COVID-19 Serology Screening and Strict Protocol in the Endoscopy Unit

COVID Clinical Trial

Official title:

COVID-19 Serologic Screening and a Strict Protocol in the Management of a Referral Gastrointestinal Endoscopy Unit: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374123
• Other study ID #: IECED-04-15-covid
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: July 2020
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 15, 2020
• Est. primary completion date: May 20, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients willing to participate

• Available serum samples for IgG and IgG antibodies against COVID-19

• Ability to complete the screening questionnaire

Exclusion Criteria:

• Patients with respiratory symptoms

• Patients with COVID-19 active infection

Related Conditions & MeSH terms

• COVID

Intervention

Diagnostic Test:
• Serological screening for IgG and IgM antibodies against COVID-19
Serum evaluation for IgG and IgM antibodies against COVID-19 in patients in the endoscopy unit during the COVID 19 pandemic

Locations

Country	Name	City	State
Ecuador	Ecuadorian Institute of Digestive Diseases	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (3)

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. — View Citation

Repici 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. — View Citation

Thompson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 30 days
Primary	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	through study completion, an average 30 days
Primary	Technical success rate of endoscopic procedures during the 30-days study period.	technical success of endoscopic procedures	through study completion, an average 30 days
Primary	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	through study completion, an average 30 days
Primary	Adverse events rate of endoscopic procedures during the 30-days	adverse events of endoscopic procedures	through study completion, an average 30 days