Safe and Timely Cessation of Isolation of Patients with COVID-19 (The SCIP-COVID-19) Study (SCIP-COVID19)

Safe and Timely Cessation of Isolation of Patients with COVID-19, the SCIP-COVID-19

Rationale:

In the treatment, care and isolation of COVID-19 patients, one of the most important issues is determining the duration of infectiousness. The current Dutch guideline advises at least 14 days of isolation for seriously ill patients, which is the case for most admitted patients, and at least 21 days for intubated patients. It is believed that in most cases this isolation duration is too long, which is highly undesirable for patients staying in closed single-occupancy rooms. This is known to result in limited contact with healthcare workers (HCW) and to be associated with a higher level of depression among patients. The longer the isolation, the higher the workload for HCW and the higher the costs (e.g. with about 0.5 million admission days in the Netherlands, these work out at about €14 million on personal protective equipment [PPE] and cleaning alone). Additionally, isolation demands a larger healthcare workforce, yielding less capacity to provide other care to non-COVID-19 patients, with numerous other consequences. On the other hand, it is possible that some patients were discontinued from isolation too early, leading to a risk of transmission to other patients and to HCW. In conclusion, duration of isolation should be as short as possible for proper patient flow and to avoid unnecessary burden to patients and HCW, and thus to healthcare in general. Therefore, there is an urgent need to define the period of infectiousness of COVID-19. We will develop a safe and effective algorithm for decision on timely discontinuation of isolation of COVID-19 hospitalized patients.

Objective:

The ultimate goal of this project is to produce new evidence-based criteria for the termination of isolation of hospitalized COVID-19 patients that are safe (very low subsequent risk of transmission to other patients or healthcare workers) while reducing the number of unnecessary days in isolation (thereby improving quality of life of patients, reducing hospital costs, and making optimal use of the scarce number of isolation beds). Multiple sources of data and evidence will be integrated to arrive at these new criteria.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: duration infectiousness

Detailed Description

Rationale:

In the treatment, care and isolation of COVID-19 patients, one of the most important issues is determining the duration of infectiousness. The current Dutch guideline advises at least 14 days of isolation for seriously ill patients, which is the case for most admitted patients, and at least 21 days for intubated patients. It is believed that in most cases this isolation duration is too long, which is highly undesirable for patients staying in closed single-occupancy rooms. This is known to result in limited contact with healthcare workers (HCW) and to be associated with a higher level of depression among patients. The longer the isolation, the higher the workload for HCW and the higher the costs (e.g. with about 0.5 million admission days in the Netherlands, these work out at about €14 million on personal protective equipment [PPE] and cleaning alone). Additionally, isolation demands a larger healthcare workforce, yielding less capacity to provide other care to non-COVID-19 patients, with numerous other consequences. On the other hand, it is possible that some patients were discontinued from isolation too early, leading to a risk of transmission to other patients and to HCW. In conclusion, duration of isolation should be as short as possible for proper patient flow and to avoid unnecessary burden to patients and HCW, and thus to healthcare in general. Therefore, there is an urgent need to define the period of infectiousness of COVID-19. We will develop a safe and effective algorithm for decision on timely discontinuation of isolation of COVID-19 hospitalized patients.

Objective:

The ultimate goal of this project is to produce new evidence-based criteria for the termination of isolation of hospitalized COVID-19 patients that are safe (very low subsequent risk of transmission to other patients or healthcare workers) while reducing the number of unnecessary days in isolation (thereby improving quality of life of patients, reducing hospital costs, and making optimal use of the scarce number of isolation beds). Multiple sources of data and evidence will be integrated to arrive at these new criteria.

Study design:

This is a retrospective cohort and technical laboratory study.

Study population:

All adult COVID-19 patients tested positive in the 7 participating hospitals identified between the end of February 2020 and December 2021.

Main study endpoint:

The main outcome of interest is the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3000 CA
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All adult COVID-19 patients tested positive in the 7 participating hospitals between the end of February 2020 and December 2021.

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Admission for COVID-19 and tested positive between the end of February 2020 and December 1st 2021.
• Admission for other reasons than COVID-19, but during hospital stay detected with COVID-19.
• Patients ≥18 years old.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded:

• Adult patients with registered opt-out for using clinical and/or laboratory data.
• Patients <18 years old.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Confirmed Covid-19; All adult COVID-19 patients and health care workers tested positive in the 7 participating hospitals identified between the end of February 2020 and December 2021.	Other: duration infectiousness; is the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation	the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation	Between the end of February 2020 and December 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Ct-value of RT-PCR	The quantitative Ct-value of RT-PCR as reference standard	Between the end of February 2020 and December 2021
Quantitative SARS-CoV-2 N-Ag concentration in pg/mL	The quantitative SARS-CoV-2 N-Ag concentration in pg/mL	Between the end of February 2020 and December 2021
Qualitative rapid Ag-test	The rapid Ag-test in qualitative form	Between the end of February 2020 and December 2021

Collaborators and Investigators

• Sponsor: Anne Voor in 't holt
• Collaborators: Radboud University Medical Center; Leiden University Medical Center; Elisabeth-TweeSteden Ziekenhuis; Maasstad Hospital; Medisch Spectrum Twente; Julius Center; HagaZiekenhuis
• Investigators: Principal Investigator: Margreet C Vos, Prof. dr., Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): February 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; isolation; infectiousness duration; infection prevention control measures
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 113189; 10430102110003 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Other researchers will be able to find the metadata in the data repository on the COVID-19 national Health-RI portal. They could express their interest in the dataset through a.voorintholt@erasmusmc.nl. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the COVID-19 national health RI portal.
• IPD Sharing Time Frame: At least 10 years
• IPD Sharing Access Criteria: Researchers could express their interest in the dataset through a.voorintholt@erasmusmc.nl. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the COVID-19 national health RI portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No