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

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ClinicalTrials.gov Identifier: NCT04392323
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ernesto Molmenti, Northwell Health

Tracking Information
First Submitted Date  ICMJE May 15, 2020
First Posted Date  ICMJE May 18, 2020
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE May 13, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2020)		 COVID-19 Test Conversion [ Time Frame: 14 days ]
Patients that have negative pre-operative testing that convert to positive testing 14 days post-discharge
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Duration of Hospitalization [ Time Frame: 14 days ]
    Days from hospital admission to discharge.
  • Rate of self-reported COVID-19 exposure [ Time Frame: 14 days ]
    Patients will be asked to describe if they have had any exposure to COVID-19 positive persons after their hospital stay.
  • Rate of complications from COVID-19 [ Time Frame: 14 days ]
    If patients contract COVID-19 during the postoperative period, what complications occur?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incidence of COVID-19 Test Conversion in Post-surgical Patients
Official Title  ICMJE Incidence of COVID-19 Test Conversion in Post-surgical Patients
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.
Detailed Description

The rapid spread of the COVID-19 infection has led to a near global lockdown including a pause in all elective surgeries [1-6]. Multiple healthcare systems and surgical societies recommended ceasing all elective procedures until this crisis is contained [7-10]. As such, it will be necessary for hospitals to restructure as surgeries increase to protect surgical patients from becoming infected. Our study will be the first to define the test conversion rate of those undergoing surgical procedures during the COVID-19 pandemic. The information gathered from this study can have implications in how surgical centers treat patients during and after this pandemic.

There has been a single study examining postoperative nosocomial infections during the initial incubation period in which 100% of patients developed Sars-CoV-2 viral pneumonia, 14 (44%) required ICU admission with mechanical ventilation, and 7 (20.5%) died after ICU admission [11]. A second cohort of bariatric surgery patients found that 4 of 4 (100%) developed Sars-CoV-2 infections postoperatively with all patients surviving [12]. Another retrospective study found that of 305 patients admitted to the digestive surgery service, 15 (4.9%) developed nosocomial Sars-CoV-2 pneumonia [13]. Of this cohort, two patients died, and seven were hospitalized with six discharged at the time of chart review. Another retrospective non-operative hospital cohort found that 34 of 102 adult patients contracted Sars-CoV-2 as a nosocomial infection. In a review of Gynecologic Oncology procedures in Wuhan the overall nosocomial infection rate was 1.59% (3/189) with two of the three patients being discharged by the publication date [14]. However, in a retrospective review of a general hospital ward in Hong Kong in which the staff used 'vigilant basic infection control measures' 10 patients and 7 staff members that met the definition for close contact were identified and through contact tracing 76 tests were performed on 52 contacts with no Sars-CoV-2 infections identified [15]. Another cohort from Wuhan demonstrated that when performing regional anesthesia (45/49 for Cesarean Section), no anesthetists were infected when complying with level 3 PPE [16].

  1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497-506.
  2. Guan, Wei-jie, et al. "Clinical characteristics of coronavirus disease 2019 in China." New England journal of medicine (2020).
  3. Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet 2020 January 31 (Epub ahead of print).
  4. Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. DOI: 10.1056/NEJMoa2001316.
  5. Hanna, T.P., Evans, G.A. and Booth, C.M., 2020. Cancer, COVID-19 and the precautionary principle: prioritizing treatment during a global pandemic. Nature Reviews Clinical Oncology, 17(5), pp.268-270.
  6. Brindle, M. and Gawande, A., 2020. Managing COVID-19 in surgical systems. Annals of Surgery.
  7. American College of Surgeons (2020). COVID-19: Recommendations for Management of Elective Surgical Procedures. Retrieved March 13, 2020 from https://www.facs.org/covid-19/clinical-guidance/elective-surgery
  8. SAGES (2020). SAGES AND EAES RECOMMENDATIONS REGARDING SURGICAL RESPONSE TO COVID-19 CRISIS. Retrieved March 29, 2020 from https://www.sages.org/recommendations-surgical-response-covid-19/
  9. American Society of Plastic Surgeons (2020). APS Guidance Regarding Elective and Non-Essential Patient Care. Retrieved March 19th , 2020 from https://www.plasticsurgery.org/for-medical-professionals/covid19-member-resources/previous-statements
  10. American College of Obstetrics and Gynecology (2020). Joint Statement: Scheduling Elective Surgeries. Retrieved March 16th, 2020 from https://www.sgo.org/clinical-practice/management/scheduling-elective-surgeries/
  11. S. Lei, F. Jiang, W. Su, et al.Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine (2020), p. 100331
  12. Aminian A, Kermansaravi M, Azizi S, et al. Bariatric Surgical Practice During the Initial Phase of COVID-19 Outbreak [published online ahead of print, 2020 Apr 20]. Obes Surg. 2020;1-4. doi:10.1007/s11695-020-04617-x
  13. Luong-Nguyen M, Hermand H, Abdalla S, et al. Nosocomial infection with SARS-CoV-2 within Deparments of Digestive Surgery. [published ahead of print, 2020 Apr 27] J of Vis Surg. 2020.
  14. 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 [published online ahead of print, 2020 Apr 7]. Oncologist. 2020;10.1634/theoncologist.2020-0157. doi:10.1634/theoncologist.2020-0157
  15. Wong SC, Kwong RT, Wu TC, et al. Risk of nosocomial transmission of coronavirus disease 2019: an experience in a general ward setting in Hong Kong [published online ahead of print, 2020 Apr 4]. J Hosp Infect. 2020; doi:10.1016/j.jhin.2020.03.036
  16. Zhong Q, Liu YY, Luo Q, et al. Spinal anaesthesia for patients with coronavirus disease 2019 and possible transmission rates in anaesthetists: retrospective, single-centre, observational cohort study [published online ahead of print, 2020 Mar 28]. Br J Anaesth. 2020;S0007-0912(20)30161-6. doi:10.1016/j.bja.2020.03.007
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Cohort
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sars-CoV2
Intervention  ICMJE Diagnostic Test: COVID-19 PCR and Serology
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 Arms  ICMJE Experimental: Study Group
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.
Intervention: Diagnostic Test: COVID-19 PCR and Serology
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2020)		 500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients age < 18 years.
  2. Prior documented COVID-19 Infection.
  3. Current hospital inpatient prior to procedure.
  4. Person Under Investigation for COVID-19 infection.
  5. Current use of antiviral medications.
  6. Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) .
  7. Documented immunodeficiency.
  8. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.
  9. Outpatient procedures with planned same-day discharge.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Aaron Nizam, MD 9179570305 anizam1@northwell.edu
Contact: Ernesto Molmenti, MD, PhD, MBA 5165282767 emolmenti@northwell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04392323
Other Study ID Numbers  ICMJE IRB #20-0404
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ernesto Molmenti, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ernesto Molmenti, MD, PhD, MBA Northwell Health
Principal Investigator: Aaron Nizam, MD Northwell Health
PRS Account Northwell Health
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP