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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05346042
Acronym
SCIP-COVID19
Enrollment
7000
Registered
2022-04-26
Start date
2022-12-01
Completion date
2025-12-31
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, infectiousness duration, isolation, infection prevention control measures

Brief 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.

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.

Interventions

OTHERduration infectiousness

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolationBetween the end of February 2020 and December 2021the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation

Secondary

MeasureTime frameDescription
Quantitative Ct-value of RT-PCRBetween the end of February 2020 and December 2021The quantitative Ct-value of RT-PCR as reference standard
Quantitative SARS-CoV-2 N-Ag concentration in pg/mLBetween the end of February 2020 and December 2021The quantitative SARS-CoV-2 N-Ag concentration in pg/mL
Qualitative rapid Ag-testBetween the end of February 2020 and December 2021The rapid Ag-test in qualitative form

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026