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Active, not recruitingNCT05346042SCIP-COVID19Updated Mar 5, 2025

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

An observational study in COVID-19, sponsored by Anne Voor in 't holt. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Anne Voor in 't holt · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
7,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19

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Keywords

  • COVID-19
  • infectiousness duration
  • isolation
  • infection prevention control measures
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 7,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Anne Voor in 't holt as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
7,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Between the end of February 2020 and December 2021

Secondary outcomes

  1. Quantitative Ct-value of RT-PCR

    The quantitative Ct-value of RT-PCR as reference standard

    Time frame: Between the end of February 2020 and December 2021

  2. Quantitative SARS-CoV-2 N-Ag concentration in pg/mL

    The quantitative SARS-CoV-2 N-Ag concentration in pg/mL

    Time frame: Between the end of February 2020 and December 2021

  3. Qualitative rapid Ag-test

    The rapid Ag-test in qualitative form

    Time frame: Between the end of February 2020 and December 2021

07

Study locations

1 site
  • Erasmus Medical Center
    Rotterdam, Zuid-Holland 3000 CA, Netherlands
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05346042
Lead sponsor
Anne Voor in 't holt
Collaborators
Maasstad Hospital, Medisch Spectrum Twente, Elisabeth-TweeSteden Ziekenhuis, Julius Center, HagaZiekenhuis, Leiden University Medical Center, Radboud University Medical Center
Responsible party
Anne Voor in 't holt (Epidemiologist, Assistant Professor, Erasmus Medical Center) — Sponsor-investigator
First posted
Apr 26, 2022
Start date
Dec 1, 2022
Primary completion
Feb 1, 2025
Completion
Dec 31, 2025 (estimated)
Last update
Mar 5, 2025

Study contacts

Margreet C Vos, Prof. dr.
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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