Clinical trial NCT05346042: Safe and Timely Cessation of Isolation of Patients With COVID-19 (The SCIP-COVID-19) Study
Official title: Safe and Timely Cessation of Isolation of Patients With COVID-19, The SCIP-COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Keywords: COVID-19
infectiousness duration
isolation
infection prevention control measures
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Maasstad Hospital
name: Medisch Spectrum Twente
name: Elisabeth-TweeSteden Ziekenhuis
name: Julius Center
name: HagaZiekenhuis
name: Leiden University Medical Center
name: Radboud University Medical Center
First posted: 2022-04-26
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation
timeFrame: Between the end of February 2020 and December 2021
Secondary outcomes:
measure: Quantitative Ct-value of RT-PCR
timeFrame: Between the end of February 2020 and December 2021
measure: Quantitative SARS-CoV-2 N-Ag concentration in pg/mL
timeFrame: Between the end of February 2020 and December 2021
measure: Qualitative rapid Ag-test
timeFrame: Between the end of February 2020 and December 2021
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Margreet C Vos, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: