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

COVID-19 Clinical Trial

— SCIP-COVID19  

Official title:

Safe and Timely Cessation of Isolation of Patients With COVID-19, The SCIP-COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346042
• Other study ID #: 113189
• Secondary ID: 10430102110003
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Anne F Voor in 't holt, Dr
• Phone: +31 10 703 35 10
• Email: a.voorintholt[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (8)

Lead Sponsor	Collaborator
Anne Voor in 't holt	Elisabeth-TweeSteden Ziekenhuis, HagaZiekenhuis, Julius Center, Leiden University Medical Center, Maasstad Hospital, Medisch Spectrum Twente, Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Qualitative rapid Ag-test	The rapid Ag-test in qualitative form	Between the end of February 2020 and December 2021