Incidence of COVID-19 Test Conversion in Post-surgical Patients

NCT04392323 | Completed

• 1 other identifier: IRB #20-0404
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

The current Sars-CoV-2 (COVID-19) pandemic has created major changes in how physicians perform routine healthcare for our patients, including elective and non-elective surgical procedures. Beginning on March 16th, 2020 Northwell Health postponed all elective surgeries. As the incidence of COVID-19 cases begins to decrease and hospital volume improves we need to ensure the safety of our patients planning surgical procedures. However, at this time there is a scarcity of data regarding the COVID-19 test conversion rate in surgical patients. Our goal is to determine the COVID-19 test conversion rate in these patients to better guide strategies for restarting surgical care in a large-scale pandemic. Patients will be routinely tested with serology and PCR for COVID-19 24-48 hours prior to their scheduled surgery. Those who provide informed consent will be re-tested 12-16 days after discharge from the hospital to determine any potential nosocomial infection rate. Patients will also answer a few questions during their retest to allow the study team to gauge exposure risk postoperatively after leaving the hospital.

Conditions

Sars-CoV2

Keywords

Sars-CoV2; surgery; infection; transmission; Covid-19; safety; nosocomial; virus; corona; COVID; incidence

Outcome Measures

Primary Outcomes (1)

• COVID-19 Test Conversion

  Patients that have negative pre-operative testing that convert to positive testing 14 days post-discharge

  14 days

Secondary Outcomes (3)

• Duration of Hospitalization

  14 days

• Rate of self-reported COVID-19 exposure

  14 days

• Rate of complications from COVID-19

  14 days

Study Arms (1)

Study Group

EXPERIMENTAL

Patients will be recruited as an outpatient prior to their surgical procedure or during their hospital admission. If they consent, they will provide signed informed consent and will receive testing with serology and PCR for COVID-19 infection at pre-surgical testing 24-48 hours prior to their scheduled procedure. If they consent while inpatient postoperatively, signed informed consent will be procured after they have completed their pre-operative COVID-19 testing. PCR for COVID entails obtaining a nasopharyngeal swab to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital.

Diagnostic Test: COVID-19 PCR and Serology

Interventions

COVID-19 PCR and Serology DIAGNOSTIC_TEST

PCR for COVID entails obtaining a nasopharyngeal swab (a cotton tip introduced via the nose to obtain a sample) to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital. Serology implies that a blood sample will be obtained by venipuncture. A volume of 50 ml (about 4 tablespoons) or less of blood will be obtained.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any ethnic background undergoing an elective surgical procedure with a minimum of 24-hour hospital admission.
• Age ≥18.
• Written Voluntary Informed Consent.

You may not qualify if:

• Patients age \< 18 years.
• Prior documented COVID-19 Infection.
• Current hospital inpatient prior to procedure.
• Person Under Investigation for COVID-19 infection.
• Current use of antiviral medications.
• Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) .
• Documented immunodeficiency.
• Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.
• Outpatient procedures with planned same-day discharge.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

North Shore University Hospital

Manhasset, New York, 10030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Related Publications (13)

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  PMID: 31986264 RESULT

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  PMID: 32109013 RESULT

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• Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

  PMID: 31995857 RESULT

• Hanna TP, Evans GA, Booth CM. Cancer, COVID-19 and the precautionary principle: prioritizing treatment during a global pandemic. Nat Rev Clin Oncol. 2020 May;17(5):268-270. doi: 10.1038/s41571-020-0362-6.

  PMID: 32242095 RESULT

• Brindle ME, Gawande A. Managing COVID-19 in Surgical Systems. Ann Surg. 2020 Jul;272(1):e1-e2. doi: 10.1097/SLA.0000000000003923. No abstract available.

  PMID: 32209891 RESULT

• Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.

  PMID: 32292899 RESULT

• Aminian A, Kermansaravi M, Azizi S, Alibeigi P, Safamanesh S, Mousavimaleki A, Rezaei MT, Faridi M, Mokhber S, Pazouki A, Safari S. Bariatric Surgical Practice During the Initial Phase of COVID-19 Outbreak. Obes Surg. 2020 Sep;30(9):3624-3627. doi: 10.1007/s11695-020-04617-x.

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• Yang S, Zhang Y, Cai J, Wang Z. Clinical Characteristics of COVID-19 After Gynecologic Oncology Surgery in Three Women: A Retrospective Review of Medical Records. Oncologist. 2020 Jun;25(6):e982-e985. doi: 10.1634/theoncologist.2020-0157. Epub 2020 Apr 7.

  PMID: 32259322 RESULT

• Wong SCY, Kwong RT, Wu TC, Chan JWM, Chu MY, Lee SY, Wong HY, Lung DC. Risk of nosocomial transmission of coronavirus disease 2019: an experience in a general ward setting in Hong Kong. J Hosp Infect. 2020 Jun;105(2):119-127. doi: 10.1016/j.jhin.2020.03.036. Epub 2020 Apr 4.

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• Zhong Q, Liu YY, Luo Q, Zou YF, Jiang HX, Li H, Zhang JJ, Li Z, Yang X, Ma M, Tang LJ, Chen YY, Zheng F, Ke JJ, Zhang ZZ. Spinal anaesthesia for patients with coronavirus disease 2019 and possible transmission rates in anaesthetists: retrospective, single-centre, observational cohort study. Br J Anaesth. 2020 Jun;124(6):670-675. doi: 10.1016/j.bja.2020.03.007. Epub 2020 Mar 28.

  PMID: 32234250 RESULT

• Nizam A, Nimaroff ML, Menzin AW, Goldberg GL, Miyara SJ, Molmenti E. Nosocomial COVID-19 infection in women undergoing elective cesarean delivery: a prospective cohort study. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100490. doi: 10.1016/j.ajogmf.2021.100490. Epub 2021 Sep 17.

  PMID: 34543753 DERIVED

MeSH Terms

Conditions

Infections; COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ernesto Molmenti, MD, PhD, MBA

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Aaron Nizam, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman of Surgery - Chief of Innovation. North Shore University Hospital, Northwell Health. Professor of Surgery, Medicine, and Pediatrics, Zucker School of Medicine at Hofstra/Northwell

Model Details: Prospective Cohort

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 18, 2020
• Study Start: May 13, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 4, 2020
• Last Updated: November 8, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)