Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Sars-CoV2 Diagnostic Test: COVID-19 PCR and Serology Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Cohort
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Incidence of COVID-19 Test Conversion in Post-surgical Patients
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. COVID-19 Test Conversion [ Time Frame: 14 days ]
    Patients that have negative pre-operative testing that convert to positive testing 14 days post-discharge


Secondary Outcome Measures :
  1. Duration of Hospitalization [ Time Frame: 14 days ]
    Days from hospital admission to discharge.

  2. 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.

  3. Rate of complications from COVID-19 [ Time Frame: 14 days ]
    If patients contract COVID-19 during the postoperative period, what complications occur?



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392323


Contacts
Layout table for location contacts
Contact: Aaron Nizam, MD 9179570305 anizam1@northwell.edu
Contact: Ernesto Molmenti, MD, PhD, MBA 5165282767 emolmenti@northwell.edu

Locations
Layout table for location information
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 10030
Contact: Aaron Nizam, MD    917-957-0305    anizam1@northwell.edu   
Contact: Ernesto Molmenti, MD, PhD, MBA    516-528-2767    emolmenti@northwell.edu   
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Aaron Nizam, MD    917-957-0305    anizam1@northwell.edu   
Contact: Ernesto Molmenti, MD, PhD, MBA    516-528-2767    emolmenti@northwell.edu   
Sub-Investigator: Andrew W Menzin, MD, MBA         
Sub-Investigator: Michael Nimaroff, MD, MBA         
Sub-Investigator: James Crawford, MD         
Sub-Investigator: Jose Prince, MD         
Sub-Investigator: Matthew Weiss, MD         
Sub-Investigator: Bruce Farber, MD         
Sub-Investigator: Santiago Miyara, MD         
Sponsors and Collaborators
Northwell Health
Investigators
Layout table for investigator information
Principal Investigator: Ernesto Molmenti, MD, PhD, MBA Northwell Health
Principal Investigator: Aaron Nizam, MD Northwell Health
Publications of Results:

Layout table for additonal information
Responsible Party: Ernesto Molmenti, 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, Northwell Health
ClinicalTrials.gov Identifier: NCT04392323    
Other Study ID Numbers: IRB #20-0404
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ernesto Molmenti, Northwell Health:
Sars-CoV2
surgery
infection
transmission
Covid-19
safety
nosocomial
virus
corona
COVID
incidence