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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID

Intervention / Treatment
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* Diagnostic Test: Serological screening for IgG and IgM antibodies against COVID-19


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Technical success rate of endoscopic procedures during the 30-days study period. | technical success of endoscopic procedures | 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 | through study completion, an average 30 days | 
| Adverse events rate of endoscopic procedures during the 30-days | adverse events of endoscopic procedures | through study completion, an average 30 days |