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Completed

NCT Number: NCT04374123

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

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.

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Key information

Conditions

COVID

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serological screening for IgG and IgM antibodies against COVID-19

Diagnostic Test

Serum evaluation for IgG and IgM antibodies against COVID-19 in patients in the endoscopy unit during the COVID 19 pandemic

Primary outcomes

  1. Rate of COVID-19 nosocomial infection among the endoscopy staff at the end of the 30-days study.

    Time frame: through study completion, an average of 30 days

    COVID-19 infection in the staff documented via PCR

  2. Numbers of patients evaluated and treated during the COVID-19 outbreak in the endoscopy unit at the end of the 30-days study.

    Time frame: through study completion, an average 30 days

    Endoscopic records of patients treated during the COVID-19 protocol

  3. Technical success rate of endoscopic procedures during the 30-days study period.

    Time frame: through study completion, an average 30 days

    technical success of endoscopic procedures

  4. IgG and IgM against COVID-19 in the endoscopy staff measured at the end of the study.

    Time frame: through study completion, an average 30 days

    serum levels of IgG and IgM against COVID-19

  5. Adverse events rate of endoscopic procedures during the 30-days

    Time frame: through study completion, an average 30 days

    adverse events of endoscopic procedures

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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