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

Sars-CoV2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392323
• Other study ID #: IRB #20-0404
• Status: Completed
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: October 4, 2020

Study information

• Verified date: May 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/previo us-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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 4, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV2

Intervention

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.

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (12)

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: 10.100 — View Citation

Brindle ME, Gawande A. Managing COVID-19 in Surgical Systems. Ann Surg. 2020 Jul;272(1):e1-e2. doi: 10.1097/SLA.0000000000003923. — View Citation

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ — View Citation

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. — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 20 — View Citation

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. — View Citation

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, — View Citation

Luong-Nguyen M, Hermand H, Abdalla S, Cabrit N, Hobeika C, Brouquet A, Goéré D, Sauvanet A. Nosocomial infection with SARS-Cov-2 within Departments of Digestive Surgery. J Visc Surg. 2020 Jun;157(3S1):S13-S18. doi: 10.1016/j.jviscsurg.2020.04.016. Epub 20 — View Citation

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.2020.03.0 — View Citation

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 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub — View Citation

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. — View Citation

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 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 Test Conversion	Patients that have negative pre-operative testing that convert to positive testing 14 days post-discharge	14 days
Secondary	Duration of Hospitalization	Days from hospital admission to discharge.	14 days
Secondary	Rate of self-reported COVID-19 exposure	Patients will be asked to describe if they have had any exposure to COVID-19 positive persons after their hospital stay.	14 days
Secondary	Rate of complications from COVID-19	If patients contract COVID-19 during the postoperative period, what complications occur?	14 days