Patients with respiratory symptoms
- Patients with COVID-19 active infection
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 |
|---|---|---|
| Serological screening for IgG and IgM antibodies against COVID-19Serum evaluation for IgG and IgM antibodies against COVID-19 in patients in the endoscopy unit during the COVID 19 pandemic | Diagnostic test | – |
Primary outcome
Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study.
Time frame: through study completion, an average of 30 days
COVID-19 infection in the staff documented via PCR
Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.
Time frame: through study completion, an average 30 days
Endoscopic records of patients treated during the COVID-19 protocol
Technical success rate of endoscopic procedures during the 30-days study period.
Time frame: through study completion, an average 30 days
technical success of endoscopic procedures
IgG and IgM against COVID-19 in the endoscopy staff measured at the end of the study.
Time frame: through study completion, an average 30 days
serum levels of IgG and IgM against COVID-19
Adverse events rate of endoscopic procedures during the 30-days
Time frame: through study completion, an average 30 days
adverse events of endoscopic procedures
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 28 Jul 2020.
- Results publication: PubMed 32268134Han J, Wang Y, Zhu L, Cui Y, Li L, Zeng Z, Zhang S. Preventing the spread of COVID-19 in digestive endoscopy during the resuming period: meticulous execution of screening procedures. Gastrointest Endosc. 2020 Aug;92(2):445-447. doi: 10.1016/j.gie.2020.03.3855. Epub 2020 Apr 5. No abstract available.
- Results publication: PubMed 32283102Repici A, Pace F, Gabbiadini R, Colombo M, Hassan C, Dinelli M; ITALIAN GI-COVID19 Working Group. Endoscopy Units and the Coronavirus Disease 2019 Outbreak: A Multicenter Experience From Italy. Gastroenterology. 2020 Jul;159(1):363-366.e3. doi: 10.1053/j.gastro.2020.04.003. Epub 2020 Apr 10. No abstract available.
- Results publication: PubMed 32234312Thompson CC, Shen L, Lee LS. COVID-19 in endoscopy: Time to do more? Gastrointest Endosc. 2020 Aug;92(2):435-439. doi: 10.1016/j.gie.2020.03.3848. Epub 2020 Mar 29. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 28 Jul 2020. 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 Ecuador. 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?
Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study. (time frame: through study completion, an average of 30 days). The study lists 5 primary outcomes in all. 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 NCT04374123, which also lists 3 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 28 Jul 2020.