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

Completed

• Conditions: COVID

• Registration Number: NCT04374123
• Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

Brief 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.

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 Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-05-02
• Study First Posted: 2020-05-05
• Primary Completion: 2020-05-20
• Study Completion: 2020-06-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.	through study completion, an average 30 days	Endoscopic records of patients treated during the COVID-19 protocol
Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study.	through study completion, an average of 30 days	COVID-19 infection in the staff documented via PCR
Technical success rate of endoscopic procedures during the 30-days study period.	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.	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	through study completion, an average 30 days	adverse events of endoscopic procedures

Trial Locations

Locations (1)

Ecuadorian Institute of Digestive Diseases; 🇪🇨 Guayaquil, Guayas, Ecuador