COVID-19SCIP-COVID19NCT05346042
Safe and Timely Cessation of Isolation of Patients With COVID-19 (The SCIP-COVID-19) Study
An observational study of COVID-19, run by Anne Voor in 't holt at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- duration infectiousness
- How many people
- 7,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult COVID-19 patients tested positive in the 7 participating hospitals between the end of February 2020 and December 2021.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA
About this study
Official title: 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.
Read more
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.
- Conditions
- COVID-19
- Being tested
- duration infectiousness
- Keywords
- COVID-19, infectiousness duration, isolation, infection prevention control measures
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duration infectiousnessOther
is the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: duration infectiousness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between the end of February 2020 and December 2021
Secondary outcomes (3)
Quantitative Ct-value of RT-PCR
The quantitative Ct-value of RT-PCR as reference standard
Measured: 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
Measured: Between the end of February 2020 and December 2021
Qualitative rapid Ag-test
The rapid Ag-test in qualitative form
Measured: Between the end of February 2020 and December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Dec 2022
- Primary completion1 Feb 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Voor in 't holt
- Sponsor type
- University, hospital or other
- Collaborators
- Maasstad Hospital, Medisch Spectrum Twente, Elisabeth-TweeSteden Ziekenhuis, Julius Center, HagaZiekenhuis, Leiden University Medical Center, Radboud University Medical Center
- Responsible party
- Sponsor-investigator, Anne Voor in 't holt, Erasmus Medical Center
- Investigators
- Margreet C Vos, Prof. dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346042
- Sponsor's protocol ID
- 113189
- Other IDs
- 10430102110003
- Acronym
- SCIP-COVID19
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Timely Cessation of Isolation of Patients With COVID-19, The SCIP-COVID-19
- ClinicalTrials.gov ID
- NCT05346042
- Acronym / sponsor ID
- SCIP-COVID19 / 113189
- Conditions
- COVID-19
- Keywords
- COVID-19, infectiousness duration, isolation, infection prevention control measures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Anne Voor in 't holtUniversity, hospital or other
- Collaborators
- Maasstad Hospital, Medisch Spectrum Twente, Elisabeth-TweeSteden Ziekenhuis, Julius Center, HagaZiekenhuis, Leiden University Medical Center, Radboud University Medical Center
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed Covid-19 | – | Other: duration infectiousnessAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult COVID-19 patients tested positive in the 7 participating hospitals between the end of February 2020 and December 2021.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Adult patients with registered opt-out for using clinical and/or laboratory data.
- Patients <18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duration infectiousnessis the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation | Other | Confirmed Covid-19 |
Primary outcome
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
the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation
3 secondary outcomes
Quantitative Ct-value of RT-PCR
Time frame: Between the end of February 2020 and December 2021
Quantitative SARS-CoV-2 N-Ag concentration in pg/mL
Time frame: Between the end of February 2020 and December 2021
Qualitative rapid Ag-test
Time frame: Between the end of February 2020 and December 2021
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margreet C Vos, Prof. dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Anne Voor in 't holt at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.