NCT04374123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

April 20, 2020

Last Update Submit

July 27, 2020

Conditions

COVID

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients willing to participate
  • Available serum samples for IgG and IgG antibodies against COVID-19
  • Ability to complete the screening questionnaire

You may not qualify if:

  • Patients with respiratory symptoms
  • Patients with COVID-19 active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

Location

Related 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.2020.03.3855. Epub 2020 Apr 5. No abstract available.

    PMID: 32268134RESULT

  • 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.

    PMID: 32283102RESULT

  • 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.

    PMID: 32234312RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 5, 2020

Study Start

April 20, 2020

Primary Completion

May 20, 2020

Study Completion

June 15, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

EC(1)