Status:
COMPLETED
Increased Risk of SARS-CoronaVirus-2 (SARS-CoV-2) Infection Associated With Endoscopy (DECORE Study)
Lead Sponsor:
Hospital del Rio Hortega
Conditions:
SARS-CoV 2
COVID
Eligibility:
All Genders
18+ years
Brief Summary
The aim of our study to compare the proportion of patients who develop SARS-CoV-2 disease in 3 groups: patients undergoing a abdominal ultrasound examination in a Specialty Center, patients undergoing...
Detailed Description
Patients will undergo a telephonic interview 48-96h before the procedure where will ask about the presence of symptoms suggestive of SARS-CoV-2 infection. Optionally, they will also be carried out a s...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients scheduled for an ambulatory endoscopy, an ambulatory abdominal ultrasound, or a telephonic visit Age younger than 18 years.
- Exclusion criteria:
- Refusal to sign the informed consent Immunosuppression (steroid treatment with a dose of 20 mg or more of prednisone daily, azathioprine, cyclosporine, mercaptopurine, methotrexate, mycophenolate, tacrolimus, everolimus, chemotherapeutic agents, anti-tumoral necrosis factor (TNF)-α drugs or other biological treatments for inflammatory bowel disease) Immunodeficiency due to a non-pharmacological cause (HIV, hematological dyscrasias, primary immunodeficiencies ...) Previous confirmed diagnosis (by PCR or serology) of SARS-CoV-2 disease. Diagnosis of previous suspicion (documented in the medical history by a physician) of SARS-CoV-2 disease.
- Previous clinical picture compatible with SARS-CoV-2 in the previous 2 months (defined as any positive response to the check-list questionnaire contained in Annex III) Cognitive impairment or hearing impairment preventing the phone visit Habitual residence outside the province of Valladolid Ultrasound interventionism (liver biopsy, ultrasound-guided paracentesis, biliary drainage ...)
Exclusion
Key Trial Info
Start Date :
May 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04401033
Start Date
May 11 2020
End Date
June 30 2020
Last Update
July 28 2020
Active Locations (1)
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1
Hospital Rio Hortega
Valladolid, Spain, 47012