Clinical trial NCT04374123: COVID-19 Serology Screening and Strict Protocol in the Endoscopy Unit
Official title: COVID-19 Serologic Screening and a Strict Protocol in the Management of a Referral Gastrointestinal Endoscopy Unit: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study.
timeFrame: through study completion, an average of 30 days
measure: Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.
timeFrame: through study completion, an average 30 days
measure: Technical success rate of endoscopic procedures during the 30-days study period.
timeFrame: through study completion, an average 30 days
measure: IgG and IgM against COVID-19 in the endoscopy staff measured at the end of the study.
timeFrame: through study completion, an average 30 days
measure: Adverse events rate of endoscopic procedures during the 30-days
timeFrame: through study completion, an average 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Ecuadorian Institute of Digestive Diseases
state: Guayas
Study officials:
References:
citation: 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.
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.gastro.2020.04.003. Epub 2020 Apr 10. No abstract available.
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. No abstract available.